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

R

Rousselot

Status

Completed

Conditions

Prediabetic State
Healthy

Treatments

Dietary Supplement: Collagen hydrolysate
Other: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05887791
BTS1984/23

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

15 participants in 3 patient groups, including a placebo group

Collagen hydrolysate dose 1
Experimental group
Description:
Source: porcine; standardized to 10 g provided as single dose. Orally applied in flavoured water.
Treatment:
Dietary Supplement: Collagen hydrolysate
Collagen hydrolysate dose 2
Experimental group
Description:
Source: porcine; standardized to 5 g provided as single dose. Orally applied in flavoured water.
Treatment:
Dietary Supplement: Collagen hydrolysate
Placebo
Placebo Comparator group
Description:
Flavoured water
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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