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HealthyNCT05887791

Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile in Prediabetic and Healthy Subjects

A study testing Collagen hydrolysate in people with Healthy and Prediabetic State, run by Rousselot BVBA at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the effect of two different dosages collagen hydrolysate (CH) on postprandial blood glucose and insulin profile in prediabetic and normo-glycaemic subjects.This will be investigated in a cross-over randomized double-blind placebo controlled study design. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Prediabetic State
What is being tested?
Collagen hydrolysate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteGermany
Study dates
15 Jun 2023to 1 Apr 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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Main Inclusion Criteria:

  • 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 normo-glycaemic 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

Main Exclusion Criteria:

  • 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)
  • Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • BioTeSys GmbH

    Esslingen am Neckar, 73728

Other trials in Germany

About this study

Official title: Clinical Study to Assess the Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile in Prediabetic and Healthy Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages

To investigate the effect of two different dosages collagen hydrolysate (CH) on postprandial blood glucose and insulin profile in prediabetic and normo-glycaemic subjects.This will be investigated in a cross-over randomized double-blind placebo controlled study design.

Being tested
Collagen hydrolysate, Placebo
Keywords
collagen peptides, blood sugar modifying
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 hydrolysateDietary supplement

    Single dose

  • PlaceboOther

    Single dose

Study groups in NCT05887791
Study groupRoleWhat they receive
Collagen hydrolysate dose 1ExperimentalSource: porcine; standardized to 10 g provided as single dose. Orally applied in flavoured water.
Receives: Dietary Supplement: Collagen hydrolysate
Collagen hydrolysate dose 2ExperimentalSource: porcine; standardized to 5 g provided as single dose. Orally applied in flavoured water.
Receives: Dietary Supplement: Collagen hydrolysate
PlaceboPlacebo comparatorFlavoured water
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (10)

  1. Glucose iAUC

    Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration: Glucose-iAUC(0-240minutes)

    Measured: 0-240 minutes postprandially

  2. Glucose Cmax

    Maximum blood glucose concentration (Cmax)

    Measured: 0-180 minutes postprandially

  3. Delta Cmax

    Maximum increase of blood glucose concentration

    Measured: 0-180 minutes postprandially

  4. Tmax

    Time to reach maximum blood glucose concentration (Tmax)

    Measured: 0-180 minutes postprandially

  5. T baseline

    First time to reach baseline again after increase or decrease in blood glucose

    Measured: 0-240 minutes postprandially

  6. Matsuda-Index

    Determination of Insulin sensitivity

    Measured: 0-120 minutes postprandially

  7. Glucose dip

    maximum dip below baseline and time point of glucose dip

    Measured: 0-240 minutes postprandially

  8. Insulin iAUC

    Area under the curve calculated as the incremental area under the insulin curve

    Measured: up to 0-240 minutes postprandially

  9. GLP-1

    Incretin response (Glucagon-like Peptide-1)

    Measured: 0-120 minutes postprandially

  10. 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.

  1. First posted5 Jun 2023
  2. Study start15 Jun 2023
  3. Primary completion23 Dec 2023
  4. Study completion1 Apr 2024

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05887791
Sponsor's protocol ID
BTS1984/23
Status last verified
Jun 2023
First submitted
24 May 2023
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Collagen hydrolysate in people with Healthy and Prediabetic State, 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?

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 20 Jul 2026. 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 NCT05887791.

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 20 Jul 2026.

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