Could collagen supplements tame blood sugar spikes?
NCT ID NCT05887791
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This study investigates whether a single dose of collagen hydrolysate, a dietary supplement, can reduce the rise in blood sugar and insulin after a meal. Researchers are testing two different doses in both prediabetic and healthy adults. The trial uses a double-blind, placebo-controlled, crossover design, meaning each participant receives both the supplement and a placebo at different times, and neither they nor the researchers know which is which.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- collagen hydrolysate (a dietary supplement derived from collagen)
- What this could lead to
- If it works, this could point toward a simple dietary supplement to help manage blood sugar after meals, potentially aiding prediabetes management.
- What could go wrong
- This is a small, early-stage trial with only 16 participants, so results may not apply broadly. The effect may be small or not clinically meaningful.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
16 people
The number who actually took part.
- Started
-
Jun 2023
- Finished
-
Apr 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
BioTeSys GmbH
Esslingen am Neckar, 73728, Germany
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