HealthyNCT02223585
Gut Microbiota and Proteins Intake
A study testing Animal-based protein diet and Vegan-based protein diet in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Gut microbiota are involved in the regulation of mammalian metabolic pathways through host-microbiota metabolic, signaling, and immune-inflammatory interactions that physiologically connect the gut, liver, brain, and other organs. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Animal-based protein diet and Vegan-based protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Metabolic Unit, Clinical Development Unit, Nestec
Lausanne, 1000
About this study
Official title: Gut Microbial Response to Well-balanced Diet With Emphasis on Animal or Vegan Protein
Gut microbiota are involved in the regulation of mammalian metabolic pathways through host-microbiota metabolic, signaling, and immune-inflammatory interactions that physiologically connect the gut, liver, brain, and other organs. Correlation of these metabotypes with gut microbial profiles facilitates deciphering inherent host-microbe relationships.
Microbiome sequencing have generated novel insights into the role of gut microbial composition in health and disease, but are limited in addressing the microbial contribution to host metabolism and the gut microbial dysbiosis in disease.
This is an exploratory trial, aiming to examine how gut microbial conditions determine response to dietary challenge by measuring urine, plasma and stool metabolites resulting from metabolism of protein, polyamines and bile acids in combination with stool bacterial composition. The focus of this trial is to evaluate impact of protein based food challenges, based on cross-over design of two diet challenges of animal and vegan protein sources.
- Conditions
- Healthy
- Being tested
- Animal-based protein diet, Vegan-based protein diet
- Keywords
- Gut microbial, response, to protein-based, diet, challenges, population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-based protein dietOther
Vegan-based protein dietOther
| Study group | Role | What they receive |
|---|---|---|
| Cross-over single arm | Experimental | Not described Receives: Other: Animal-based protein diet; Other: Vegan-based protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-individual plasma, stools, and urine omics to acute controlled feeding
Metabonomics on fasting blood, urine, and stools and microbiota composition by 1. defining individual baseline (3-Day baseline before start of diet challenges); 2. Examining effect of the dietary challenges (3-Day diet challenge vs. Baseline); 3. Examining global dietary effect (baseline after challenge 2 vs. baseline after challenge 1) and stability of dietary effect (3rd day of each diet challenge vs. baseline after the challenge)
Measured: 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
Intra-individual plasma biochemistry response to acute controlled feeding
To evaluate effect of the dietary challenges (Day 3 vs Day1 of each diet challenge), the global dietary effect (baseline after challenge 2 vs. the baseline after challenge 1, Day 1 of diet challenge 1), stability of the dietary effect (3rd day of each diet challenge vs. baseline after the challenge)
Measured: 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
Secondary outcomes (4)
Subject's omics adaptation phase to a controlled diet Subject's omics adaptation phase to a controlled diet
Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition
Measured: 3-Day diet challenge 1 and 2
Comparison of intra-individual daytime plasma response amongst diets and free living restricted diets
Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition
Measured: 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 of gut microbial metabolite to gut microbial composition to generate concept on gut functional system to be followed-up in future studies
Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition
Measured: 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
Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition and 3- Days dietary recall during diet challenges and food frequency questionnaire at baseline before start of diet challenges
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurice Beaumont, MD, PhD, PD Dr, Principal investigator, Metabolic Unit, Clinical Development Unit, Nestec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223585
- Sponsor's protocol ID
- 13.28.MET
- Status last verified
- Apr 2015
- First submitted
- 21 Aug 2014
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Draper CF, Tini G, Vassallo I, Godin JP, Su M, Jia W, Beaumont M, Moco S, Martin FP. Vegan and Animal Meal Composition and Timing Influence Glucose and Lipid Related Postprandial Metabolic Profiles. Mol Nutr Food Res. 2019 Mar;63(5):e1800568. doi: 10.1002/mnfr.201800568. Epub 2019 Feb 21.
PubMed 30724465
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbial Response to Well-balanced Diet With Emphasis on Animal or Vegan Protein
- ClinicalTrials.gov ID
- NCT02223585
- Acronym / sponsor ID
- 13.28.MET
- Conditions
- Healthy
- Keywords
- Gut microbial, response, to protein-based, diet, challenges, population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gut microbiota are involved in the regulation of mammalian metabolic pathways through host-microbiota metabolic, signaling, and immune-inflammatory interactions that physiologically connect the gut, liver, brain, and other organs. Correlation of these metabotypes with gut microbial profiles facilitates deciphering inherent host-microbe relationships.
Microbiome sequencing have generated novel insights into the role of gut microbial composition in health and disease, but are limited in addressing the microbial contribution to host metabolism and the gut microbial dysbiosis in disease.
This is an exploratory trial, aiming to examine how gut microbial conditions determine response to dietary challenge by measuring urine, plasma and stool metabolites resulting from metabolism of protein, polyamines and bile acids in combination with stool bacterial composition. The focus of this trial is to evaluate impact of protein based food challenges, based on cross-over design of two diet challenges of animal and vegan protein sources.
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross-over single arm | Experimental | Other: Animal-based protein diet, Other: Vegan-based protein diet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-based protein diet | Other | Cross-over single arm |
| Vegan-based protein diet | Other | Cross-over single arm |
Primary outcome
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
Metabonomics on fasting blood, urine, and stools and microbiota composition by 1. defining individual baseline (3-Day baseline before start of diet challenges); 2. Examining effect of the dietary challenges (3-Day diet challenge vs. Baseline); 3. Examining global dietary effect (baseline after challenge 2 vs. baseline after challenge 1) and stability of dietary effect (3rd day of each diet challenge vs. baseline after the challenge)
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
To evaluate effect of the dietary challenges (Day 3 vs Day1 of each diet challenge), the global dietary effect (baseline after challenge 2 vs. the baseline after challenge 1, Day 1 of diet challenge 1), stability of the dietary effect (3rd day of each diet challenge vs. baseline after the challenge)
4 secondary outcomes
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
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 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
- Derived from this study: PubMed 30724465Draper CF, Tini G, Vassallo I, Godin JP, Su M, Jia W, Beaumont M, Moco S, Martin FP. Vegan and Animal Meal Composition and Timing Influence Glucose and Lipid Related Postprandial Metabolic Profiles. Mol Nutr Food Res. 2019 Mar;63(5):e1800568. doi: 10.1002/mnfr.201800568. Epub 2019 Feb 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Beaumont, MD, PhD, PD Dr principal investigator
Metabolic Unit, Clinical Development Unit, Nestec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-based protein diet and Vegan-based protein diet in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02223585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2015.