NCT05887791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

December 17, 2024

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

May 24, 2023

Last Update Submit

December 16, 2024

Conditions

HealthyPrediabetic State

Keywords

collagen peptidesblood sugar modifying

Outcome Measures

Primary Outcomes (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)

    0-180 minutes postprandially

Secondary Outcomes (10)

  • Glucose iAUC

    0-240 minutes postprandially

  • Glucose Cmax

    0-180 minutes postprandially

  • Delta Cmax

    0-180 minutes postprandially

  • Tmax

    0-180 minutes postprandially

  • T baseline

    0-240 minutes postprandially

  • +5 more secondary outcomes

Other Outcomes (2)

  • Gastrointestinal hormones

    0-120 minutes postprandially

  • Amino acids

    0-240 minutes postprandially

Study Arms (3)

Collagen hydrolysate dose 1

EXPERIMENTAL

Source: porcine; standardized to 10 g provided as single dose. Orally applied in flavoured water.

Dietary Supplement: Collagen hydrolysate

Collagen hydrolysate dose 2

EXPERIMENTAL

Source: porcine; standardized to 5 g provided as single dose. Orally applied in flavoured water.

Dietary Supplement: Collagen hydrolysate

Placebo

PLACEBO COMPARATOR

Flavoured water

Other: Placebo

Interventions

Collagen hydrolysateDIETARY_SUPPLEMENT

Single dose

Collagen hydrolysate dose 1Collagen hydrolysate dose 2
PlaceboOTHER

Single dose

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nicoletta Virgilio, PhD

    Rousselot BV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 5, 2023

Study Start

June 15, 2023

Primary Completion

December 23, 2023

Study Completion

April 1, 2024

Last Updated

December 17, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)