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Effects of High Protein Diet on the Large Intestine in Overweight Humans

NCT02351297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-01-21

No results posted yet for this study

Summary

This study aims at evaluating the consequences of a 3 weeks high protein diet on the large intestine ecosystem (microbiota, metabolites and gene expression in rectal mucosa). Those parameters will be analysed with technics including OMICs methods. After a run-in period, 42 volunteers will receive either soy or milk protein or maltodextrin as a placebo control. This trial is double blind randomized placebo-controlled paralleled design (3 arms). Longitudinal sampling will allow the comparison of parameters during the study.

Conditions

Interventions

DIETARY_SUPPLEMENT

casein supplementation

After the run-in period, volunteers will receive casein supplementation (15 % of energy intake) for 3 weeks.

DIETARY_SUPPLEMENT

soy protein supplementation

After the run-in period, volunteers will receive soy protein supplementation (15 % of energy intake) for 3 weeks.

DIETARY_SUPPLEMENT

maltodextrin supplementation

After the run-in period, volunteers will receive maltodextrin supplementation (15 % of energy intake) for 3 weeks.

Sponsors & Collaborators

  • Hospital Avicenne

    lead OTHER

Principal Investigators

  • Robert BENAMOUZIG, MD PhD · Avicenne Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-05-31
Completion
2015-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02351297 on ClinicalTrials.gov