Healthy Men and WomenNCT05058157
Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
A study testing different ketogenic formulae in people with Healthy Men and Women, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
This research project aims at evaluating the effect of various ketone precursors and their formulations on blood ketone level after oral intake. Evaluation of the GI tolerability of the various formula will be also evaluated. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Men and Women
- What is being tested?
- different ketogenic formulae
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Aug 2023to Dec 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women, based on the screening visit and medical history,
- BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27;
- Able to understand and sign informed consent form.
Who cannot join
- Any medication possibly impacting the postprandial glucose and insulin response (based on anamnesis),
- Any medication impacting dietary fat absorption and metabolism,
- Pregnancy (on anamnesis) and/or lactation,
- Known food allergy and food intolerance,
- Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional,
- Individuals under ketogenic diets, or taking regular ketones products,
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- Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of bier,
- Having given blood within the last month, or willing to make a blood donation until one month following the end of the study,
- Family or hierarchical relationships with Clinical Innovation Lab at Nestlé Research, Lausanne, Switzerland,
- Volunteer who cannot be expected to comply with the protocol,
- Smokers unable to stop for the day of the visit.
Trial locations and contacts
1 site in 1 country.
About this study
This research project aims at evaluating the effect of various ketone precursors and their formulations on blood ketone level after oral intake. Evaluation of the GI tolerability of the various formula will be also evaluated.
- Conditions
- Healthy Men and Women
- Being tested
- different ketogenic formulae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different ketogenic formulaeDietary supplement
The research product may be in a form of powder to reconstitute or in a ready-to-drink format.
| Study group | Role | What they receive |
|---|---|---|
| Ketone Precursor Formula 1 | Active comparator | Formula 1 (in each cycle, up to 4 formula will be tested) Ketone precursors formula (powder to reconstitute in drinking water, or in a ready-to-drink format). Receives: Dietary Supplement: different ketogenic formulae |
| Ketone Precursor Formula 2 | Active comparator | Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format). Receives: Dietary Supplement: different ketogenic formulae |
| Ketone Precursor Formula 3 | Active comparator | Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format) Receives: Dietary Supplement: different ketogenic formulae |
| Ketone Precursor Formula 4 | Active comparator | Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format), or placebo Receives: Dietary Supplement: different ketogenic formulae |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
Incremental area under the curve of total blood ketones
Measured: 0 (baseline) to 4 hours after products consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start21 Aug 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Men and WomenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each testing cycle design will be either a complete or partial cross-over.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Sun, Principal investigator, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058157
- Sponsor's protocol ID
- 1803NR
- Status last verified
- Oct 2023
- First submitted
- 16 Sep 2021
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
- ClinicalTrials.gov ID
- NCT05058157
- Acronym / sponsor ID
- 1803NR
- Conditions
- Healthy Men and Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Sep 2021 (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.
This research project aims at evaluating the effect of various ketone precursors and their formulations on blood ketone level after oral intake. Evaluation of the GI tolerability of the various formula will be also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Each testing cycle design will be either a complete or partial cross-over.
| Arm | Type | Receives |
|---|---|---|
| Ketone Precursor Formula 1 | Active comparator | Dietary Supplement: different ketogenic formulaeFormula 1 (in each cycle, up to 4 formula will be tested) Ketone precursors formula (powder to reconstitute in drinking water, or in a ready-to-drink format). |
| Ketone Precursor Formula 2 | Active comparator | Dietary Supplement: different ketogenic formulaeKetone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format). |
| Ketone Precursor Formula 3 | Active comparator | Dietary Supplement: different ketogenic formulaeKetone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format) |
| Ketone Precursor Formula 4 | Active comparator | Dietary Supplement: different ketogenic formulaeKetone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format), or placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women, based on the screening visit and medical history,
- BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27;
- Able to understand and sign informed consent form.
Key exclusion criteria (11 listed)
- Any medication possibly impacting the postprandial glucose and insulin response (based on anamnesis),
- Any medication impacting dietary fat absorption and metabolism,
- Pregnancy (on anamnesis) and/or lactation,
- Known food allergy and food intolerance,
- Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional,
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 |
|---|---|---|
| different ketogenic formulaeThe research product may be in a form of powder to reconstitute or in a ready-to-drink format. | Dietary supplement | Ketone Precursor Formula 1, Ketone Precursor Formula 2, Ketone Precursor Formula 3, Ketone Precursor Formula 4 |
Primary outcome
Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
Time frame: 0 (baseline) to 4 hours after products consumption
Incremental area under the curve of total blood ketones
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Pamela Sun principal investigator
Société des Produits Nestlé (SPN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different ketogenic formulae in people with Healthy Men and Women, 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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?
Results are not available in the source record.
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?
Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae (time frame: 0 (baseline) to 4 hours after products consumption). 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 17 Oct 2023.