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Fish Collagen Peptide Food Supplement on Weight and Body Composition (NATICOL)

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ClinicalTrials.gov Identifier: NCT03872297
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jean-Michel Lecerf, Institut Pasteur de Lille

Brief 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 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.


Condition or disease Intervention/treatment Phase
Weight Management Food Complement Dietary Supplement: Placebo supplement Dietary Supplement: Naticol supplement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Fish Collagen Peptide Food Supplement on the Weight and Body Composition of Healthy Volunteers in Overweight
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo supplement
Consumption of a non active food complement during 3 months.
Dietary Supplement: Placebo 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.

Active Comparator: Naticol supplement
Consumption of the active food complement during 3 months containing Naticol.
Dietary Supplement: Naticol 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.




Primary Outcome Measures :
  1. Weight of participants [ Time Frame: 0 and 3 months ]
    Weight in kilograms


Secondary Outcome Measures :
  1. Body composition par DXA analysis [ Time Frame: 0 and 3 months ]
    Fat mass in kg and percent. Muscle mass in kg and percent.

  2. Waist circumference [ Time Frame: 0 and 3 months ]
    data in centimeters

  3. Lipid and glycemic profile in plasma [ Time Frame: 0 and 3 months ]
    Total cholesterol, HDL cholesterol, LDL cholesterol, Triglycerides, Glycemia, insulin, HOMA index

  4. Physical activity intensity [ Time Frame: 0 and 3 months ]

    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

  5. Pro-inflammatory cytokines concentration [ Time Frame: 0 and 3 months ]
    Assay for TNFalpha, IL-1beta and IL-6 in plasma

  6. Microbiota analysis [ Time Frame: 0 and 3 months ]
    Rate comparison of different bacteria families



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   To avoid action of femal hormone, this pilot study is based on male population
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
  • 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872297


Contacts
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Contact: Coralie BERTHIER, PhD 03.20.87.73.33 ext +33 coralie.berthier@pasteur-lille.fr

Locations
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France
NutrInvest - Institut Pasteur de Lille Recruiting
Lille, Nord, France, 59019
Contact: Coralie Berthier, PhD    +33 (0)3 20 87 73 33    coralie.berthier@pasteur-lille.frteur-lille.fr   
Principal Investigator: Jean-Michel Lecerf, MD         
Sponsors and Collaborators
Institut Pasteur de Lille
Investigators
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Principal Investigator: Jean-Michel LECERF, MD Institut Pasteur de Lille - NutrInvest

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Responsible Party: Jean-Michel Lecerf, MD in nutrion and endocrinology, Institut Pasteur de Lille
ClinicalTrials.gov Identifier: NCT03872297     History of Changes
Other Study ID Numbers: 2018-A02490-55
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs