Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasms

Inflammation

Colitis

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Pomegranate

Raspberry

Cola

Strawberry

English Walnut

Blackberry

Following enrollment, participants will start a 7-day wash-out period where they will be asked to avoid foods and beverages high in ellagitannins. These include pomegranates, hazelnuts, pistachios, walnuts (besides the samples given by the researchers), strawberries, raspberries, blackberries, oak-aged wines and spirits; a full list of foods and beverages to avoid will be provided. Then, participants will consume 2 ounces of walnuts daily with their usual diet while continuing to avoid ellagitannins for 21 days prior to their routine colonoscopy.

Participants consume 2 ounces of walnuts daily for 21 days

Walnuts

Nuoxi Fan

Slawa Gajewska

Daniel W. Rosenberg, Ph.D.

John W. Birk, M.D.

Haleh Vaziri, M.D.

Thalia Matos

Steven M. Lipkin, M.D., Ph.D.

Felice Schnoll-Sussman, M.D.

The purpose of this research study is to examine whether adding walnuts to your diet can have a beneficial effect on the gut bacteria population, inflammatory markers in the blood, and the tissue that lines the inside of the colon.

This is a 29-day dietary intervention study where participants will be asked to consume 2 ounces of walnuts daily for 21 days, and at the end of the study period they will come in for a routine colonoscopy. After being informed about the study and potential risks, participants giving written informed consent will first start a 7-day wash-out period where they will be asked to avoid foods high in ellagitannins for the duration of the study. In addition, participants will be asked to complete food and activity questionnaires, a walnut consumption log, and two sets of 3-day dietary records during their participation in the study. Participants will also be asked to provide three urine samples, two blood samples, and two stool samples at multiple time points, and 8-10 colon tissue specimens (biopsies) will be collected during their colonoscopy procedure for the purposes of this study.

Walnuts and Colon Health

Microbiota, Metabolites and Colon Neoplasia

Bacterial composition and taxonomy changes in the fecal microbiome will be assessed using 16 Svedberg unit (16S) ribosomal ribonucleic acid (rRNA) sequencing, at day 7 (post-washout/pre-walnut supplementation) and at day 28 (post-walnut supplementation).

Bacterial diversity/abundance changes and strain-level variations in the fecal microbiome will be assessed using metagenomic shotgun sequencing at day 7 (post-washout/pre-walnut supplementation) and at day 28 (post-walnut supplementation).

Bacterial gene expression profile changes in the fecal microbiome will be assessed using metagenomic ribonucleic acid (RNA) sequencing at day 7 (post-washout/pre-walnut supplementation) and at day 28 (post-walnut supplementation).

Urolithin levels will be measured in urine by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry at day 0 (baseline/pre-washout), day 7 (post-washout/pre-walnut supplementation) and day 29 (post-walnut supplementation/end of study).

Baseline urolithin levels measured in the urine by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry will be associated with the presence (and type) of colonic lesions (e.g., advanced adenomas (AAs) or sessile serrated adenoma/polyps (SSA/Ps)) detected during the colonoscopy procedure at the end of the study (day 29).

Detailed statistical analyses will be used to correlate urolithin formation with the composition of the fecal microbiome at day 7 (post-washout/pre-walnut supplementation) and at day 28 (post-walnut supplementation).

Colonic lesion (AAs and SSA/Ps) biopsies obtained at the end of the study (day 29) during the colonoscopy procedure will undergo DNA sequence-based analysis to determine gene expression profiling. These results will be compared to urinary urolithin levels measured at baseline to establish correlations between urolithin production and colorectal cancer risk markers.

Short-chain fatty acids in freeze-dried stool samples will be measured using differential mobility separation at day 7 (post-washout/pre-walnut supplementation) and at day 28 (post-walnut supplementation).

Primary and secondary bile acids in freeze-dried stool samples will be analyzed using standard liquid chromatography-mass spectrometry methods at day 7 (post-washout/pre-walnut supplementation) and at day 28 (post-walnut supplementation).

Markers of systemic inflammation associated with adenoma risk will be measured in plasma using commercial enzyme-linked immunoassay (ELISA) kits at day 7 (post-washout/pre-walnut supplementation) and at day 29 (end of study).

Overall diet quality and habits documented on brief food questionnaires will be analyzed by NutritionQuest at day 7 (post-washout/pre-walnut supplementation). Dietary behavior data will be correlated with the presence or absence of colonic polyps detected during the colonoscopy procedure at the end of the study (day 29).

Dietary behavior data documented on 3-day dietary records will be analyzed by Nutrition Data System for Research software. This data will be correlated with fecal microbiome composition and diversity at day 7 (post-washout/pre-walnut supplementation) and at day 28 (post-walnut supplementation).

Dietary behavior data documented on 3-day dietary records will be analyzed by Nutrition Data System for Research software. This data will be correlated with urolithin levels at day 7 (post-washout/pre-walnut supplementation) and at day 28 (post-walnut supplementation).

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Weill Medical College of Cornell University

University of Connecticut

California Walnut Commission

Spanish National Research Council

University of Florida

UConn Health

Professor of Medicine

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Syndrome

Polycystic Ovary Syndrome

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

Insulin

Insulin, Globin Zinc

Patients will be randomized to receive walnuts

Patients will be randomized to receive almonds

Subjects will follow their usual diet for 4 weeks; after that they will be randomized to walnuts. They will eat walnuts once daily for six weeks.

walnuts

Subjects will follow their usual diet for 4 weeks; after that they will be randomized to almonds. They will eat almonds once daily for six weeks.

almonds

Sidika E Kasim-Karakas, MD

The purpose of this study is to learn more about the effects of walnuts, walnut-oil, almonds and fish oils on blood sugar and insulin levels in polycystic ovary syndrome (PCOS) patients. The hypothesis is that a diet rich in these foods will improve insulin resistance in women with PCOS.

Polycystic ovary syndrome is a common disease that affects 1 out of 16 women. Metabolic and endocrine abnormalities seen in PCOS include insulin resistance, androgen excess and infertility. This study focuses on the insulin resistance aspect because increased insulin resistance leads to premature onset of impaired glucose tolerance or diabetes whereas decreased insulin resistance reduces androgen excess, improves the ovarian function and increases fertility. Although insulin resistance can be treated with insulin-sensitizing drugs, PCOS clinically manifests during adolescence and the long-term safety of the drug-treatment can be a concern. Thus, improving insulin resistance with effective nutritional approaches would be very desirable. Epidemiological studies and animal experiments suggest that replacement of dietary saturated fats with monounsaturated (MUFA) and polyunsaturated (PUFA) fats improves insulin resistance.

The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome

Walnuts, Walnut-Oil, Glucose Homeostasis, PCOS

National Center for Complementary and Integrative Health (NCCIH)

University of California, Davis

Adenocarcinoma

Prostatic Neoplasms

Body Weight

Weight Loss

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Body Weight Changes

Other Dietary Supplements

Omega 3 Fatty Acid

Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks

usual diet

phone counseling with dietitian

Yunhee Choi-Kuaea, MSW

Stephen Freedland, MD

Aubrey Jarman, RD

This is a randomized control trial testing the effect of walnut supplementation on prostate cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo RP. Patients consented to the study will be randomly assigned to either continue their usual diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their consent date and the date for RP.

The overall objective of this study is to test the effect of walnuts added to a usual diet on prostate cancer progression as measured by Ki67 expression in the prostate tissues. Subjects will be randomized 1:1 to usual diet or usual diet with the addition of 2 ounces of walnuts daily. The baseline visit will occur in conjunction with a standard of care visit post-biopsy, the intervention period will range from 4-10 weeks dependent upon the scheduled date of the standard of care radical prostatectomy (RP), and the final visit will occur in conjunction with a standard of care visit prior to RP.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Walnuts and Colon Health	NCT05195970	Colorectal Canc... Diet Habit	Walnuts	39 Years - 75 Years	UConn Health
The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome	NCT00579904	Polycystic Ovar... Insulin Resista...	walnuts almonds	18 Years - 45 Years	University of California, Davis
The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome	NCT00579904	Polycystic Ovar... Insulin Resista...	walnuts almonds	18 Years - 45 Years	University of California, Davis
WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy	NCT03824652	Prostate Cancer	walnuts usual diet phone counselin...	18 Years -	Cedars-Sinai Medical Center
The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome	NCT00579904	Polycystic Ovar... Insulin Resista...	walnuts almonds	18 Years - 45 Years	University of California, Davis
The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome	NCT00579904	Polycystic Ovar... Insulin Resista...	walnuts almonds	18 Years - 45 Years	University of California, Davis

Spots Global Cancer Trial Database for walnuts

Every month we try and update this database with for walnuts 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 walnuts

Every month we try and update this database with for walnuts 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 walnuts 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.