Loading clinical trials...

COMPLETEDNA

An Open Label, Dose-escalation Study, Assessing the Safety and Tolerability of a Collagen Peptide

NCT06232460•Rousselot BVBA

Summary

This study evaluates the safety and tolerability of three different doses (5 g, 10 g and 20 g) of a collagen powder in healthy adults over a 12-week period.

Detailed Description

This study evaluates the safety and tolerability of three different doses (5 g, 10 g and 20 g) of a collagen powder, each for 4-weeks in healthy adults over a 12-week period by measuring occurrence of adverse events, safety blood panel, vital signs, occurrence of common gastrointestinal symptom's and the Gastrointestinal Symptom Rating Scale

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Be able to give written informed consent.
•2. Be aged ≥18 and ≤60 years.
•3. HbA1c between 5.7% and 6.4% and/or fasting glucose between 100 mg/dL and 125 mg/dL (Fasting glucose will be confirmed at Visit 1.2 if HbA1c is \<5.7%) for pre-diabetic group ONLY.
•4. Is in general good health, as determined by the investigator.
•5. Willing to consume the Study Product daily for the duration of the study and comply with study procedures for the duration.

Exclusion Criteria

•1. Participants who are pregnant or wish to become pregnant during the study.
•2. Participants who are lactating and/or currently breastfeeding.
•3. Participants currently of childbearing potential, but not using a continuous effective method of contraception, as outlined below:
•1. Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
•2. Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
•3. Sexual partner(s) is/are exclusively female.
•4. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
•5. Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
•4. Are hypersensitive to any of the components of the Study Product.
•5. Has taken antibiotics within the 4 weeks prior to Visit 1.
+14 more criteria

Locations (1)

Atlantia Clinical Trials

Chicago, Illinois, United States

Key Dates

Start Date

February 8, 2024

Primary Completion Date

July 29, 2024

Completion Date

July 29, 2024

Last Updated

May 9, 2025

Enrollment

ACTUAL participants

Conditions

Tolerance

Interventions

H80

DIETARY_SUPPLEMENT

Acute Effects of LLLT on Pain Threshold and Pain Tolerance

NCT07422272

Pain ThresholdPain Tolerance+3 more

View study

RECRUITINGPHASE2/PHASE3

Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance

NCT06603883

Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Open Label, Dose-escalation Study, Assessing the Safety and Tolerability of a Collagen Peptide

Inclusion Criteria

Exclusion Criteria

Acute Effects of LLLT on Pain Threshold and Pain Tolerance

Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance

Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes

Delayed Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-matched Kidney Transplants

Goat vs. Cow Milk Digestive Tolerance

Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer.