NCT02351297

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

January 20, 2015

Last Update Submit

January 20, 2016

Conditions

OverweightHealthy

Keywords

High protein dietMicrobiotaRectal biopsiesMetabolomicsBacterial metabolitesvolunteers

Outcome Measures

Primary Outcomes (1)

  • Change in gene expression in rectal biopsy from baseline after 3 week dietary intervention

    Gene expression in biopsies collected before (baseline) and after 3 week dietary intervention will be measured by transcriptomic analyses. Differential gene expression will be expressed as relative units (fold change).

    Change for baseline in gene expression in rectal biopsy after 3 weeks dietary intervention

Secondary Outcomes (2)

  • microbiota composition analysis

    Change for baseline in microbiota composition after 3 weeks dietary intervention

  • fecal water metabolomics

    Change for baseline in fecal water metabolites after 3 weeks dietary intervention

Study Arms (3)

Casein supplementation

EXPERIMENTAL

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

Dietary Supplement: casein supplementation

Soy protein supplementation

EXPERIMENTAL

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

Dietary Supplement: soy protein supplementation

Maltrodextrin supplementation

PLACEBO COMPARATOR

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

Dietary Supplement: maltodextrin supplementation

Interventions

casein supplementationDIETARY_SUPPLEMENT

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

Casein supplementation
soy protein supplementationDIETARY_SUPPLEMENT

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

Soy protein supplementation
maltodextrin supplementationDIETARY_SUPPLEMENT

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

Maltrodextrin supplementation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 25- 30
  • Body weight stable last 3 months
  • Moderate physical activity

You may not qualify if:

  • Abnormal food behavior
  • Digestive, renal, hepatic, pulmonary, hemostasis, neoplasic diseases
  • antibiotic, pre or probiotics use in the last 3 months
  • intolerance for the tested product
  • positive serology for infectious disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Beaumont M, Portune KJ, Steuer N, Lan A, Cerrudo V, Audebert M, Dumont F, Mancano G, Khodorova N, Andriamihaja M, Airinei G, Tome D, Benamouzig R, Davila AM, Claus SP, Sanz Y, Blachier F. Quantity and source of dietary protein influence metabolite production by gut microbiota and rectal mucosa gene expression: a randomized, parallel, double-blind trial in overweight humans. Am J Clin Nutr. 2017 Oct;106(4):1005-1019. doi: 10.3945/ajcn.117.158816. Epub 2017 Sep 13.

    PMID: 28903954DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert BENAMOUZIG, MD PhD

    Avicenne Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of gastroenterology department

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 30, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 21, 2016

Record last verified: 2016-01