Type 2 DiabetesNCT04905589
Medium Chain Triglycerides (MCT) and Whey Protein Isolate (WPI) for Type 2 Diabetes Patients (Combine)
A study testing BetaQuik™, WheyBasics and Iso-voluminous water in people with Type 2 Diabetes, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
Trial summary
Evaluation of effect on diurnal glycaemia following consumption of MCT and whey protein in patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- BetaQuik™, WheyBasics and Iso-voluminous water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2021to 1 Aug 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 25 to 65 years of age, inclusive.
- Subjects with a BMI of ≤ 40kg/m2.
- Established diagnosis of Type 2 diabetes mellitus (T2DM), documented by either HbA1c 6.5 -10.0% or active therapy with metformin at a daily dose of up to 3000 mg at screening.
- Willing and able to sign written informed consent prior to study entry.
- Subjects with laboratory parameters within normal range, or showing no clinically relevant deviations, as judged by the investigator.
- Willing and able to comply with the requirements of the study protocol.
Who cannot join
- Fasting blood glucose >11mmol/L at screening.
- Elevated liver transaminases > 3 Upper limit of normal at screening.
- Ongoing or recent (i.e. < 3month) insulin therapy.
- Ongoing or recent (i.e. < 3month) GLP-1 therapy.
- Ongoing or recent (i.e. < 3month) treatment with any oral or injectable glucose-lowering drug other than metformin.
- Ongoing or recent weight loss interventions (e.g. dietary weight loss programmes) or any history of bariatric surgery.
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- Ongoing treatment with anorectic drugs, steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
- Major medical/surgical event requiring hospitalization in the last 3 months.
- Known allergy and intolerance to product components.
- Alcohol intake higher than 4 units per day in line with National Health Service guidelines.
- History of regular smoking (daily or most days in a week) or use of nicotine products (3 or more nicotine containing products).
- Have a hierarchical link with the research team members.
- Subjects who have been dosed in another clinical trial with any investigational drug/new chemical entity within 3 months or 5 half-lives (whichever is longer) prior to screening, or subjects currently participating in any investigational trial.
- Positive pregnancy test at screening for women of child-bearing potential.
- Subject who, in the judgment of the investigator, is likely to be noncompliant or uncooperative during the study due to language barrier, poor mental development or any other reason.
- Subjects with fasting blood glucose that is not within 20% of the value at the previous study visit. Note: In such cases, subjects can come in on another day within the visit window at the discretion of the investigator, however, subjects will be discontinued if the same observation is made at the new visit.
- Evidence of eating disorders and regularly skipping breakfast and dinner.
- Current or recent history (in last 3 months) of clinically significant gastrointestinal, liver, cardiovascular, clotting, metabolic or endocrine disorders, apart from T2DM, that in the opinion of the investigator might put the subject at risk by entering the study or interfere with the aims of the study.
- Total score of ≥ 20 on the Eating Attitude Test (EAT-26) at the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Combined Intake of Medium Chain Triglycerides (MCT) At Breakfast and Whey Protein Isolate (WPI) Preload At Lunch and Dinner on Diurnal Glucose and Satiety
Evaluation of effect on diurnal glycaemia following consumption of MCT and whey protein in patients with type 2 diabetes
Read the detailed description
The purpose of this study (Combine) is to evaluate the effects of Combined Intake of Medium chain triglycerides (MCT) at breakfast and whey protein isolate (WPI) preload at lunch and dinner for patients with type 2 diabetes
- Conditions
- Type 2 Diabetes
- Being tested
- BetaQuik™, WheyBasics, Iso-voluminous water
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetaQuik™Dietary supplement
MCT (Medium chain triglycerides)
WheyBasicsDietary supplement
Whey Protein Isolate
Iso-voluminous waterOther
Iso-voluminous Water as comparitor to Betaquik or WheyBasics
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Placebo comparator | Subsequent order of intake :
Iso-voluminous water, breakfast, iso-voluminous water, lunch, iso-voluminous water, dinner Receives: Other: Iso-voluminous water |
| ARM B | Active comparator | Subsequent order of intake :
MCT in liquid form (75 ml of BetaQuik™), breakfast, iso-voluminous water, lunch, iso-voluminous water, dinner Receives: Dietary Supplement: BetaQuik™; Other: Iso-voluminous water |
| ARM C | Active comparator | Subsequent order of intake:
MCT in liquid form (75 ml of BetaQuik™), breakfast, WPI in liquid from (12.5g of WheyBasics in 200ml water), lunch, WPI in liquid from (12.5g of WheyBasics in 200ml water)), dinner Receives: Dietary Supplement: BetaQuik™; Dietary Supplement: WheyBasics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diurnal glucose Incremental area under curve (iAUC) concentrations
Constant glucose monitoring (CGM) comparing treatment regimen A-B-C
Measured: 115 days
Secondary outcomes (14)
Glucose concentrations
Mean, standard deviation and coefficient of variation of 24h glucose concentration as 24h 24h assessed by CGM
Measured: 115 days
Area under curve (AUC) glucose
24h assessed by CGM
Measured: 115 days
Incremental area under curve (iAUC) glucose
24h assessed by CGM
Measured: 115 days
Visual Analogue Scale (VAS) questionnaire
100-point VAS on satiety
Measured: 115 days
Glucose mean
Arterialised blood concentration
Measured: 115 days
Glucose Incremental area under curve (iAUC)
Arterialised blood concentration
Measured: 115 days
Leptin mean
Arterialised blood concentration
Measured: 115 days
Leptin Incremental area under curve (iAUC)
Arterialised blood concentration
Measured: 115 days
Gastric inhibitory polypeptide (GIP) - GLP-1 mean
Arterialised blood concentration
Measured: 115 days
Glucagon-like peptide-1 (GLP-1) mean
Arterialised blood concentration
Measured: 115 days
Gastric inhibitory polypeptide (GIP) - Incremental area under curve (iAUC)
Arterialised blood concentration
Measured: 115 days
Glucagon-like peptide-1 (GLP-1) Incremental area under curve (iAUC)
Arterialised blood concentration
Measured: 115 days
Peptide tyrosine tyrosine (PYY) mean
Arterialised blood concentration
Measured: 115 days
Peptide tyrosine tyrosine (PYY) Incremental area under curve (iAUC)
Arterialised blood concentration
Measured: 115 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start30 Apr 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
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 Type 2 DiabetesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open-label - randomization-concealed trial randomized in a 1:1:1 ratio
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor Kostas Tsintzas, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905589
- Sponsor's protocol ID
- 19.18.CLI
- Status last verified
- Oct 2024
- First submitted
- 12 May 2021
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pabla P, Mallinson J, Nixon A, Keeton M, Cooper S, Marshall M, Jacques M, Brown S, Johansen OE, Cuenoud B, Karagounis LG, Tsintzas K. Effect of medium-chain triglycerides and whey protein isolate preloads on glycaemia in type 2 diabetes: a randomized crossover study. Am J Clin Nutr. 2025 Feb;121(2):232-245. doi: 10.1016/j.ajcnut.2024.12.022. Epub 2024 Dec 26.
PubMed 39732398
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Intake of Medium Chain Triglycerides (MCT) At Breakfast and Whey Protein Isolate (WPI) Preload At Lunch and Dinner on Diurnal Glucose and Satiety
- ClinicalTrials.gov ID
- NCT04905589
- Acronym / sponsor ID
- 19.18.CLI
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 27 May 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.
Evaluation of effect on diurnal glycaemia following consumption of MCT and whey protein in patients with type 2 diabetes
Detailed description
The purpose of this study (Combine) is to evaluate the effects of Combined Intake of Medium chain triglycerides (MCT) at breakfast and whey protein isolate (WPI) preload at lunch and dinner for patients with type 2 diabetes
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-label - randomization-concealed trial randomized in a 1:1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| ARM A | Placebo comparator | Other: Iso-voluminous waterSubsequent order of intake : Iso-voluminous water, breakfast, iso-voluminous water, lunch, iso-voluminous water, dinner |
| ARM B | Active comparator | Dietary Supplement: BetaQuik™, Other: Iso-voluminous waterSubsequent order of intake : MCT in liquid form (75 ml of BetaQuik™), breakfast, iso-voluminous water, lunch, iso-voluminous water, dinner |
| ARM C | Active comparator | Dietary Supplement: BetaQuik™, Dietary Supplement: WheyBasicsSubsequent order of intake: MCT in liquid form (75 ml of BetaQuik™), breakfast, WPI in liquid from (12.5g of WheyBasics in 200ml water), lunch, WPI in liquid from (12.5g of WheyBasics in 200ml water)), dinner |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects, 25 to 65 years of age, inclusive.
- Subjects with a BMI of ≤ 40kg/m2.
- Established diagnosis of Type 2 diabetes mellitus (T2DM), documented by either HbA1c 6.5 -10.0% or active therapy with metformin at a daily dose of up to 3000 mg at screening.
- Willing and able to sign written informed consent prior to study entry.
- Subjects with laboratory parameters within normal range, or showing no clinically relevant deviations, as judged by the investigator.
Key exclusion criteria (19 listed)
- Fasting blood glucose >11mmol/L at screening.
- Elevated liver transaminases > 3 Upper limit of normal at screening.
- Ongoing or recent (i.e. < 3month) insulin therapy.
- Ongoing or recent (i.e. < 3month) GLP-1 therapy.
- Ongoing or recent (i.e. < 3month) treatment with any oral or injectable glucose-lowering drug other than metformin.
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 |
|---|---|---|
| BetaQuik™MCT (Medium chain triglycerides) | Dietary supplement | ARM B, ARM C |
| WheyBasicsWhey Protein Isolate | Dietary supplement | ARM C |
| Iso-voluminous waterIso-voluminous Water as comparitor to Betaquik or WheyBasics | Other | ARM A, ARM B |
Primary outcome
Diurnal glucose Incremental area under curve (iAUC) concentrations
Time frame: 115 days
Constant glucose monitoring (CGM) comparing treatment regimen A-B-C
14 secondary outcomes
Glucose concentrations
Time frame: 115 days
Area under curve (AUC) glucose
Time frame: 115 days
Incremental area under curve (iAUC) glucose
Time frame: 115 days
Visual Analogue Scale (VAS) questionnaire
Time frame: 115 days
Glucose mean
Time frame: 115 days
Glucose Incremental area under curve (iAUC)
Time frame: 115 days
Leptin mean
Time frame: 115 days
Leptin Incremental area under curve (iAUC)
Time frame: 115 days
Gastric inhibitory polypeptide (GIP) - GLP-1 mean
Time frame: 115 days
Glucagon-like peptide-1 (GLP-1) mean
Time frame: 115 days
Gastric inhibitory polypeptide (GIP) - Incremental area under curve (iAUC)
Time frame: 115 days
Glucagon-like peptide-1 (GLP-1) Incremental area under curve (iAUC)
Time frame: 115 days
Peptide tyrosine tyrosine (PYY) mean
Time frame: 115 days
Peptide tyrosine tyrosine (PYY) Incremental area under curve (iAUC)
Time frame: 115 days
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 22 Oct 2024.
- Derived from this study: PubMed 39732398Pabla P, Mallinson J, Nixon A, Keeton M, Cooper S, Marshall M, Jacques M, Brown S, Johansen OE, Cuenoud B, Karagounis LG, Tsintzas K. Effect of medium-chain triglycerides and whey protein isolate preloads on glycaemia in type 2 diabetes: a randomized crossover study. Am J Clin Nutr. 2025 Feb;121(2):232-245. doi: 10.1016/j.ajcnut.2024.12.022. Epub 2024 Dec 26.
- Individual participant dataSharing planned: No
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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.
Professor Kostas Tsintzas principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BetaQuik™, WheyBasics and Iso-voluminous water in people with Type 2 Diabetes, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
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 6 inclusion and 19 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 22 Oct 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 United Kingdom. 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?
Diurnal glucose Incremental area under curve (iAUC) concentrations (time frame: 115 days). 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 NCT04905589, 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 22 Oct 2024.