Weight ManagementNATICOLNCT03872297
Fish Collagen Peptide Food Supplement on Weight and Body Composition
A study testing Naticol supplement in people with Weight Management and Food Complement, run by Institut Pasteur de Lille at 1 site in France.
Trial summary
Fish collagen hydrolysates or peptides orally administered have been investigated in recent clinical trials in human health. These peptides have been evaluated in various biological and medical fields including skin aging, osteoarticular apparatus, muscle and more recently in energy metabolism in both animals and… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Management, Food Complement
- What is being tested?
- Naticol supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2019to 30 Jul 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men in overweight (BMI between 25kg/m² and 30kg/m²)
- Aged from 18 and 60 years
- Having signed the informed consent form;
- Susceptible to follow the constraints generated by the study;
Who cannot join
- Subject treated for type 1 or 2 diabetes, or for any other metabolic disorder (severe dyslipidemia: TG> 3 g / L and total cholesterol> 2.5 g / L);
- Subject with untreated and uncorrected high blood pressure;
- Subject with untreated or uncorrected dysthyroidism by drug therapy;
- Subject with a serious general illness that may prevent his or her ability to complete the trial or that could bias the results of the study;
- Subject consuming antibiotic treatment in the month prior to inclusion;
- Subject treated with steroidal anti-inflammatory drugs, anabolic steroids, anticoagulants or corticosteroids;
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- Subject knowing allergy to fish or fish collagen;
- Subject taking any dietary supplement or drug that may interact with the results of the study or that could alter the bioavailability of the product under study;
- Subject following or having followed a low-calorie diet (energy intake <1500 kcal / day) in the 3 months preceding inclusion and / or likely to undertake this diet during the test;
- Subject having lost more than 5% of his initial weight during the last 3 months;
- Subject following a special diet: eg. vegetarian, macrobiotic diet, high protein diet;
- Subject with diagnosed eating disorders (anorexia, bulimia);
- Subject with gastrointestinal malabsorption such as celiac disease, Crohn's disease or lactose intolerance;
- Subject having undergone bariatric surgery;
- Subject with excessive alcohol consumption at more than 3 drinks a day ;
- Subject planning to modify his tobacco consumption (eg weaning) or his level of physical activity (significant increase) before the end of the intervention period;
- Subject having an aversion to the grapefruit aroma;
- Subject unable to understand or adhere to the protocol;
- Subject participating in another clinical study or exclusion period from another study;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Fish Collagen Peptide Food Supplement on the Weight and Body Composition of Healthy Volunteers in Overweight
Fish collagen hydrolysates or peptides orally administered have been investigated in recent clinical trials in human health. These peptides have been evaluated in various biological and medical fields including skin aging, osteoarticular apparatus, muscle and more recently in energy metabolism in both animals and humans.
However, very few studies investigated the effect of fish collagen peptides on weight, body composition or glycemic response. Recently, it has been shown that the consumption of fish collagen peptides (Naticol®) limits weight gain and increase in fat mass in a mouse model made obese by a hyperlipidic diet. Since these results have never been observed in humans, this pilot study proposes to answer this question.
- Conditions
- Weight Management, Food Complement
- Being tested
- Placebo supplement, Naticol supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo supplementDietary supplement
Consumption of a non active food complement during 3 months.
Tests performed :
- 2 blood tests :
- 2 body composition analysis via Dual-energy X-ray absorptiometry (DXA)
- 2 stool collections The first one of these analysis was performed at the beginning, second at the end of the study.
Naticol supplementDietary supplement
Consumption of the active food complement during 3 months containing Naticol.
Tests performed :
- 2 blood tests :
- 2 body composition analysis via Dual-energy X-ray absorptiometry (DXA)
- 2 stool collections The first one of these analysis was performed at the beginning, second at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Placebo supplement | Placebo comparator | Consumption of a non active food complement during 3 months. Receives: Dietary Supplement: Placebo supplement |
| Naticol supplement | Active comparator | Consumption of the active food complement during 3 months containing Naticol. Receives: Dietary Supplement: Naticol supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight of participants
Weight is expressed in kilograms
Measured: 0 and 3 months
Secondary outcomes (11)
Body composition par DXA analysis
Fat mass is expressed in kg and percent, muscle mass in kg and percent.
Measured: 0 and 3 months
Waist circumference
Data are expressed in centimeters
Measured: 0 and 3 months
Lipid profile in plasma
Total cholesterol, HDL cholesterol, LDL cholesterol, and Triglycerides. Data are expressed in g/L and in mmol/L
Measured: 0 and 3 months
Glycemia level in plasma
Data are expressed in g/L and mmo/L
Measured: 0 and 3 months
Insulin level in plasma
Data are expressed in μU/ml
Measured: 0 and 3 months
HOMA index
This index indicates the insulin resistance and was calculated as follow : HOMA [(glycémie mmol/l X insulinémie μU/ml) à jeun / 22,5]
Measured: 0 and 3 months
Physical activity intensity
Score obtained via Ricci and Gagnon questionnaire. The questionnaire contains 9 questions ; score could be between 9 and 45 points.
- under 18 points : inactive behavior
- between 19 and 35 points : active behavior
- over 35 points : very active behavior
Measured: 0 and 3 months
Pro-inflammatory cytokines concentration
Assay for TNFalpha, IL-1beta and IL-6 in plasma
Measured: 0 and 3 months
Microbiota analysis
Rate comparison of different bacteria families
Measured: 0 and 3 months
Height
centimeters
Measured: 0
Body mass index
kg/m²
Measured: 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start14 Jan 2019
- Primary completion30 Jun 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Jean-Michel LECERF, MD, Principal investigator, Institut Pasteur de Lille - NutrInvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872297
- Sponsor's protocol ID
- 2018-A02490-55
- Acronym
- NATICOL
- Status last verified
- Dec 2022
- First submitted
- 11 Mar 2019
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Fish Collagen Peptide Food Supplement on the Weight and Body Composition of Healthy Volunteers in Overweight
- ClinicalTrials.gov ID
- NCT03872297
- Acronym / sponsor ID
- NATICOL / 2018-A02490-55
- Conditions
- Weight Management, Food Complement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 13 Mar 2019 (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.
Fish collagen hydrolysates or peptides orally administered have been investigated in recent clinical trials in human health. These peptides have been evaluated in various biological and medical fields including skin aging, osteoarticular apparatus, muscle and more recently in energy metabolism in both animals and humans.
However, very few studies investigated the effect of fish collagen peptides on weight, body composition or glycemic response. Recently, it has been shown that the consumption of fish collagen peptides (Naticol®) limits weight gain and increase in fat mass in a mouse model made obese by a hyperlipidic diet. Since these results have never been observed in humans, this pilot study proposes to answer this question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo supplement | Placebo comparator | Dietary Supplement: Placebo supplementConsumption of a non active food complement during 3 months. |
| Naticol supplement | Active comparator | Dietary Supplement: Naticol supplementConsumption of the active food complement during 3 months containing Naticol. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men in overweight (BMI between 25kg/m² and 30kg/m²)
- Aged from 18 and 60 years
- Having signed the informed consent form;
- Susceptible to follow the constraints generated by the study;
Key exclusion criteria (19 listed)
- Subject treated for type 1 or 2 diabetes, or for any other metabolic disorder (severe dyslipidemia: TG> 3 g / L and total cholesterol> 2.5 g / L);
- Subject with untreated and uncorrected high blood pressure;
- Subject with untreated or uncorrected dysthyroidism by drug therapy;
- Subject with a serious general illness that may prevent his or her ability to complete the trial or that could bias the results of the study;
- Subject consuming antibiotic treatment in the month prior to inclusion;
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 |
|---|---|---|
| Placebo supplementConsumption of a non active food complement during 3 months. Tests performed : * 2 blood tests : * 2 body composition analysis via Dual-energy X-ray absorptiometry (DXA) * 2 stool collections The first one of these analysis was performed at the beginning, second at the end of the study. | Dietary supplement | Placebo supplement |
| Naticol supplementConsumption of the active food complement during 3 months containing Naticol. Tests performed : * 2 blood tests : * 2 body composition analysis via Dual-energy X-ray absorptiometry (DXA) * 2 stool collections The first one of these analysis was performed at the beginning, second at the end of the study. | Dietary supplement | Naticol supplement |
Primary outcome
Weight of participants
Time frame: 0 and 3 months
Weight is expressed in kilograms
11 secondary outcomes
Body composition par DXA analysis
Time frame: 0 and 3 months
Waist circumference
Time frame: 0 and 3 months
Lipid profile in plasma
Time frame: 0 and 3 months
Glycemia level in plasma
Time frame: 0 and 3 months
Insulin level in plasma
Time frame: 0 and 3 months
HOMA index
Time frame: 0 and 3 months
Physical activity intensity
Time frame: 0 and 3 months
Pro-inflammatory cytokines concentration
Time frame: 0 and 3 months
Microbiota analysis
Time frame: 0 and 3 months
Height
Time frame: 0
Body mass index
Time frame: 0 and 3 months
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 7 Dec 2022.
- 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.
Jean-Michel LECERF, MD principal investigator
Institut Pasteur de Lille - NutrInvest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naticol supplement in people with Weight Management and Food Complement, run by Institut Pasteur de Lille at 1 site in France.
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 4 inclusion and 19 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 7 Dec 2022. 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 France. 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. Some participants in this study may receive a placebo. 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?
Weight of participants (time frame: 0 and 3 months). 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 7 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.