Neoplasms

All Conditions

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Digestive System Diseases

Carcinoma

Weight Loss

Obesity

Body Weight

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.

Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.

about 1 1/2 cups of legumes included in lunch and dinner meals

Legume diet group

Control diet group

to assess how long food takes to pass through the digestive system

Smartpill

legumes

Terry J Hartman, PhD, MPH, RD

This pilot study is designed to test the effects of a high legume (dried bean) diet on hunger and other indicators of health over the course of eight weeks, compared to a more conventional healthy diet.

The goal of the currently proposed study is to conduct a randomized controlled feeding pilot study within a more diverse population also at high risk for colorectal carcinoma (CRC) to evaluate whether a high-legume diet will result in increased satiety and in turn will facilitate reduced energy intake and weight loss compared to a control diet provided under similar conditions. In addition, explore potential beneficial effects of the high-legume diet on gastric emptying and circulating levels of appetite-regulating hormones and other biomarkers. Dietary behaviors that are even moderately more satiating over time have the potential to enhance weight loss and could lead to a significant public health impact among populations at high risk for colorectal carcinoma (CRC) and other chronic diseases.

Towards the end of the study, the participants will do an additional test, looking at how long food takes to pass through the digestive system using a SmartPill capsule. The SmartPill is a pill about the size of a large multivitamin that can measure pH, pressure, and temperature changes, which it uses to assess where in the digestive tract it is. The participant swallows the pill, and carries around a receiver that is about the size of a deck of cards for the next 3-5 days. The SmartPill is expelled, and the receiver notifies the participant that they can return the receiver to the study personnel.

Legume Diet Satiety Pilot Study

Legume Diet Satiety and Weight Loss Pilot Study

Evaluate the effects of a high-legume diet compared to a control diet with a similar macronutrient profile on weight change in a randomized controlled feeding study.

Compare the effects of the high-legume and control diets on gastric emptying time

Compare the effects of the high-legume and control diets on plasma insulin level in a meal response time (30 min) course experiment.

Compare the effects of the high-legume and control diets on self-reported dietary intake measured by telephone 24-hour dietary recalls.

Use self-reported satiety questionnaire to compare short-term responses to test meals.

Emory University

Terry Hartman PhD, MPH, RD

Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.

Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals

Smartpill: to assess how long food takes to pass through the digestive system

legumes: about 1 1/2 cups of legumes included in lunch and dinner meals

Legume Diet Group

Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.

Control diet group: no legumes in lunch or dinner meals

Smartpill: to assess how long food takes to pass through the digestive system

Control Diet Group

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Hartman, Terry Professor, SPH Epidemiology

Change in Weight

Gastric Emptying Time

Change in Plasma Insulin Level (Biomarker of Appetite Regulation)

Data were collected but not analyzed due to a lack of funding.

Energy Intake

Satiety

Overall Study

Gland and Hormone Related Diseases

Rare Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Chronic Disease

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Chronic Graft Versus Host Disease

A diet supplemented with 760 g of cooked and boneless red meat per week, corresponding the average consumption of red meat in Finnish men.

A diet supplemented with legume-based foods providing 20% of protein intake and with 200 g per week of red meat providing 5% of protein intake.

560 g of cooked and boneless red meat is replaced with legume-based foods providing the equal amount of protein.

Partial replacement of red meat with legume-based foods

Anne-Maria Pajari, PhD

The aim of this study is to investigate the effects of partial replacement of red meat with legume-based foods on gut metabolism and markers for colorectal cancer as well as markers for cardiovascular diseases and type 2 diabetes in healthy working age men. The study participants will be stratified into two groups with different amounts of red meat in diet: 1) a diet containing 760 g of cooked and boneless red meat, supplying 25% of daily protein intake and 2) a diet supplying 20% of protein intake with legume-based foods and 5% of protein intake with red meat. The participants will get all meat and and legume-based foods from the research center; otherwise they will be asked to follow their habitual diet. Blood, urine, and stool samples will be collected at the baseline and at the end of the 6 week intervention, as well as BMI, blood pressure and body composition. Nutrient intake and food consumption will be analyzed from 4-day food records at the baseline and at the end of the intervention period.

A human intervention study with healthy volunteers will be carried out to investigate the effects of partial replacement of red meat with legume-based foods on gut metabolism and markers for colorectal cancer as well as biomarkers for cardiovascular diseases and type 2 diabetes.

The study will be done in parallel-design, randomized fashion, with healthy male volunteers aged 20-65 years. Inclusion and exclusion criteria are described elsewhere. Duration of the intervention will be 6 weeks.

Intervention groups will be as follows (n=50/group):

Group 1: The habitual diet of participants is supplemented with 760 g of cooked and boneless red meat per week, representing the average meat consumption of Finnish men and supplying 25% of protein intake.

Group 2: The habitual diet of participants is supplemented with legume-based foods providing equal amount of protein as 560 g of red meat and 200 g of red meat per week.

The consumption of red meat and legumes will be kept stable throughout the intervention and participants are advised to avoid consuming any red meat or legumes in addition to those provided from the research center. The investigators also aim to investigate, whether replacing red meat with legumes induces other changes in diet. This information is be important if increasing legume consumption is recommended at the population level.

Before starting the intervention, participants will get dietary advice how to follow their diets. They will get the red meat and legume-based foods for free to help to implement the diets and to enhance compliance.

Blood, urine and fecal samples will be collected at the baseline and at the end of the intervention. Nutrient intake and food consumption during the intervention will be analyzed from 4-day food records at the baseline and at the end. Nutrient intakes will be calculated using a new Finnish 'Aromi' software.

The following data collection and analyses will be carried out at the baseline and at the end of the intervention period:

* height, weight, waist and hip circumferences
* body composition by bioelectrical impedance analysis
* resting blood pressure
* fasting lipid profile in the plasma (total cholesterol, LDL and HDL, triglycerides)
* fasting glucose and insulin, HbA1c in the blood
* high sensitive C-reactive protein
* markers for nutritional status in plasma/serum: hemoglobin, transferrin receptor, ferritin, vitamin B12, folate, vitamin D
* urea/nitrogen in the urine
* total and heme-based N-nitroso compounds in feces, concentrations of bile acids, gut microbiota

Red meat consumption exceeds the recommendation in 76% of Finnish men, while only 26% of Finnish women eat red meat more than the recommended maximum of 500 g per week. Decreasing meat consumption and replacing meat with legumes would be particularly important and relevant in men.

Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life)

Effects of Replacing Red and Processed Meat With Legume-based Foods on Nutrient Intake, Nutritional Status, Food Consumption, and Biomarkers of Cardiovascular Diseases, Colorectal Cancer, and Type 2 Diabetes in Healthy Working Age Men

The data collected is confidential and cannot be shared.

The composition of gut microbiota is measured using HITChip phylogenetic microarray.

The changes in the concentrations of total, LDL, and HDL cholesterol as well as plasma triglycerides.

The changes in the markers for nutritional status in plasma/serum: hemoglobin, transferrin receptor, ferritin, vitamin B12, folate. The intake of nutrients is calculated from 4-day food records.

The changes in gut microbiota are analyzed as a measure of diet modification.

University of Helsinki

Adjunct Professor

Colonic Neoplasms

Overweight

Overnutrition

Nutrition Disorders

Herbal and Botanical

All Drugs and Chemicals

Cola

Participants randomized to the high fiber diet featuring legumes (HLD) will add approximately 30 grams of dietary fiber per day from legume dishes, ensuring a total intake of approximately 50 grams of dietary fiber per day.

Participants randomized to the healthy American diet control arm will receive pre-portioned meal replacement entrées with legumes replaced by lean chicken or meat.

The high fiber diet featuring legumes (HLD) provides pre-portioned entrées for two meals per day in months 1-3, and one meal per day in months 4-6. Participants continue on the diet in months 7-12 but assume responsibility for food preparation. The HLD will contain approximately 250 grams (g) of legumes per day (\~1 ½ cups cooked legumes) in months 1-3 provided in two pre-portioned single serving entrées (i.e. \~125g in each serving). A study nutritionist provides in-person and written guidance for including side dishes that are nutritionally balanced with energy intake to lose 1-2 pounds of weight per week.

High Fiber Diet Featuring Legumes (HLD)

The healthy American diet provides pre-portioned meal replacement entrées with legumes replaced by lean chicken or meat. Participants continue on the diet in months 7-12 but assume responsibility for food preparation. A study nutritionist provides in-person and written guidance for including side dishes that are nutritionally balanced with energy intake to lose 1-2 pounds of weight per week.

Healthy American Diet

Terry Hartman, PhD, MPH, RD

Terry Hartman, PHD, MPH

This study tests whether a high-fiber diet based on legumes, such as dry beans, can lead to sustained reductions in obesity and colon cancer risk in persons at highest risk, namely overweight or obese, post-polypectomy patients.

An important knowledge gap concerns the role of fiber in sustaining reduced energy intake to simultaneously manage weight and influence human colorectal cancer risk. Epidemiologic studies have shown an association between a high fiber diet featuring legumes (HLD) and reduced obesity and lower risk for adenoma recurrence or colorectal cancer. There are many plausible mechanisms to explain why high-fiber diets, and especially a HLD, may reduce colorectal cancer risk. First, fiber is fermented by the colonic microbiota to produce short chain fatty acids (SCFA). The SCFA, butyrate, has a remarkable array of colonic mucosal health promoting, anti-inflammatory, and anti-neoplastic properties. Secondly, microbiota break down plant cell walls releasing phytochemicals, which also have powerful anti-inflammatory and anti-carcinogenic effects. Thirdly, colonic transit is accelerated, reducing contact time with luminal carcinogens, such as heterocyclic amines formed from cooked red meat, and secondary bile acids, induced by a high fat diet and synthesized by the colonic microbiota.

Dr. Stephen O'Keefe's lab performed a human randomized controlled crossover feeding study (participants receive both diets) comparing high and low- fiber diets. The study measured mucosal biomarkers of cancer risk (proliferation - % epithelial cells staining positive for Ki67, inflammation - cluster of differentiation 3 (CD3)+ intraepithelial lymphocytes, cluster of differentiation 68 (CD68)+ lamina propria macrophages) made by fecal sampling and colonoscopy. Results suggested that within weeks these markers responded favorably to the high-fiber diet with proliferative rates and inflammatory biomarkers decreasing and microbiota composition adapting to increase butyrogenesis.

The researchers of this study have previously found that fiber may also reduce cancer risk indirectly by promoting weight loss, improving insulin sensitivity and decreasing inflammation. On average, individuals consume a similar weight of food daily; thus, replacing energy dense foods (higher kcal/g, e.g., high fat) with lower energy density foods (lower kcal/g), like legumes, should potentiate weight control. Viscous fiber intake is associated with longer gastric emptying times which over time might contribute to postponing the next eating occasion. Diet may also induce changes in gut microbiome composition leading to negative energy balance. Emerging human evidence links the gut microbiome with insulin resistance, inflammation, and obesity and with adenomatous polyps and colon cancer. In this current study, characterizing gut motility, microbiome, and metabolome composition profiles that may influence weight loss and have a role in the prevention or recurrence of adenomas and colorectal cancer, will provide novel and potentially therapeutic information.

The goal of the research is to conduct a clinical trial featuring study-provided pre-portioned entrées and strategic nutritional instruction to guide participants to integrate legumes into a healthy high-fiber diet pattern. Participants will be provided two entrées per day during months 1 through 3, and one entrée per day during months 4 through 6. Participants will continue their diets during months 7 through 12 but will be responsible for food preparation. The research will target a population at high risk for colorectal cancer, overweight and obese participants with a history of a colon polyp in the past 3 years, to test whether a high-legume, high-fiber diet will simultaneously increase weight loss and suppress intestinal biomarkers of cancer risk compared to a control diet (healthy American). In addition, it will explore potential mechanisms through which the high-legume intervention diet facilitates weight loss and intestinal health.

Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer

De-identified participant phenotypic data will be made available for sharing but limited to health/biomedical purposes including age, obesity status, presence of colon polyps and history of diabetes. The data will be coded and only the coded data set, and not the master list, will be shared.

Participants will have their body weight measured (in pounds) on a regularly calibrated digital scale while wearing light clothing without shoes.

Colonic mucosal proliferative biomarker Ki-67+ will be measured.

Colonic mucosal proliferative biomarker Ki-67+ will be measured

Gut transit time is assessed using an indigestible single-use SmartPill capsule, a receiver, and display software. The SmartPill capsules were discontinued and no longer available after 2023 so participants beginning after January 19, 2024 will not complete this assessment.

Fasting plasma insulin, a biomarker of insulin resistance is measured by blood test.

Fasting plasma glucose, a biomarker of insulin resistance, is measured by blood test.

Serum C-reactive protein, an indicator of systemic inflammation, is measured by blood test.

CD3+ intraepithelial lymphocytes, a colonic mucosal inflammatory biomarker of colon cancer risk, will be measured by mucosal biopsy.

CD68+ lamina propia macrophages, a colonic mucosal inflammatory biomarker of colon cancer risk, will be measured by mucosal biopsy.

National Cancer Institute (NCI)

Professor

Common Bean

Randomized participants consume 1 meal and 1 snack per day that does not include either rice bran or navy bean powder for 28 days.

Randomized participants consume 1 meal and 1 snack per day containing cooked navy bean powder (35 g/day) for 28 days.

Randomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days.

Placebo-Control Meals and Snacks

Cooked Navy Bean Powder Meals and Snacks

Rice Bran Meals and Snacks

Elizabeth P Ryan, PhD

The purpose of this study is to explore the effects of cooked navy bean powder or rice bran consumption on the stool microbiome and metabolome of colorectal cancer survivors and healthy adults.

Objectives:

1. To learn about how increased cooked navy bean powders or rice bran dietary intake affect the stool microbiota of colorectal cancer survivors and healthy adults.
2. To determine whether cooked navy bean powders or rice bran consumption modulate microbial metabolism.
3. To observe dietary changes in the blood, urine and stool metabolite profiles and inflammatory cytokines.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Legume Diet Satiety Pilot Study	NCT02269631	Obesity Colorectal Carc...	Legume diet gro... Control diet gr... Smartpill legumes	40 Years - 70 Years	Emory University
Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life)	NCT04599920	Colorectal Canc... Cardiovascular ... Type2 Diabetes	Partial replace...	20 Years - 65 Years	University of Helsinki
Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer	NCT04780477	Colon Cancer Obesity	High Fiber Diet... Healthy America...	40 Years - 75 Years	Emory University
Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial	NCT01929122	Colorectal Canc...	Placebo-Control... Cooked Navy Bea... Rice Bran Meals...	18 Years -	Colorado State University
Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial	NCT01929122	Colorectal Canc...	Placebo-Control... Cooked Navy Bea... Rice Bran Meals...	18 Years -	Colorado State University

Spots Global Cancer Trial Database for legumes

Every month we try and update this database with for legumes cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for legumes

Every month we try and update this database with for legumes cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for legumes cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.