Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03872297
Other study ID # 2018-A02490-55
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 14, 2019
Est. completion date July 30, 2019

Study information

Verified date December 2022
Source Institut Pasteur de Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
France NutrInvest - Institut Pasteur de Lille Lille Nord

Sponsors (1)

Lead Sponsor Collaborator
Institut Pasteur de Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight of participants Weight is expressed in kilograms 0 and 3 months
Secondary Body composition par DXA analysis Fat mass is expressed in kg and percent, muscle mass in kg and percent. 0 and 3 months
Secondary Waist circumference Data are expressed in centimeters 0 and 3 months
Secondary Lipid profile in plasma Total cholesterol, HDL cholesterol, LDL cholesterol, and Triglycerides. Data are expressed in g/L and in mmol/L 0 and 3 months
Secondary Glycemia level in plasma Data are expressed in g/L and mmo/L 0 and 3 months
Secondary Insulin level in plasma Data are expressed in µU/ml 0 and 3 months
Secondary 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] 0 and 3 months
Secondary 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
0 and 3 months
Secondary Pro-inflammatory cytokines concentration Assay for TNFalpha, IL-1beta and IL-6 in plasma 0 and 3 months
Secondary Microbiota analysis Rate comparison of different bacteria families 0 and 3 months
Secondary Height centimeters 0
Secondary Body mass index kg/m² 0 and 3 months
See also
  Status Clinical Trial Phase
Completed NCT03360058 - Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care N/A
Active, not recruiting NCT05400187 - Body Composition Assessment and Smart-phone Based Counselling on Healthy Eating and Weight Management N/A
Completed NCT01731197 - Satiating Effects of Isolated Soy Proteins N/A
Recruiting NCT06147752 - Mobile Internet Healthcare and Three Disciplines Co-management Intervention for Overweight/Obese Prediabetic Patients N/A
Not yet recruiting NCT06428695 - Education Session to Improve Program Adherence N/A
Completed NCT06312917 - Effect of Physical Activity Intervention on Overweight and Obese Patients With Endometrial Cancer N/A
Completed NCT01575886 - Enhancing Teachable Moment Communication for Smoking Cessation and Weight Management N/A
Completed NCT01030354 - Effects of Protein-Enriched Meal on Liver, Kidney or Bone: a Randomized Controlled Trial Phase 2/Phase 3
Completed NCT04260997 - Effect of a Probiotic, Lactobacillus Gasseri BNR17, on Body Composition and Weight Management in Overweight Adults N/A
Enrolling by invitation NCT01511393 - An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)
Recruiting NCT05257239 - Acceptability and User Perceptions of Artificial Intelligence-based Mobile Applications Adoption for Weight Management: A Sequential Explanatory Study
Completed NCT00542009 - A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight Phase 2
Recruiting NCT05869604 - Healthy Lifestyles After Cancer for Adolescents and Young Adults: A Program to Reduce Cardiovascular Risk Factors N/A
Unknown status NCT00866151 - A to Z Study Follow-up: Collection of DNA Data From Buccal Swabs N/A
Active, not recruiting NCT05813795 - A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity Phase 3
Recruiting NCT05534386 - A Self-management Based Survivorship Intervention for Chinese Cancer Survivors N/A