Brown Seaweed Extract on Glycemic Control and Body Weight (Algues)
Primary Purpose
PreDiabetes, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
InSea2
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for PreDiabetes
Eligibility 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 (protein powders, fish oil, omega-3 or any marine supplements) or natural health products that could affect glucose, lipid, weight or appetite
- major surgery 3 months prior to the study
- pregnancy
- fish, seafood or iodine allergy
Sites / Locations
- Institute of Nutrition and Functional Foods (INAF), Laval University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
InSea2
Placebo
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Changes in blood glucose (mmol/L)
glucose in the fasting state and during a 2h-OGTT
Changes in blood insulin (pmol/L) and C-peptide (pmol/L)
insulin and C-peptide in the fasting state and during a 2h-OGTT
Changes in anthropometrics
body weight (kg), lean mass (kg) and fat mass (kg)
Secondary Outcome Measures
Changes in blood pressure
Systolic and diastolic blood pressure (mmHg)
Changes in heart rate
Heart rate (n/min)
Changes in lipid profile
cholesterol (mmol/L), triglycerides (mmol/L), LDLc (mmol/L), HDLc (mmol/L)
Changes in hsCRP
HsCRP (mg/L)
Changes in Il-6
IL-6 (pg/L)
Changes in marker of oxidative stress
F2-isoprostane (ng/mL)
Changes in markers of gut barrier integrity
LBP (ng/mL), zonulin (ng/mL)
Full Information
NCT ID
NCT03075943
First Posted
March 6, 2017
Last Updated
August 12, 2022
Sponsor
Laval University
Collaborators
Ministry of Agriculture, Fisheries and Food, Quebec, innoVactiv Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03075943
Brief Title
Brown Seaweed Extract on Glycemic Control and Body Weight
Acronym
Algues
Official Title
Efficacy of a Brown Seaweed Extract on Glycemic Control and Body Weight in Overweight Pre-diabetic Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Ministry of Agriculture, Fisheries and Food, Quebec, innoVactiv Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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 body weight and blood glucose homeostasis (glucose, insulin, c-peptide) measured in the fasting state and during a 2-hour oral glucose tolerance test (OGTT) in overweight prediabetic 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 on markers of lipid profile, blood pressure, inflammation, oxidative stress and gut barrier integrity.
The investigators expect that InSea2® lowers body weight and blood glucose homeostasis (glucose, insulin or C-peptide, as marker of insulin secretion, in the fasting state or during a 2-hour oral glucose tolerance test) in association with metabolic and inflammatory markers in the context of moderate weight loss in overweight prediabetic human subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Insulin Resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
InSea2
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
InSea2
Other Intervention Name(s)
Brown seaweed extract supplement
Intervention Description
Daily supplement: 2 capsules of InSea2
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
Daily supplement: 2 capsules of Placebo
Primary Outcome Measure Information:
Title
Changes in blood glucose (mmol/L)
Description
glucose in the fasting state and during a 2h-OGTT
Time Frame
at baseline and at the end of the intervention (12 week)
Title
Changes in blood insulin (pmol/L) and C-peptide (pmol/L)
Description
insulin and C-peptide in the fasting state and during a 2h-OGTT
Time Frame
at baseline and at the end of the intervention (12 week)
Title
Changes in anthropometrics
Description
body weight (kg), lean mass (kg) and fat mass (kg)
Time Frame
at baseline and at the end of the intervention (12 week)
Secondary Outcome Measure Information:
Title
Changes in blood pressure
Description
Systolic and diastolic blood pressure (mmHg)
Time Frame
at baseline and at the end of the intervention (12 week)
Title
Changes in heart rate
Description
Heart rate (n/min)
Time Frame
at baseline and at the end of the intervention (12 week)
Title
Changes in lipid profile
Description
cholesterol (mmol/L), triglycerides (mmol/L), LDLc (mmol/L), HDLc (mmol/L)
Time Frame
at baseline and at the end of the intervention (12 week)
Title
Changes in hsCRP
Description
HsCRP (mg/L)
Time Frame
at baseline and at the end of the intervention (12 week)
Title
Changes in Il-6
Description
IL-6 (pg/L)
Time Frame
at baseline and at the end of the intervention (12 week)
Title
Changes in marker of oxidative stress
Description
F2-isoprostane (ng/mL)
Time Frame
at baseline and at the end of the intervention (12 week)
Title
Changes in markers of gut barrier integrity
Description
LBP (ng/mL), zonulin (ng/mL)
Time Frame
at baseline and at the end of the intervention (12 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 (protein powders, fish oil, omega-3 or any marine supplements) or natural health products that could affect glucose, lipid, weight or appetite
major surgery 3 months prior to the study
pregnancy
fish, seafood or iodine allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène Jacques, PhD
Organizational Affiliation
Institue of Nutrition and Functional Food (INAF), Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Nutrition and Functional Foods (INAF), Laval University
City
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada
12. IPD Sharing Statement
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Brown Seaweed Extract on Glycemic Control and Body Weight
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