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Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer trial study protocol: a randomised clinical trial of fibre-rich legumes targeting the gut microbiome, metabolome and gut transit time of overweight and obese patients with a history of noncancerous adenomatous polyps.

BMJ open
January 1, 1970
Terryl J Hartman et al. (13 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, N.I.H., ExtramuralHuman StudyClinical
Study Details

Study Goal

The researchers aimed to test whether a high-fibre diet featuring legumes (beans) could simultaneously facilitate weight reduction and suppress colonic mucosal biomarkers of colorectal cancer in overweight/obese adults with a history of colorectal polyps.

Results Summary

The abstract describes the study design but does not report results, as the study is ongoing.

Population

Overweight or obese adults with a history of noncancerous adenomatous polyps within the previous 3 years.

Effective Dosage

Preportioned high-fibre legume-rich entrées for two meals/day in months 1-3 and one meal/day in months 4-6.

Duration

6 months

Interactions

None mentioned

Extracted Claims (11)
InterventionDirectionEndpointPopulationDosageImpactClaim #
fibre-rich legumes, such as cooked dry beans
increase
metabolic health
-
-
support the beneficial effects
#1
fibre-rich legumes, such as cooked dry beans
decrease
cancer risk
-
-
support the beneficial effects
#2
high-fibre diet featuring legumes
decrease
weight reduction
participants with overweight/obesity and a history of colorectal polyps
-
will test whether... will simultaneously facilitate
#3
high-fibre diet featuring legumes
decrease
colonic mucosal biomarkers of colorectal cancer (CRC)
participants with overweight/obesity and a history of colorectal polyps
-
will test whether... will suppress
#4
high-fibre legume-rich entrées
decrease
body weight
overweight or obese adults with a history of noncancerous adenomatous polyps
-
designed to characterise changes in
#5
high-fibre legume-rich entrées
decrease
biomarkers of insulin resistance
overweight or obese adults with a history of noncancerous adenomatous polyps
-
designed to characterise changes in
#6
high-fibre legume-rich entrées
decrease
biomarkers of systemic inflammation
overweight or obese adults with a history of noncancerous adenomatous polyps
-
designed to characterise changes in
#7
high-fibre legume-rich entrées
increase
compositional and functional profiles of the faecal microbiome
overweight or obese adults with a history of noncancerous adenomatous polyps
-
designed to characterise changes in
#8
high-fibre legume-rich entrées
increase
compositional and functional profiles of the metabolome
overweight or obese adults with a history of noncancerous adenomatous polyps
-
designed to characterise changes in
#9
high-fibre legume-rich entrées
decrease
mucosal biomarkers of CRC risk
overweight or obese adults with a history of noncancerous adenomatous polyps
-
designed to characterise changes in
#10
high-fibre legume-rich entrées
increase
gut transit
overweight or obese adults with a history of noncancerous adenomatous polyps
-
designed to characterise changes in
#11
Abstract

INTRODUCTION: Recently published studies support the beneficial effects of consuming fibre-rich legumes, such as cooked dry beans, to improve metabolic health and reduce cancer risk. In participants with overweight/obesity and a history of colorectal polyps, the Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer randomised clinical trial will test whether a high-fibre diet featuring legumes will simultaneously facilitate weight reduction and suppress colonic mucosal biomarkers of colorectal cancer (CRC). METHODS/DESIGN: This study is designed to characterise changes in (1) body weight; (2) biomarkers of insulin resistance and systemic inflammation; (3) compositional and functional profiles of the faecal microbiome and metabolome; (4) mucosal biomarkers of CRC risk and (5) gut transit. Approximately 60 overweight or obese adults with a history of noncancerous adenomatous polyps within the previous 3 years will be recruited and randomised to one of two weight-loss diets. Following a 1-week run-in, participants in the intervention arm will receive preportioned high-fibre legume-rich entrées for two meals/day in months 1-3 and one meal/day in months 4-6. In the control arm, entrées will replace legumes with lean protein sources (eg, chicken). Both groups will receive in-person and written guidance to include nutritionally balanced sides with energy intake to lose 1-2 pounds per week. ETHICS AND DISSEMINATION: The National Institutes of Health fund this ongoing 5-year study through a National Cancer Institute grant (5R01CA245063) awarded to Emory University with a subaward to the University of Pittsburgh. The study protocol was approved by the Emory Institutional Review Board (IRB approval number: 00000563). TRIAL REGISTRATION NUMBER: NCT04780477.

Medical Subject Headings (MeSH)
AdultHumansOverweightGastrointestinal MicrobiomeFabaceaeObesityColonic NeoplasmsAdenomatous PolypsVegetablesMetabolomeBiomarkersRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Quality85/10
Citation Metrics
Total Citations4
Citations/Year4.0
Research Impact Scores
APT Score0.75
Weight Score1.61
Normalized Score0.57
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