HealthyNCT05459662
Impact of Consuming a Plant-based Enriched Meal on the Adult Gut Microbiome
A study testing oat based porridge and plant based preparation in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The aim of this study is to evaluate the impact of a diversified plant-based meal on the gut microbiome and its composition. 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?
- oat based porridge and plant based preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 May 2022to 15 Nov 2022
- 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
- Age 18-55 years,
- Healthy participants, both male and female,
- BMI in the normal and overweight range 18.5 ≤ BMI ≤ 29.9 kg/m2,
- Able to understand and to sign a written informed consent prior to study enrolment.
Who cannot join
- Known chronic diseases or conditions for which the investigators/investigation team deem as not suitable for study participation,
- Known food allergy and intolerance e.g. lactose intolerance, nuts allergy,
- Habitually, have < 5 spontaneous bowel movements on average per week,
- Chronic or recurrent diarrhoea with spontaneous bowel movements > 2 per day
- Prior gastrointestinal surgery (apart from appendectomy or herniotomy),
- Received systemic antiviral/antibacterial/antifungal therapy during the 3 months prior to study enrolment,
Show all 16Show fewer
- Medications or supplements that are known to alter gut function or microflora i.e. acid antisecretory drugs, pre-/probiotics, laxative during the 4 weeks prior to study enrolment,
- Anti-hyperlipidaemic, antihypertensive medications and/or anticoagulant agents,
- Currently participating in another interventional clinical trial or research project,
- Alcohol intake > 2 servings per day; specifically, a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. Or other chronic substance abuse,
- Changing diet patterns due to travelling and staying abroad for more than two weeks (Asia, Africa, or Latin America) during the two months prior to study enrolment,
- Food restrictions such as vegan, vegetarian, ketogenic, low carb, paleo, raw diets, caloric restrictive diets,
- Artificially sweetened beverage intake >1000 ml/ per day,
- Female participants will be excluded if they are pregnant, have given birth in the last 6 months, or are lactating,
- Subject having a hierarchical or family link with the research team members,
- Occurrence of fever episodes, infection, or vaccination during 14 days before the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Cross-over Double Arm Control Trial Evaluating the Impact of the Daily Consumption of Plant-based Diversified Meal Over a 2 Weeks Period on the Adult Gut Microbiome
The aim of this study is to evaluate the impact of a diversified plant-based meal on the gut microbiome and its composition.
- Conditions
- Healthy
- Being tested
- oat based porridge, plant based preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oat based porridgeDietary supplement
Consume one preparation per day, orally
plant based preparationDietary supplement
Consume one preparation per day, orally
| Study group | Role | What they receive |
|---|---|---|
| Oat based porridge | Placebo comparator | Oat based porridge prepared with 64g of oat, 200ml of milk and 10 g of honey by the participant and consumed orally daily for 14 days as breakfast replacement Receives: Dietary Supplement: oat based porridge |
| Enriched plant-based meal | Active comparator | Enriched plant-based meal pots (400 g) mixed with 25g of seeds and nuts consumed orally daily for 14 days as breakfast replacement Receives: Dietary Supplement: plant based preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota diversity & composition
Measured by Next Generation Sequencing (NGS)
Measured: Throughout 14 days of product intake
Secondary outcomes (3)
Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey)
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. Score ranging from 0 to 100 (higher scores indicate better health status).
Measured: Throughout 14 days of product intake
Change in Short Chain Fatty Acids (SCFA) in the stool
Measured using Gas Chromatography (GC)
Measured: Throughout 14 days of product intake
Gastrointestinal Symptom Rating Scale (GSRS)
Validated questionnaire exploring the presence and severity of GI symptoms over the previous 7 days. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The effect of the interventions on the GSRS will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment.
Measured: Throughout 14 days of product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start5 May 2022
- Primary completion31 Jul 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459662
- Sponsor's protocol ID
- 2106NRC2
- Status last verified
- Nov 2022
- First submitted
- 24 May 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-over Double Arm Control Trial Evaluating the Impact of the Daily Consumption of Plant-based Diversified Meal Over a 2 Weeks Period on the Adult Gut Microbiome
- ClinicalTrials.gov ID
- NCT05459662
- Acronym / sponsor ID
- 2106NRC2
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 5 May 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 15 Jul 2022 (actual)
- 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.
The aim of this study is to evaluate the impact of a diversified plant-based meal on the gut microbiome and its composition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oat based porridge | Placebo comparator | Dietary Supplement: oat based porridgeOat based porridge prepared with 64g of oat, 200ml of milk and 10 g of honey by the participant and consumed orally daily for 14 days as breakfast replacement |
| Enriched plant-based meal | Active comparator | Dietary Supplement: plant based preparationEnriched plant-based meal pots (400 g) mixed with 25g of seeds and nuts consumed orally daily for 14 days as breakfast replacement |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-55 years,
- Healthy participants, both male and female,
- BMI in the normal and overweight range 18.5 ≤ BMI ≤ 29.9 kg/m2,
- Able to understand and to sign a written informed consent prior to study enrolment.
Key exclusion criteria (16 listed)
- Known chronic diseases or conditions for which the investigators/investigation team deem as not suitable for study participation,
- Known food allergy and intolerance e.g. lactose intolerance, nuts allergy,
- Habitually, have < 5 spontaneous bowel movements on average per week,
- Chronic or recurrent diarrhoea with spontaneous bowel movements > 2 per day
- Prior gastrointestinal surgery (apart from appendectomy or herniotomy),
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 |
|---|---|---|
| oat based porridgeConsume one preparation per day, orally | Dietary supplement | Oat based porridge |
| plant based preparationConsume one preparation per day, orally | Dietary supplement | Enriched plant-based meal |
Primary outcome
Microbiota diversity & composition
Time frame: Throughout 14 days of product intake
Measured by Next Generation Sequencing (NGS)
3 secondary outcomes
Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey)
Time frame: Throughout 14 days of product intake
Change in Short Chain Fatty Acids (SCFA) in the stool
Time frame: Throughout 14 days of product intake
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Throughout 14 days of product intake
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 28 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oat based porridge and plant based preparation 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 4 inclusion and 16 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 28 Nov 2022. 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. Some participants in this study may receive a placebo. 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?
Microbiota diversity & composition (time frame: Throughout 14 days of product intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2022.