ToleranceNCT06232460
An Open Label, Dose-escalation Study, Assessing the Safety and Tolerability of a Collagen Peptide
A study testing H80 in people with Tolerance, run by Rousselot BVBA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tolerance
- What is being tested?
- H80
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Consuming collagen supplements (e.g., for bone and joint health and/or skin) within 2 weeks prior to Visit 2.
- Taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results including regular NSAIDs within 2 weeks prior to Visit 2.
- Has a significant acute or chronic coexisting illness or any health conditions that would prevent them from fulfilling the study requirement, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.
- Has a major or active gastrointestinal disorder including gastrointestinal bleeding within the past 3 months or chronic infective disease, or with a history of such diseases or major gastrointestinal or colonic surgery (such us, gastric bypass or any other obesity or metabolic interventions including endoscopic procedures or devices, any gastro-intestinal or colonic resection); cholecystectomy and appendectomy are allowed.
- Severe or uncontrolled cardiovascular disease (cardiovascular disease) in the 12 weeks prior to Visit 1, such as coronary artery disease (coronary artery disease), myocardial ischemia (myocardial ischemia), NYHA class IV myocardial failure, cerebrovascular disease, or peripheral artery disease.
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- Participants may not be participating in other clinical studies.
- Has received treatment involving experimental drugs in the 4 weeks prior to Visit 1.
- Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their immediate family member or a member of their household.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Tolerance
- Being tested
- H80
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H80Dietary supplement
5g, 10g \& 20g
| Study group | Role | What they receive |
|---|---|---|
| H80 - Collagen Peptides | Experimental | 5g, 10g and 20g dose escalation Receives: Dietary Supplement: H80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Change in safety blood profile
Measured: 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
Change in safety blood profile
Measured: 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
Change in vital signs (systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
Measured: 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
Change in vital signs (systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
Measured: 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
Change in heart rate (BPM)
Measured: 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 - Heart rate
Change in heart rate (BPM)
Measured: 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 - Temperature
Change in temperature (degrees Celsius)
Measured: 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 - Temperature
Change in temperature (degrees Celsius)
Measured: Baseline to Week 4, Week 8, and Week 12
To evaluate gastrointestinal symptoms in the healthy group.
Change in composite score (bloating score + abdominal cramping score + stomach noises score + flatulence score) as reported in the daily eDiary, between doses (5 g, 10 g and 20 g). Participants rate each symptom on a 0-5 scale (0 = no symptoms; 5 = severe symptoms). A sum of each of the symptom scores is calculated minimum possible score is 0 and maximum is 30. Higher scores indicate worsening Gastrointestinal symptoms.
Measured: Baseline to Week 4, Week 8, and Week 12 (Change in baseline will be defined during the 1-week run in period prior to Visit 2.)
To evaluate gastrointestinal symptoms in the pre-diabetic group.
Change in composite score (bloating score + abdominal cramping score + stomach noises score + flatulence score) as reported in the daily eDiary, between doses (5 g, 10 g and 20 g). Participants rate each symptom on a 0-5 scale (0 = no symptoms; 5 = severe symptoms). A sum of each of the symptom scores is calculated minimum possible score is 0 and maximum is 30. Higher scores indicate worsening Gastrointestinal symptoms.
Measured: Baseline to Week 4, Week 8, and Week 12 (Change in baseline will be defined during the 1-week run in period prior to Visit 2.)
To evaluate Gastrointestinal Symptom Rating Scale (GSRS) total score in the healthy group
Change in GSRS total score - Gastrointestinal symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS).The GSRS is a 15 items questionnaire combined into five symptom clusters i.e Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.(GSRS) at baseline and at week 12.
Measured: Baseline to Week 4, Week 8, and Week 12
To evaluate Gastrointestinal Symptom Rating Scale (GSRS) total score in the pre-diabetic group
Change in GSRS total score - Gastrointestinal symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS).The GSRS is a 15 items questionnaire combined into five symptom clusters i.e Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.(GSRS) at baseline and at week 12.
Measured: Baseline to Week 4, Week 8, and Week 12
Incidence of serious adverse events
Incident per dose
Measured: Baseline to week 12
Incidence of product interruption
Incidence per dose and group (healthy and pre-diabetic)
Measured: Baseline to week 12
Incidence of product discontinuation
Incidence per dose and group (healthy and pre-diabetic)
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start8 Feb 2024
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open label, dose escalation, parallel study in two groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rousselot BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacey Boetto, DNP, FNP-C, Principal investigator, Atlantia Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232460
- Sponsor's protocol ID
- AFCRO-174
- Status last verified
- Aug 2024
- First submitted
- 11 Jan 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose-escalation Study, Assessing the Safety and Tolerability of a Collagen Peptide
- ClinicalTrials.gov ID
- NCT06232460
- Acronym / sponsor ID
- AFCRO-174
- Conditions
- Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rousselot BVBAIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open label, dose escalation, parallel study in two groups
| Arm | Type | Receives |
|---|---|---|
| H80 - Collagen Peptides | Experimental | Dietary Supplement: H805g, 10g and 20g dose escalation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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:
- Are hypersensitive to any of the components of the Study Product.
- Has taken antibiotics within the 4 weeks prior to Visit 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H805g, 10g \& 20g | Dietary supplement | H80 - Collagen Peptides |
Primary outcome
To evaluate the safety and tolerability of three different doses (5 g, 10 g and 20 g) of H80 in healthy adults
Time frame: 12 weeks
Occurrence of adverse events
To evaluate the safety and tolerability of three different doses (5 g, 10 g and 20 g) of H80 in pre-diabetic adults
Time frame: 12 weeks
Occurrence of adverse events
15 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 - Heart rate
Time frame: 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 - Temperature
Time frame: 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 - Temperature
Time frame: Baseline to Week 4, Week 8, and Week 12
To evaluate gastrointestinal symptoms in the healthy group.
Time frame: Baseline to Week 4, Week 8, and Week 12 (Change in baseline will be defined during the 1-week run in period prior to Visit 2.)
To evaluate gastrointestinal symptoms in the pre-diabetic group.
Time frame: Baseline to Week 4, Week 8, and Week 12 (Change in baseline will be defined during the 1-week run in period prior to Visit 2.)
To evaluate Gastrointestinal Symptom Rating Scale (GSRS) total score in the healthy group
Time frame: Baseline to Week 4, Week 8, and Week 12
To evaluate Gastrointestinal Symptom Rating Scale (GSRS) total score in the pre-diabetic group
Time frame: Baseline to Week 4, Week 8, and Week 12
Incidence of serious adverse events
Time frame: Baseline to week 12
Incidence of product interruption
Time frame: Baseline to week 12
Incidence of product discontinuation
Time frame: Baseline to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey Boetto, DNP, FNP-C principal investigator
Atlantia Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H80 in people with Tolerance, run by Rousselot BVBA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of three different doses (5 g, 10 g and 20 g) of H80 in healthy adults (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.