Clinical trial NCT05887791: Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile in Prediabetic and Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Prediabetic State
Keywords: collagen peptides
blood sugar modifying
Lead sponsor: Rousselot BVBA
Sponsor class: INDUSTRY
Collaborators: name: BioTeSys GmbH
First posted: 2023-06-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Glucose iAUC
timeFrame: 0-180 minutes postprandially
Secondary outcomes:
measure: Glucose iAUC
timeFrame: 0-240 minutes postprandially
measure: Glucose Cmax
timeFrame: 0-180 minutes postprandially
measure: Delta Cmax
timeFrame: 0-180 minutes postprandially
measure: Tmax
timeFrame: 0-180 minutes postprandially
measure: T baseline
timeFrame: 0-240 minutes postprandially
measure: Matsuda-Index
timeFrame: 0-120 minutes postprandially
measure: Glucose dip
timeFrame: 0-240 minutes postprandially
measure: Insulin iAUC
timeFrame: up to 0-240 minutes postprandially
measure: GLP-1
timeFrame: 0-120 minutes postprandially
measure: Satiety assessment
timeFrame: 0-240 minutes postprandially
Other outcomes:
measure: Gastrointestinal hormones
timeFrame: 0-120 minutes postprandially
measure: Amino acids
timeFrame: 0-240 minutes postprandially
Locations:
city: Esslingen
country: Germany
facility: BioTeSys GmbH
Study officials:
affiliation: Rousselot BV
name: Nicoletta Virgilio, PhD
role: STUDY_DIRECTOR
References: