Gut Microbiota and Proteins Intake

• Register: ClinicalTrials.gov
• Last refreshed on: 28 April 2015
• Main ID: NCT02223585
• Date of registration: 21/08/2014
• Prospective Registration: Yes
• Primary sponsor: Nestlé
• Public title: Gut Microbiota and Proteins Intake
• Scientific title: Gut Microbial Response to Well-balanced Diet With Emphasis on Animal or Vegan Protein
• Date of first enrolment: October 2014
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02223585
• Study type: Interventional
• Study design: Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Maurice Beaumont, MD, PhD, PD Dr
• Affiliation: Metabolic Unit, Clinical Development Unit, Nestec

Key inclusion & exclusion criteria

Inclusion Criteria:

- Caucasian

- Regular bowl movement (at least once every 1-2 days)

- Between 18 and 55 years old

- BMI between 18.5 and 27 kg/m2 (inclusive)

- Willing and able to sign written informed consent prior to trial entry

Exclusion Criteria:

- Clinically relevant digestive, renal or metabolic disease, as determined by the
medical (screening) visit and a standard blood chemistry analysis (glucose, total
cholesterol, LDL, HDL, triglycerides, Aspartate aminotransferase (ASAT), Alanine
aminotransferase (ALAT), gamma glutamyl transferase (Gamma-GT), C reactive protein
(CRP), creatinine)

- Undergoing regular medical treatment, pain-killers accepted, based on the medical
questionnaire

- Special diets: vegetarian, high protein or weight loss program (anamnesis)

- Pregnancy (anamnesis)

- Food allergy

- Participation in a cholesterol management program with functional foods like food
supplement enriched in omega-3 fatty acids, dairy products enriched with phytosterols
(margarines, yoghurts), evaluated during the medical visit

- Practicing more than 5 moderated physical activity per week

- Smoker (anamnesis)

- Have a high alcohol consumption (more than 2 drinks/day) (anamnesis)

- Consumption of illicit drugs, (anamnesis)

- Having given blood within the last month, or willing to make a blood donation until
one month following the end of the study

- Subject who cannot be expected to comply with the study procedures, including
consuming the test products.

- Currently participating or having participated in another clinical trial during the
last month prior to the beginning of this study.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Other: Animal-based protein diet

Other: Vegan-based protein diet

Primary Outcome(s)

Intra-individual plasma biochemistry response to acute controlled feeding [Time Frame: Day 1 and 3 of diet challenge 1, 1-Day baseline after challenge 1 washout, Day 1 and 3 of diet challenge 2, 1-Day baseline after challenge 2 washout]

Intra-individual plasma, stools, and urine omics to acute controlled feeding [Time Frame: 3-Day baseline, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout]

Secondary Outcome(s)

Subject's omics adaptation phase to a controlled diet Subject's omics adaptation phase to a controlled diet [Time Frame: 3-Day diet challenge 1 and 2]

Pairing of gut microbial metabolite to gut microbial composition to generate concept on gut functional system to be followed-up in future studies [Time Frame: 3-Day baseline before start of diet challenges, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout]

Comparison of intra-individual daytime plasma response amongst diets and free living restricted diets [Time Frame: 3-Day baseline before start of diet challenges, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout]

Pairing dietary intake and preferences with subjects response in Omics endpoints [Time Frame: 3-Day baseline before start of diet challenges, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout]

Secondary ID(s)

13.28.MET

Source(s) of Monetary Support

Please refer to primary and secondary sponsors