Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brown Seaweed Extract on Glycemic Control and Body Weight (Algues)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03075943
Recruitment Status : Unknown
Verified January 2019 by Helene Jacques, Laval University.
Recruitment status was:  Active, not recruiting
First Posted : March 9, 2017
Last Update Posted : January 10, 2019
Sponsor:
Collaborators:
Ministry of Agriculture, Fisheries and Food, Quebec
innoVactiv Inc.
Information provided by (Responsible Party):
Helene Jacques, Laval University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The overall goal of this study is to investigate the effects of a daily dietary supplement of brown seaweed (2 capsules of InSea2®) on body weight, glycemic control and insulin secretion in overweight prediabetic men and women in association with a moderate weight loss intervention.

Condition or disease Intervention/treatment Phase
PreDiabetes Insulin Resistance Dietary Supplement: InSea2 Dietary Supplement: Placebo Not Applicable

Detailed Description:

Diets that produce lower glucose and insulin responses may reduce diabetes and cardiovascular risk. They may also facilitate weight control by promoting satiety, insulin sensitivity and optimal insulin secretion after a meal. Food ingredients may indeed reduce postprandial glucose and insulin response through an inhibition of α-amylase and α-glucosidase activity that may slow down the absorption of carbohydrates. InSea2® is a unique combination of polyphenolic extracts of brown algae (Ascophyllum nodosum and Fucus vesiculosus) which has been shown to inhibit the action of α-amylase and α-glucosidase. Preliminary data in healthy men and women have demonstrated a reducing effect on plasma insulin of a single intake of InSea2® consumed with a high-carbohydrate meal.

The main objective is to evaluate the effects of a daily dietary supplement of 500 mg (2 capsules) of brown algae extract powder (InSea2®) on blood glucose measured 2 hours after an oral glucose tolerance test (OGTT) in overweight insulin-resistant men and women.

The secondary objectives are to assess the contribution of a daily consumption of this supplement (InSea2®) on weight loss when associated with a daily caloric restriction of 500 kcal due to individualized nutritional intervention. More specifically, the investigators aim to evaluate the effects of supplementation combined with weight loss on other markers of glucose metabolism (fasting plasma glucose, glucose and insulin response during OGTT, insulin sensitivity measurement parameters and insulin secretion during OGTT), lipid profile, blood pressure and metabolic syndrome criteria.

The investigators expect that InSea2® lowers the high levels of blood glucose and insulin observed 2 hours after a meal in overweight insulin-resistant human subjects.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of a Brown Seaweed Extract on Glycemic Control and Body Weight in Overweight Pre-diabetic Subjects.
Actual Study Start Date : December 2016
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: InSea2
2 capsules/day of InSea2 administered 30 min before a meal (breakfast, lunch or diner) combined with weight loss program (individualized nutritional intervention with a daily restriction of 500 kcal)
 Dietary Supplement: InSea2
Daily supplement: 2 capsules of InSea2
Other Name: Brown seaweed extract supplement
Placebo Comparator: Placebo
2 capsules/day of Placebo administered 30 min before a meal (breakfast, lunch or diner) combined with weight loss program (individualized nutritional intervention with a daily restriction of 500 kcal)
 Dietary Supplement: Placebo
Daily supplement: 2 capsules of Placebo
Other Name: Control


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in glucose metabolism [ Time Frame: at baseline and at the end of the intervention (12 week) ]

Secondary Outcome Measures :
  1. Change in insulin secretion [ Time Frame: at baseline and at the end of the intervention (12 week) ]
  2. Change in body weight [ Time Frame: at baseline and at the end of the intervention (12 week) ]
  3. Change in body lean mass distribution [ Time Frame: at baseline and at the end of the intervention (12 week) ]
  4. Change in body fat mass distribution [ Time Frame: at baseline and at the end of the intervention (12 week) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • overweight (BMI > 25; waist circumference ≥ 80cm for women and ≥ 94 cm for men)
  • fasting insulin ≥ 60 pmol/L)
  • Impaired fasting glycemia with or without impaired glucose tolerance
  • HbA1c between 5.6 and 6.4
  • non-smoking
  • stable weight in the past 3 months

Exclusion Criteria:

  • diabetes
  • chronic disease (thyroid dysfunction, hepatic or gastrointestinal disorder, uncontrolled hypertension)
  • taking drugs that could affect glucose or lipid metabolism or weight and appetite
  • taking dietary supplements or natural health products that could affect glucose, lipid, weight or appetite
  • major surgery 3 months prior to the study
  • past surgery of the digestive system
  • pregnancy
  • fish, seafood or iodine allergy
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03075943


Locations
Layout table for location information
Canada
Institute of Nutrition and Functional Foods (INAF), Laval University
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Ministry of Agriculture, Fisheries and Food, Quebec
innoVactiv Inc.
Investigators
Layout table for investigator information
Principal Investigator: Hélène Jacques, PhD Institue of Nutrition and Functional Food (INAF), Laval University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Helene Jacques, Professor, Laval University
ClinicalTrials.gov Identifier: NCT03075943    
Other Study ID Numbers: ALGUES 2016-227
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Body Weight
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases