Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Heart and Blood Diseases

Rare Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphosarcoma

A prebiotic nutritional supplement available at commercial grocery and health food stores. Specifically, we will be using Bob's Red Mill® potato starch.

Resistant Starch

A starch commonly used as a placebo in prebiotic trials that is digested in the stomach and rapidly absorbed

Maltodextrin

Jayson Henrickson, MS

Taylor A Johnson, BS, MA

Christopher R D'Angelo, MD

Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma. This study hypothesises that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell engraftment. To test this, participants will either have RS or a placebo (maltodextrin) mixed into a food item of their choice for approximately 10 days prior to stem cell infusion and continue to the first day of neutrophil engraftment. The study will look at the difference in gut microbiome diversity between the RS and placebo arm collected at the engraftment timepoint, dietary evaluation to assess the impact of subject diet on microbiome response to intervention and serum sample collection to assess differences to gut permeability during transplant.

Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma, but no strategies have been identified to date that specifically target the gut microbiome. The investigators hypothesize that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell engraftment.

To test this hypothesis, the study will be a randomized, double-blind, placebo-controlled trial of resistant starch versus placebo (maltodextrin) in participants with myeloma or lymphoma undergoing autologous stem cell transplantation. Thirty subjects will be randomized 1:1 to the RS or placebo arm, dosed at 20g daily for 3 days followed by an increased to 20g twice a day mixed into a food item of the participant's choice. The intervention will begin approximately 10 days prior to stem cell infusion and will continue until the first day of neutrophil engraftment (first day absolute neutrophil count \>500) or approximately 30 days in total. Fecal samples will be collected at 4 timepoints for microbiome analysis: 1) at study enrollment 2) day of stem cell infusion 3) day +7 post auto transplant and 4) first day of engraftment defined as absolute neutrophil count \>500 (approximately 10-14 days post-transplant).

The primary endpoint will be the difference in gut microbiome diversity between the RS and placebo arm collected at the engraftment timepoint. Secondary endpoints will include dietary evaluation to assess the impact of subject diet on microbiome response to intervention and serum sample collection to assess differences to gut permeability during transplant.

Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation

A Pilot, Randomized, Double-blind, Placebo-controlled Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation in Multiple Myeloma and Lymphoma: The PRIMAL Trial

To understand the feasibility of the intervention in the proposed study population, the percentage of subjects who adhere to \>70% of scheduled doses will be calculated

To evaluate the duration of hospitalization according to intervention assignment by measuring time from stem cell transplant to day of discharge.

To estimate the rate of neutropenic fever in the post-transplant setting according to intervention assignment. This is captured by cumulative incidence of neutropenic fever (ANC \<1000, temperature \>38.0⁰C) by day 30 according to intervention assignment

To determine the rate of broad-spectrum antibiotic exposure during transplant according to intervention assignment by measuring the proportion of subjects receiving systemic antibiotic exposure.

To determine the rate of gastrointestinal symptoms according to intervention assignment by using the patient-reported gastrointestinal symptom rating scale (GSRS.)

University of Nebraska

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

70g high-amylose maize starch which contains 42g of type 2 resistant starch

70g of fully digestible starch comprised of amylopectin corn starch.

70g of fully digestible starch amylopectin corn starch

Resistant starch

Gabriela Riscuta

Alaska native people (AN) have the highest recorded incidence and death rate from colon cancer in the world (\>90:100,000). We hypothesize that the AN, despite their high consumption of anti-inflammatory and antineoplastic n-3 fish oils, are at increased risk of colon cancer because of colonic butyrate deficiency resulting from their remarkably low consumption of fiber-containing foods. We hypothesize that fiber supplementation of their usual diet will result in a bloom of butyrate producing microbes in the colon, resulting in increased butyrate production, which will suppress their high microbial secondary bile acid production, antagonize the actions of other food (smoked fish) and environmental carcinogens (tobacco, alcohol), and interact with the high circulating levels of n-3 fish oils to suppress colonic inflammation and cancer risk. In order to investigate this, we will conduct a randomized double-blinded 4-week clinical trial in up to 100 randomizable healthy, middle-aged AN undergoing screening colonoscopy, with the objective of obtaining 60 completed interventions. The interventions will consist of either a high-dose soluble fiber supplement given as a drink, together with their usual diet which currently contains about 15g total fiber/d, or to a control digestible starch drink plus their usual diet. The primary endpoint will be a clinically significant reduction in Ki67 proliferative colonic mucosal biomarkers of cancer risk. Microbiome and metabolome mechanisms responsible for the anticipated changes in mucosal biomarkers will also be investigated. Our results in extreme risk AN will be further evaluated by comparison to similar measurements previously made in minimal risk rural Africans and intermediate risk African Americans. Our results will be used to provide the scientific basis for a definitive large-scale high-fiber supplementation study (to achieve \>50g total fiber/d) to suppress adenomatous polyp recurrence following colonoscopy.

Randomization for the double blind, placebo controlled, clinical trial: Recruitment will continue until 60 volunteers have completed the intervention study. Based on previous experience with similar studies, we anticipate 20% of screened patients to be ineligible or drop out, which means, so we plan on consenting and screening approximately 100 potential participants. Baseline data from these participants will be retained. Individuals will be randomized via minimisation (based on age, sex, polypectomy, high fish consumption, and BMI - factors that might influence microbiota composition and function)) to either the resistant starch (RS) group or the control digestible starch (DS) group upon completion of the Stabilization Period.

1. RS Group: Participants will continue with their usual diet plus fiber supplement given as a daily dose of 70g high-amylose maize starch (HAM-RS, HI-MAIZE®260: Ingredion Incorporated, Bridgewater, NJ), which contains 42g of type 2 resistant starch, for 4 weeks. Data from previous studies\[69\] suggests that their usual diet will contain approximately 13g dietary fiber/day, chiefly insoluble, indicating that total fiber intake would be approx. 55g/d. Supplements will be pre-weighed out in batches from the same source and kept in airtight containers. The supplement may be taken as a single or divided dose dissolved in 250ml water, low fat milk, or orange juice
2. DS (Control) Group participants will continue on their usual diet, plus 70g of fully digestible starch (waxy corn starch comprised of amylopectin, AMIOCA® corn starch, Ingredion Incorporated, Bridgewater, NJ ) weighed out, analyzed, and prepared as previously. The RS and control supplements will appear and taste similar, allowing for coding and distribution in a double-blind fashion. The supplements will be equicaloric.

Interventions will include fecal and colonic content sampling for measurement of the microbiome and metabolome, and flexible sigmoidoscopy to obtain mucosal biopsies before and after the dietary supplementation.

Monitoring During the Clinical Trial: This will follow the scheme laid out on Figure 7. On day 0, participants will visit the clinic and will be asked to save their first fecal sample using our standard operating procedure developed and proven to be effective in our last study. They will then be given their first supplement drink made up in their vehicle of choice, and taken with a standard meal provided by the diet kitchen. During the trial, they will be instructed on the use of a simple diary to be completed at home. This will record the major food items consumed each day, the timing and completion of drink supplements, as well as the bowel function questionnaire to assess daily GI tolerance, i.e. abdominal discomfort, distension, gas, bowel frequency, nausea, vomiting. They will be asked to return to the clinic for a follow-up appointment on day 7, 14 and 21 in order to repeat the fecal and breath tests described above. At the same time, body weight will be monitored using one scale. At the end of 4 weeks, participants will be asked to return to the clinic for repeat of the colonic sampling performed at baseline.

similar packets, similar appearing supplements

Fiber to Reduce Colon Cancer in Alaska Native People

Randomized Controlled Trial of Resistant Starch to Reduce Colon Cancer Risk in Alaska Native People.

we will use a public deposit when all the data analysis is completed

fecal and colonic conjugated bile acid analysis

Alaska Native Tribal Health Consortium

University of Pittsburgh

Rectal Diseases

12g Maltodextrin and 23g Amioca starch daily in divided doses for 50 days. Provided as a powder to be added to food or drink.

Maltodextrin and Amioca starch

23g Hi-maize 260 and 12g Maltodextrin daily in divided doses for 50 days. Provided as a powder to be added to food or drink.

Hi-maize 260

12g polydextrose and 23g amioca starch daily in divided doses for 50 days. Provided as a powder to be added to food or drink.

Polydextrose

12g polydextrose and 23g Hi-maize 260 daily in divided doses for 50 days. Provided as a powder to be added to food or drink.

Hi-maize 260 and polydextrose

John Mathers, PhD

Naomi Willis, PhD

Colorectal cancer is a common disease worldwide. It is now thought that colorectal cancer cells arise from stem cells where the genetic material regulating growth and division of the stem cell has become defective. This leads to unregulated production of cells which in turn have defective genetic information and cancer formation.

Research into colorectal cancer is hampered by the fact that studies must take a very long time to produce results and be very large if the development of a cancer is the endpoint. Therefore alternative methods of quantifying the risk of developing a cancer are required so trials can be a realistic size and be completed in a realistic time frame. The investigators have previously identified several candidates for these 'biomarkers'. The next stage in proving or disproving these as useful biomarkers is to test their response to a dietary agent that the investigators know reduces the risk of colon cancer.

This project is designed to enhance understanding of links between food and the health of the gut. The particular purpose of the project is to investigate the impact of a well-defined intervention in human volunteers on a panel of novel, and established, diet-related biomarkers of bowel cancer risk. We have developed a number of novel biomarkers of diet-related CRC risk measured in colo-rectal mucosal biopsies (and in stool). These biomarkers include differentially expressed proteins, DNA methylation markers and inflammation markers. In our on-going BORICC Study we are investigating the relationships between dietary exposure and nutritional status for these biomarkers in a cross-sectional study. The next logical step in this research is to determine whether a selected panel of the most promising biomarkers responds to a dietary intervention i.e. to test their utility as biomarkers of GI health and potential as surrogate endpoints in future human studies.

We propose to use Hi-maize 260 and polydextrose (PD) as our model resistant starch (RS) intervention agents. RS describes the fraction of dietary starch which is not digested in the small bowel and which flows to the colon where it is a substrate for bacterial fermentation. (Asp, 1996) PD is produced by the bulk melt polycondensation of glucose and sorbitol to produce an oligosaccharide with a mean degree of polymerisation of 12 which is resistant to mammalian GI enzymes and, like other RSs, is a substrate for bacterial fermentation. (Auerbach, 2007) Both Hi-maize and PD are fermented (to a greater or lesser extent) producing short-chain fatty acids (SCFA) including butyrate. (Asp, 1996) Butyrate has beneficial effects on gut physiology and immune function including anti-inflammatory effects. (Wächtershäuser, 2000; Dronamraju, 2009)

In the present project we will investigate the impact of PD and RS, as food-borne substrates for delivery of butyrate, on biomarkers of bowel cancer risk.

Chemoprevention of Colorectal Cancer: the Role of Non-digestible Carbohydrates

Northumbria Healthcare NHS Foundation Trust

Newcastle University

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Diabetes Mellitus

Diabetes Mellitus, Type 2

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Hypoglycemic Agents

Insulin

Insulin, Globin Zinc

Bagels made from high-resistant starch flour (provides 24g resistant starch per day)

In a randomized crossover fashion, participants will consume bagels that are made with either high-resistant starch or standard wheat flour, daily for a period of 8 weeks, with a 4 week washout period.

Alison M Duncan, Ph.D., R.D.

The purpose of this study is to determine if consumption of bagels made with resistant starch for 8 weeks can improve markers of type 2 diabetes, colon cancer and satiety in adults.

Using a randomized, double-blind crossover study design, we will determine the effect of consuming bagels made with resistant starch daily for 8-weeks can reduce the risk of type 2 diabetes and colon cancer in an adults who are at an increased risk for type 2 diabetes. Additionally, we will compare the satiating effect of these bagels to that of a standard bagel.

The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer

Human Clinical Trial to Investigate the Effects of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer in Adults at Risk for Type 2 Diabetes

Questionnaires will be used to measure the participants' responses to the aroma, appearance, taste and texture of the study bagels.

Questionnaires about bagel tolerance, including subjective ratings of tolerance and any adverse events will be completed every 2 weeks throughout both treatment periods (adverse events will be recorded as often as needed).

Body weight will be measures at every study visit.

Total-cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides will be measured from fasted blood samples on days 1 and 57 of both treatment periods.

Participants will complete 3-day food records a total of 3 times throughout the study to provide information about their background nutrient intake and dietary habits.

Blood glucose will be measured in the fasting state and postprandially (during a 3-hour oral glucose tolerance test) on the first and last study days of both treatment periods.

Circulating insulin will be measured in the fasting state and postprandially (during a 3-hour oral glucose tolerance test) on the first and last study days of both treatment periods.

HbA1c (glycated haemoglobin) will be measured from fasting blood drawn on days 1 and 57 of both treatment periods.

Data will be used from 3-hour oral glucose tolerance tests performed on days 1 and 57 of both treatment periods.

After study bagel consumption as part of a standard breakfast, questionnaires will be used to quantify subjective measures of satiety, and weighted food records will be used to objectively measure food intake for the rest of the day.

Ontario Ministry of Agriculture, Food and Rural Affairs

Maple Leaf Foods, Canada Bread

University of Guelph

Alison Duncan, Ph.D., R.D., Professor

Adenocarcinoma

Patients eat a diet consisting of resistant starch foods daily for 8 weeks.

Patients eat a diet consisting of regular corn starch foods daily for 8 weeks.

Dietary Intervention (resistant starch)

Dietary Intervention (regular starch)

Questionnaire Administration

Marian Neuhouser

This phase II, randomized pilot trial studies the effect of the consumption of foods made with resistant starch compared to foods made with corn starch on biomarkers that may be related to colorectal cancer progression in stage I-III colorectal cancer survivors. Foods made with resistant starch may beneficially influence markers of inflammation, insulin resistance, and the composition of gut bacteria in colorectal cancer survivors.

Participants are randomized to 1 of 2 groups.

GROUP I (INTERVENTION GROUP): Participants eat a diet consisting of resistant starch foods daily for 8 weeks. Study provided foods are in addition to their own usual daily diet.

GROUP II (CONTROL GROUP): Participants eat a diet consisting of regular corn starch foods daily for 8 weeks. Study provided foods are in addition to their own usual daily diet.

Blinded, block randomization based on sex and BMI.

Assignment to the active versus control group will be blinded using a computer program and will be designated as "diet A" and "diet B". Investigators will be unblinded once the study and data analyses have been completed.

Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors

Randomized, Controlled Trial of Resistant Starch in Stage I-Ill Colorectal Cancer Survivors Pilot Study: The Fiber for Health After Cancer Study

The accrual rate will be estimated with number of participants at full enrollment at 12 months.

The adherence endpoint pertains to adherence to the intervention and is defined as consuming 75% or more of study foods on 75% of days from baseline to 8 weeks.

The retention endpoint is defined as at least 80% of enrolled participants providing blood and stool samples at the week 8 timepoint.

Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.

CRP was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.

This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in alpha diversity and genera in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes int he microbiome in response to the intervention.

This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in global microbial community (beta diversity) in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes in the microbiome in response to the intervention.

National Cancer Institute (NCI)

Fred Hutchinson Cancer Center

Professor

Method of assessment: weekly participant-completed questionnaire. The number of participants (n=7) analyzed for adverse events ("number at risk" below) is fewer than the number enrolled (n=10) because 3 participants withdrew consent prior to starting the intervention.

Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.

1-Active (Resistant Starch)

Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.

2-Control (Regular Starch)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Height

Weight

Body Mass Index (BMI)

BMI Category

Participants were staged clinically by the interdisciplinary clinical oncology team per American Joint Committee on Cancer Staging Criteria for colorectal carcinoma (AJCC 8th edition). AJCC Stage Groupings I-III for colorectal carcinoma were eligible for the trial. Prognostic outcomes are considered better for lower stages and worse for higher stages.

T-stage

N-stage

Marian L. Neuhouser, PhD

Feasibility: Accrual

Overall number of participants analyzed for the adherence measure: 7 (per protocol)

Feasibility: Adherence

All participants enrolled, in accordance with protocol and Statistical Analysis Plan

Feasibility: Retention

Adiponectin - baseline

Adiponectin - followup

Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 follow-up timepoints on just 5 participants.

Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)

C-reactive protein - baseline

C-reactive protein - followup

Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 followup timepoints on just 5 participants.

Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP)

Alpha diversity - baseline

Alpha diversity - first follow-up (week 2)

Alpha diversity - second follow-up (week 8)

Faecalibacterium Prausnitzii - baseline

Faecalibacterium Prausnitzii - first follow-up (week 2)

Faecalibacterium Prausnitzii - second follow-up (week 8)

Akkermansia mucinipiila - baseline

Akkermansia mucinipiila - first follow-up (week 2)

Akkermansia mucinipiila - second follow-up (week 8)

Of the 10 participants enrolled to this study, fecal samples were collected at baseline and followup for 7 participants. Of these 7 participants, one participant on Arm 1 dropped out of the study after week 2 hence the week 8 followup fecal was not obtained. For the remaining 6 participants, fecal samples from all three time-points were analyzed.

Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA

Analysis limitation: due to low participant recruitment, there was insufficient number of stool samples available to detect and compute beta diversity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation	NCT05135351	Multiple Myelom... Lymphoma	Resistant Starc... Maltodextrin	19 Years -	University of Nebraska
Fiber to Reduce Colon Cancer in Alaska Native People	NCT03028831	Colon Cancer	70g of fully di... Resistant starc...	40 Years - 70 Years	University of Pittsburgh
Chemoprevention of Colorectal Cancer: the Role of Non-digestible Carbohydrates	NCT01214681	Colorectal Canc...	Maltodextrin an... Hi-maize 260 Polydextrose Hi-maize 260 an...	16 Years - 85 Years	Newcastle University
The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer	NCT02129946	Type 2 Diabetes...	Resistant Starc...	40 Years -	University of Guelph
Chemoprevention of Colorectal Cancer: the Role of Non-digestible Carbohydrates	NCT01214681	Colorectal Canc...	Maltodextrin an... Hi-maize 260 Polydextrose Hi-maize 260 an...	16 Years - 85 Years	Newcastle University
Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors	NCT03781778	Colon Cancer Rectal Cancer Cancer Survivor Colorectal Aden... Stage I Colorec... Stage II Colore... Stage IIA Color... Stage IIB Color... Stage IIC Color... Stage III Color... Stage IIIA Colo... Stage IIIB Colo... Stage IIIC Colo...	Dietary Interve... Dietary Interve... Questionnaire A...	18 Years -	Fred Hutchinson Cancer Center
The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer	NCT02129946	Type 2 Diabetes...	Resistant Starc...	40 Years -	University of Guelph
The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer	NCT02129946	Type 2 Diabetes...	Resistant Starc...	40 Years -	University of Guelph
Chemoprevention of Colorectal Cancer: the Role of Non-digestible Carbohydrates	NCT01214681	Colorectal Canc...	Maltodextrin an... Hi-maize 260 Polydextrose Hi-maize 260 an...	16 Years - 85 Years	Newcastle University
Chemoprevention of Colorectal Cancer: the Role of Non-digestible Carbohydrates	NCT01214681	Colorectal Canc...	Maltodextrin an... Hi-maize 260 Polydextrose Hi-maize 260 an...	16 Years - 85 Years	Newcastle University

Spots Global Cancer Trial Database for resistant starch