HealthyNCT03603782
Ketone Plasma Kinetics After Oral Intake Of Different MCT
A study testing 2.5% protein, protein 5% and protein 10% in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
This research project is aimed at identifying the MCT formulation matrixes that provide the highest ketoindex values and extended half-life, as well as to provide an initial evaluation of the GI tolerability of the various formula. For comparison, ketones salts and esters (food grade) 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
- What is being tested?
- 2.5% protein, protein 5% and protein 10%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Jun 2018to 31 May 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
- Age: 18-50 years
- Healthy men and women, based on the medical screening visit and medical history
- BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27.
- Able to understand and to sign a written informed consent prior to study entry
Who cannot join
- Any medication possibly impacting the postprandial glucose and insulin response (on anamnesis, to the opinion of the medical expert)
- Any medication impacting dietary fat absorption and metabolism or impacting postprandial glucose and insulin response, to the opinion of the medical expert
- 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 such as MCT, ketone esters or ketone salts (calcium, magnesium, sodium, potassium)
Show all 11Show fewer
- 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
- Participant having a hierarchical link with the research team members
- Not expected to follow the protocol.
- Smokers unable to stop for the day of the visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketone Plasma Kinetics After Oral Intake Of Different MCT Formulae
This research project is aimed at identifying the MCT formulation matrixes that provide the highest ketoindex values and extended half-life, as well as to provide an initial evaluation of the GI tolerability of the various formula. For comparison, ketones salts and esters (food grade) will be also evaluated.
Read the detailed description
Monocentric, open, randomized, controlled research project. The global research project will include several testing cycles as described in the figure 1. In each cycle, several research products (up to 4) will be tested on up to 20 participants in a partial or full cross-over design. Once cycle 1 is completed, blood parameters will be analysed and ketoindex will be calculated as area under the curve (AUC) of total ketones (BHB + AcA) over 4h / quantity of ingested MCTs in g. Based on ketoindex and ketones Thalf (T1/2: time to reach half of AUC-infinite of total ketones) values, new products will be developed for cycle 2.
- Conditions
- Healthy
- Being tested
- 2.5% protein, protein 5%, protein 10%, protein 15%, A2: Peptamen 1.5 Vanilla without Breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5% proteinDietary supplement
2.5%
protein 5%Dietary supplement
5%
protein 10%Dietary supplement
10%
protein 15%Dietary supplement
15%
A2: Peptamen 1.5 Vanilla without BreakfastDietary supplement
Peptamen withoug breakfast
B2: only breakfast (no product)Dietary supplement
only breakfast
C2: 5% protein with breakfastDietary supplement
C2: 5% protein consumed with breakfast
D2: 5% protein 30 min before breakfastDietary supplement
D2: 5% protein consumed 30 min before breakfast
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: protein 5%; Dietary Supplement: protein 10%; Dietary Supplement: protein 15%; Dietary Supplement: B2: only breakfast (no product); Dietary Supplement: C2: 5% protein with breakfast; Dietary Supplement: D2: 5% protein 30 min before breakfast |
| 2 | Experimental | Not described Receives: Dietary Supplement: 2.5% protein; Dietary Supplement: protein 10%; Dietary Supplement: protein 15%; Dietary Supplement: A2: Peptamen 1.5 Vanilla without Breakfast; Dietary Supplement: C2: 5% protein with breakfast; Dietary Supplement: D2: 5% protein 30 min before breakfast |
| 3 | Experimental | Not described Receives: Dietary Supplement: 2.5% protein; Dietary Supplement: protein 5%; Dietary Supplement: protein 15%; Dietary Supplement: A2: Peptamen 1.5 Vanilla without Breakfast; Dietary Supplement: B2: only breakfast (no product); Dietary Supplement: D2: 5% protein 30 min before breakfast |
| 4 | Experimental | Not described Receives: Dietary Supplement: 2.5% protein; Dietary Supplement: protein 5%; Dietary Supplement: protein 10%; Dietary Supplement: A2: Peptamen 1.5 Vanilla without Breakfast; Dietary Supplement: B2: only breakfast (no product); Dietary Supplement: C2: 5% protein with breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
KetoIndex - plasma concentration
KetoIndex calculated as area under the plasma concentration versus time curve (AUC) of total ketones (BHB + AcA) over 4 hours after MCT-based products consumption / quantity of ingested MCTs in gram.
Measured: 4 hours
total ketones (BHB+ACA) - Half-life time
Half-Life time (T ½) calculated as time to reach half of Area under the plasma concentration versus time curve (AUC)-infinite of total ketones (BHB+ACA) after MCT-based products consumption.
Measured: 4 hours
Secondary outcomes (14)
Ketones blood kinetic - Plasma concentration
(Total Ketones, BHB, AcA) measured as plasma concentration versus time curve (AUCs) after MCT-based products consumption
Measured: 4 hours
Ketones blood kinetics - peak plasma concentration
Peak Plasma Concentration (Cmax) of total Ketones, BHB, AcA MCT-based products consumption.
Measured: 4 hours
Ketones blood kinetics - time to maximum concentration
Time to maximum concentration (Tmax) of total Ketones, BHB, AcA MCT-based products consumption.
Measured: 4 hours
Ketones blood kinetics - Half-life time
Half-Life time (T ½) measured of total Ketones, BHB, AcA after MCT-based products consumption.
Measured: 4 hours
Medium chain fatty acid C8 and C10 - plasma concentration
Measure of plasma concentration versus time curve (AUCs) of Medium chain fatty acid C8 and C10 after MCT-based products consumption
Measured: 4 hours
Medium chain fatty acid C8 and C10 - concentration
Maximum plasma Concentration (Cmax) of Medium chain fatty acid C8 and C10 (and their metabolites) after MCT-based products consumption
Measured: 4 hours
Medium chain fatty acid C8 and C10 - Time to maximum concentration
Time to maximum concentration (Tmax) of Medium chain fatty acid C8 and C10 (and their metabolites) after MCT-based products consumption
Measured: 4 hours
Medium chain fatty acid C8 and C10 - Half-life time
Half-Life time (T ½) measured of Medium chain fatty acid C8 and C10 (and their metabolites) after MCT-based products consumption
Measured: 4 hours
Glucose and insulin - plasma concentration
Measure of plasma concentration versus time curve (AUCs) of glucose and insuline after MCT-based products consumption
Measured: 4 hours
Glucose and insulin - peak plasma concentration
Measure of maximum plasma concentration (Cmax) of glucose and insuline after MCT-based products consumption
Measured: 4 hours
Glucose and insulin - time to maximum concentration
Measure of time to maximum concentration (Tmax) of glucose and insuline after MCT-based products consumption
Measured: 4 hours
Glucose and insulin- Half-life time
Measure of Half-life time (T½) of of glucose and insuline after MCT-based products consumption
Measured: 4 hours
Gastro-intestinal tolerability assessment
Gastro-intestinal tolerability assessment with visual analogue scales for each symptom of interest (i.e.) 1) Abdominal discomfort , 2) Decreased appetite, 3) Gastric reflux, 4) Nausea, 5) Diarrhea, 6) Headache). Each scale are from 0 (better outcome) to 100 (worst outcome).
Measured: 24 hours
Adverse event incidence
Adverse events incidence
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start4 Jun 2018
- Primary completion31 May 2024
- Study completion31 May 2024
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Maurice Beaumont, dr, Study director, Nestec Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603782
- Sponsor's protocol ID
- 18.03.NRC
- Status last verified
- Sep 2024
- First submitted
- 14 Jun 2018
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketone Plasma Kinetics After Oral Intake Of Different MCT Formulae
- ClinicalTrials.gov ID
- NCT03603782
- Acronym / sponsor ID
- 18.03.NRC
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 27 Jul 2018 (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 is aimed at identifying the MCT formulation matrixes that provide the highest ketoindex values and extended half-life, as well as to provide an initial evaluation of the GI tolerability of the various formula. For comparison, ketones salts and esters (food grade) will be also evaluated.
Detailed description
Monocentric, open, randomized, controlled research project. The global research project will include several testing cycles as described in the figure 1. In each cycle, several research products (up to 4) will be tested on up to 20 participants in a partial or full cross-over design. Once cycle 1 is completed, blood parameters will be analysed and ketoindex will be calculated as area under the curve (AUC) of total ketones (BHB + AcA) over 4h / quantity of ingested MCTs in g. Based on ketoindex and ketones Thalf (T1/2: time to reach half of AUC-infinite of total ketones) values, new products will be developed for cycle 2.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: protein 5%, Dietary Supplement: protein 10%, Dietary Supplement: protein 15%, Dietary Supplement: B2: only breakfast (no product), Dietary Supplement: C2: 5% protein with breakfast, Dietary Supplement: D2: 5% protein 30 min before breakfast |
| 2 | Experimental | Dietary Supplement: 2.5% protein, Dietary Supplement: protein 10%, Dietary Supplement: protein 15%, Dietary Supplement: A2: Peptamen 1.5 Vanilla without Breakfast, Dietary Supplement: C2: 5% protein with breakfast, Dietary Supplement: D2: 5% protein 30 min before breakfast |
| 3 | Experimental | Dietary Supplement: 2.5% protein, Dietary Supplement: protein 5%, Dietary Supplement: protein 15%, Dietary Supplement: A2: Peptamen 1.5 Vanilla without Breakfast, Dietary Supplement: B2: only breakfast (no product), Dietary Supplement: D2: 5% protein 30 min before breakfast |
| 4 | Experimental | Dietary Supplement: 2.5% protein, Dietary Supplement: protein 5%, Dietary Supplement: protein 10%, Dietary Supplement: A2: Peptamen 1.5 Vanilla without Breakfast, Dietary Supplement: B2: only breakfast (no product), Dietary Supplement: C2: 5% protein with breakfast |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-50 years
- Healthy men and women, based on the medical screening visit and medical history
- BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27.
- Able to understand and to sign a written informed consent prior to study entry
Key exclusion criteria (11 listed)
- Any medication possibly impacting the postprandial glucose and insulin response (on anamnesis, to the opinion of the medical expert)
- Any medication impacting dietary fat absorption and metabolism or impacting postprandial glucose and insulin response, to the opinion of the medical expert
- 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 |
|---|---|---|
| 2.5% protein2.5% | Dietary supplement | 2, 3, 4 |
| protein 5%5% | Dietary supplement | 1, 3, 4 |
| protein 10%10% | Dietary supplement | 1, 2, 4 |
| protein 15%15% | Dietary supplement | 1, 2, 3 |
| A2: Peptamen 1.5 Vanilla without BreakfastPeptamen withoug breakfast | Dietary supplement | 2, 3, 4 |
| B2: only breakfast (no product)only breakfast | Dietary supplement | 1, 3, 4 |
| C2: 5% protein with breakfastC2: 5% protein consumed with breakfast | Dietary supplement | 1, 2, 4 |
| D2: 5% protein 30 min before breakfastD2: 5% protein consumed 30 min before breakfast | Dietary supplement | 1, 2, 3 |
Primary outcome
KetoIndex - plasma concentration
Time frame: 4 hours
KetoIndex calculated as area under the plasma concentration versus time curve (AUC) of total ketones (BHB + AcA) over 4 hours after MCT-based products consumption / quantity of ingested MCTs in gram.
total ketones (BHB+ACA) - Half-life time
Time frame: 4 hours
Half-Life time (T ½) calculated as time to reach half of Area under the plasma concentration versus time curve (AUC)-infinite of total ketones (BHB+ACA) after MCT-based products consumption.
14 secondary outcomes
Ketones blood kinetic - Plasma concentration
Time frame: 4 hours
Ketones blood kinetics - peak plasma concentration
Time frame: 4 hours
Ketones blood kinetics - time to maximum concentration
Time frame: 4 hours
Ketones blood kinetics - Half-life time
Time frame: 4 hours
Medium chain fatty acid C8 and C10 - plasma concentration
Time frame: 4 hours
Medium chain fatty acid C8 and C10 - concentration
Time frame: 4 hours
Medium chain fatty acid C8 and C10 - Time to maximum concentration
Time frame: 4 hours
Medium chain fatty acid C8 and C10 - Half-life time
Time frame: 4 hours
Glucose and insulin - plasma concentration
Time frame: 4 hours
Glucose and insulin - peak plasma concentration
Time frame: 4 hours
Glucose and insulin - time to maximum concentration
Time frame: 4 hours
Glucose and insulin- Half-life time
Time frame: 4 hours
Gastro-intestinal tolerability assessment
Time frame: 24 hours
Adverse event incidence
Time frame: 24 hours
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 19 Sep 2024.
- 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.
Maurice Beaumont, dr study director
Nestec Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2.5% protein, protein 5% and protein 10% 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 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
KetoIndex - plasma concentration (time frame: 4 hours). 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?
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 19 Sep 2024.