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

NCT06232460 | Completed

• 1 other identifier: AFCRO-174
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tolerance

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of three different doses (5 g, 10 g and 20 g) of H80 in healthy adults

  Occurrence of adverse events

  12 weeks

• To evaluate the safety and tolerability of three different doses (5 g, 10 g and 20 g) of H80 in pre-diabetic adults

  Occurrence of adverse events

  12 weeks

Secondary Outcomes (15)

• To evaluate the safety and tolerability of three different doses (5 g, 10 g and 20 g) of H80 in healthy adults- Safety blood profile

  Baseline to Week 4, Week 8, and Week 12

• To evaluate the safety and tolerability of three different doses (5 g, 10 g and 20 g) of H80 in pre-diabetic adults - Safety blood profile

  Baseline to Week 4, Week 8, and Week 12

• To evaluate the safety and tolerability of three different doses (5 g, 10 g and 20 g) of H80 in healthy adults - Vital Signs - Blood Pressure

  Baseline to Week 4, Week 8, and Week 12

• To evaluate the safety and tolerability of three different doses (5 g, 10 g and 20 g) of H80 in pre-diabetic adults - Vital Signs - Blood Pressure

  Baseline to Week 4, Week 8, and Week 12

• To evaluate the safety and tolerability of three different doses (5 g, 10 g and 20 g) of H80 in healthy adults - Vital Signs - Heart rate

  Baseline to Week 4, Week 8, and Week 12

Study Arms (1)

H80 - Collagen Peptides

EXPERIMENTAL

5g, 10g and 20g dose escalation

Dietary Supplement: H80

Interventions

H80 DIETARY_SUPPLEMENT

5g, 10g \& 20g

H80 - Collagen Peptides

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be able to give written informed consent.
• Be aged ≥18 and ≤60 years.
• 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.
• Is in general good health, as determined by the investigator.
• Willing to consume the Study Product daily for the duration of the study and comply with study procedures for the duration.

You may not qualify if:

• Participants who are pregnant or wish to become pregnant during the study.
• Participants who are lactating and/or currently breastfeeding.
• Participants currently of childbearing potential, but not using a continuous effective method of contraception, as outlined below:
• 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).
• Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
• Sexual partner(s) is/are exclusively female.
• 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.
• 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.
• Are hypersensitive to any of the components of the Study Product.
• Has taken antibiotics within the 4 weeks prior to Visit 1.
• Vegetarians not willing to consume collagen of porcine origin.
• Chronic usage of any medication that in the opinion of the investigator would impact gut motility 2 weeks prior to Visit 2.
• Diagnosis of Type I diabetes.
• Prior diagnosis of Type II diabetes and has received treatment in the 12 weeks prior to Visit 1.
• Active infectious disease in the 4 weeks prior to Visit 1.

Sponsors & Collaborators

• Rousselot BVBA: lead

Study Sites (1)

Atlantia Clinical Trials

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Prenalterol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Stacey Boetto, DNP, FNP-C

  Atlantia Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open label, dose escalation, parallel study in two groups

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 30, 2024
• Study Start: February 8, 2024
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: May 9, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)