PrediabetesNCT06789263
Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile, Gastric Emptying and GLP-1 Release in Normoglycemic and Prediabetic Subjects
A study testing Collagen hydrolyzed peptides in people with Prediabetes and Normoglycemic, run by Rousselot BVBA at 1 site in Germany.
Trial summary
Aim of the study is to investigate the postprandial response on blood glucose, insulin, C-peptide, incretin response and gastric emptying after intake of collagen hydrolysate compared to placebo in normoglycemic and in prediabetic participants. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Normoglycemic
- What is being tested?
- Collagen hydrolyzed peptides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jan 2025to 8 Sep 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prediabetic subjects: Male and female subjects with prediabetic HbA1c values between 5.7% and 6.4% and/or fasting glucose ≥ 100 mg/dL and ≤ 125 mg/dL (in venous plasma) (twice confirmed at two independent days if HbA1c is < 5.7%) or Healthy normoglycemic subjects: fasting glucose <100 mg/dL and HbA1c is < 5.7%
- Age: 18-70 years
- Body mass index 19-35 kg/m2
- Current Non-smoker
- Signed informed consent form
- No changes in food habits or physical activity 3 months prior to screening and during the study
- If applicable, stable intake of chronic medication of at least 4 weeks
Who cannot join
- Subjects with diagnosed Type 2 Diabetes mellitus with medical treatment
- Presence of disease or drug(s) influencing digestion (incl. recent intake of antibiotics) and absorption of nutrients
- Intake of medications known to affect glucose tolerance, e.g., diabetic medication, SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics
- Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening), which in the Investigator's opinion would impact patient safety
- Severe liver or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST >3 x ULN)
- Known inflammatory or malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis)
Show all 19Show fewer
- Subjects who use an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump.
- Planned MRI during or 4 weeks after the study.
- Subjects overweighed with abdominal diameter >140 cm
- Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
- Major medical or surgical event requiring hospitalization within the previous 3 months
- Intake of food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids
- Drug-, alcohol- and medication abuses
- Pregnant or breast-feeding women
- Weight loss intervention or recent body weight change >5 kg during the last 3 months
- Blood donation within 4 weeks prior to Screeningor plan to donate blood during the study
- Anticipating any planned changes in lifestyle for the duration of the study
- Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study
- Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile, Gastric Emptying and GLP-1 Release in Normoglycemic and Prediabetic Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Design
Aim of the study is to investigate the postprandial response on blood glucose, insulin, C-peptide, incretin response and gastric emptying after intake of collagen hydrolysate compared to placebo in normoglycemic and in prediabetic participants. This will be investigated in a cross-over randomized double-blind placebo controlled study design.
In an exploratory part II, timing of intake of collagen hydrolysate in relation to the mixed meal will be investigated in a subgroup of 50% of the participants.
- Conditions
- Prediabetes, Normoglycemic
- Being tested
- Collagen hydrolyzed peptides, Placebo
- Keywords
- glucose spikes, postprandial glucose, insulin response
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen hydrolyzed peptidesDietary supplement
Dissolved in flavoured water, single dose, 10 g
PlaceboOther
Single dose
| Study group | Role | What they receive |
|---|---|---|
| Collagen hydrolysate | Active comparator | 30 min prior to the mixed meal test Receives: Dietary Supplement: Collagen hydrolyzed peptides |
| Placebo | Placebo comparator | Flavoured water Receives: Other: Placebo |
| Collagen hydrolysate II | Other | together with the mixed meal test Receives: Dietary Supplement: Collagen hydrolyzed peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose iAUC
Area under the curve (AUC) calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration: Glucose-iAUC(0-180minutes)
Measured: 0-180 minutes postprandially
Secondary outcomes (14)
Glucose Cmax
Maximum blood glucose concentration (Cmax)
Measured: 0-180 minutes postprandially
Delta Cmax
Maximum increase of blood glucose concentration
Measured: 0-180 minutes postprandially
Tmax
Time to reach maximum blood glucose concentration (Tmax)
Measured: 0-180 minutes postprandially
Fasting glucose
Fasting glucose
Measured: -30 minutes and 0 minutes prior mixed meal
Glucose
Blood glucose concentration after mixed meal
Measured: 120 minutes
Fasting insulin
Fasting insulin
Measured: -30 minutes and 0 minutes prior to mixed meal
Insulin iAUC
Area under the curve calculated as the incremental area under the insulin curve
Measured: 0-180 minutes postprandially
Fasting C-peptide
Fasting C-peptide
Measured: -30 minutes and 0 minutes prior mixed meal
C-peptide iAUC
Area under the curve calculated as the incremental area under the C-peptide curve
Measured: 0-180 minutes postprandially
GLP-1 iAUC
Incretin response (Glucagon-like Peptide-1)
Measured: 0-120 minutes postprandially
Fasting GLP-1
Fasting GLP-1
Measured: -30 minutes and 0 minutes prior mixed meal
Matsuda-Index
Determination of Insulin sensitivity
Measured: 0-120 minutes postprandially
Gastric emptying
Time for gastric emptying
Measured: 0-6 hours postprandially
Satiety assessment
Visual analog scale (VAS) Scale (0: not at all 100: extremely)
Measured: 0-240 minutes postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start29 Jan 2025
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
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 PrediabetesStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rousselot BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789263
- Sponsor's protocol ID
- BTS2127/24
- Status last verified
- Dec 2025
- First submitted
- 15 Jan 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Virgilio N, Schon C, Steiner N, Schlageter V, Wilhelm M, Silva CI, Gevaert E, Prawitt J. Specific Collagen Peptides Support Postprandial Metabolic Health by Modulating Incretin Hormones, Gastric Transit, and Glycemic Control in Participants with Normoglycemia and Prediabetes. Curr Dev Nutr. 2026 Aug 8;10(9):109512. doi: 10.1016/j.cdnut.2026.109512. eCollection 2026 Sep.
PubMed 42699069
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile, Gastric Emptying and GLP-1 Release in Normoglycemic and Prediabetic Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Design
- ClinicalTrials.gov ID
- NCT06789263
- Acronym / sponsor ID
- BTS2127/24
- Conditions
- Prediabetes, Normoglycemic
- Keywords
- glucose spikes, postprandial glucose, insulin response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rousselot BVBAIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 23 Jan 2025 (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.
Aim of the study is to investigate the postprandial response on blood glucose, insulin, C-peptide, incretin response and gastric emptying after intake of collagen hydrolysate compared to placebo in normoglycemic and in prediabetic participants. This will be investigated in a cross-over randomized double-blind placebo controlled study design.
In an exploratory part II, timing of intake of collagen hydrolysate in relation to the mixed meal will be investigated in a subgroup of 50% of the participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Collagen hydrolysate | Active comparator | Dietary Supplement: Collagen hydrolyzed peptides30 min prior to the mixed meal test |
| Placebo | Placebo comparator | Other: PlaceboFlavoured water |
| Collagen hydrolysate II | Other | Dietary Supplement: Collagen hydrolyzed peptidestogether with the mixed meal test |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Prediabetic subjects: Male and female subjects with prediabetic HbA1c values between 5.7% and 6.4% and/or fasting glucose ≥ 100 mg/dL and ≤ 125 mg/dL (in venous plasma) (twice confirmed at two independent days if HbA1c is < 5.7%) or Healthy normoglycemic subjects: fasting glucose <100 mg/dL and HbA1c is < 5.7%
- Age: 18-70 years
- Body mass index 19-35 kg/m2
- Current Non-smoker
- Signed informed consent form
Key exclusion criteria (19 listed)
- Subjects with diagnosed Type 2 Diabetes mellitus with medical treatment
- Presence of disease or drug(s) influencing digestion (incl. recent intake of antibiotics) and absorption of nutrients
- Intake of medications known to affect glucose tolerance, e.g., diabetic medication, SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics
- Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening), which in the Investigator's opinion would impact patient safety
- Severe liver or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST >3 x ULN)
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 |
|---|---|---|
| Collagen hydrolyzed peptidesDissolved in flavoured water, single dose, 10 g | Dietary supplement | Collagen hydrolysate, Collagen hydrolysate II |
| PlaceboSingle dose | Other | Placebo |
Primary outcome
Glucose iAUC
Time frame: 0-180 minutes postprandially
Area under the curve (AUC) calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration: Glucose-iAUC(0-180minutes)
14 secondary outcomes
Glucose Cmax
Time frame: 0-180 minutes postprandially
Delta Cmax
Time frame: 0-180 minutes postprandially
Tmax
Time frame: 0-180 minutes postprandially
Fasting glucose
Time frame: -30 minutes and 0 minutes prior mixed meal
Glucose
Time frame: 120 minutes
Fasting insulin
Time frame: -30 minutes and 0 minutes prior to mixed meal
Insulin iAUC
Time frame: 0-180 minutes postprandially
Fasting C-peptide
Time frame: -30 minutes and 0 minutes prior mixed meal
C-peptide iAUC
Time frame: 0-180 minutes postprandially
GLP-1 iAUC
Time frame: 0-120 minutes postprandially
Fasting GLP-1
Time frame: -30 minutes and 0 minutes prior mixed meal
Matsuda-Index
Time frame: 0-120 minutes postprandially
Gastric emptying
Time frame: 0-6 hours postprandially
Satiety assessment
Time frame: 0-240 minutes postprandially
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 9 Dec 2025.
- Derived from this study: PubMed 42699069Virgilio N, Schon C, Steiner N, Schlageter V, Wilhelm M, Silva CI, Gevaert E, Prawitt J. Specific Collagen Peptides Support Postprandial Metabolic Health by Modulating Incretin Hormones, Gastric Transit, and Glycemic Control in Participants with Normoglycemia and Prediabetes. Curr Dev Nutr. 2026 Aug 8;10(9):109512. doi: 10.1016/j.cdnut.2026.109512. eCollection 2026 Sep.
- 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.
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 Collagen hydrolyzed peptides in people with Prediabetes and Normoglycemic, run by Rousselot BVBA at 1 site in Germany.
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 7 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 9 Dec 2025. 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 Germany. 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?
Glucose iAUC (time frame: 0-180 minutes postprandially). 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 NCT06789263, 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 9 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.