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

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ClinicalTrials.gov Identifier: NCT02351297
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Robert Benamouzig, Hospital Avicenne

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.

Condition or disease Intervention/treatment Phase
Overweight Healthy Dietary Supplement: casein supplementation Dietary Supplement: soy protein supplementation Dietary Supplement: maltodextrin supplementation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of High Protein Diet on the Large Intestine in Overweight Humans
Study Start Date : January 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
Experimental: Casein supplementation
After the run-in period, volunteers will receive casein supplementation (15 % of energy intake) for 3 weeks.
Dietary Supplement: casein supplementation
After the run-in period, volunteers will receive casein supplementation (15 % of energy intake) for 3 weeks.

Experimental: Soy protein supplementation
After the run-in period, volunteers will receive soy protein 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.

Placebo Comparator: Maltrodextrin supplementation
After the run-in period, volunteers will receive maltodextrin 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.




Primary Outcome Measures :
  1. Change in gene expression in rectal biopsy from baseline after 3 week dietary intervention [ Time Frame: Change for baseline in gene expression in rectal biopsy after 3 weeks 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).


Secondary Outcome Measures :
  1. microbiota composition analysis [ Time Frame: Change for baseline in microbiota composition after 3 weeks dietary intervention ]
    Microbiota composition will be analysed in stool samples before (baseline) and after 3 week dietary intervention using metagenomic analyses and will be expressed as bacterial relative abundance.

  2. fecal water metabolomics [ Time Frame: Change for baseline in fecal water metabolites after 3 weeks dietary intervention ]
    Fecal water metabolites will be analysed in stool samples before (baseline) and after 3 week dietary intervention using RMN analyses and will be expressed as metabolites relative abundance.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351297


Sponsors and Collaborators
Hospital Avicenne
Investigators
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Principal Investigator: Robert BENAMOUZIG, MD PhD Avicenne Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Benamouzig, Head of gastroenterology department, Hospital Avicenne
ClinicalTrials.gov Identifier: NCT02351297    
Other Study ID Numbers: 2013-A01730-45
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Keywords provided by Robert Benamouzig, Hospital Avicenne:
High protein diet
Microbiota
Rectal biopsies
Metabolomics
Bacterial metabolites
volunteers
Additional relevant MeSH terms:
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Overweight
Body Weight
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action