Brown Seaweed Extract on Glycemic Control and Body Weight

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of a Brown Seaweed Extract on Glycemic Control and Body Weight in Overweight Pre-diabetic Subjects.

Conditions
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PreDiabetes, Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: InSea2
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InSea2<br>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<br>* Daily supplement: 2 capsules of InSea2<br>* Other names: Brown seaweed extract supplement;|
| Placebo Comparator: Placebo<br>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<br>* Daily supplement: 2 capsules of Placebo<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood glucose (mmol/L) | glucose in the fasting state and during a 2h-OGTT | at baseline and at the end of the intervention (12 week) | 
| Changes in blood insulin (pmol/L) and C-peptide (pmol/L) | insulin and C-peptide in the fasting state and during a 2h-OGTT | at baseline and at the end of the intervention (12 week) | 
| Changes in anthropometrics | body weight (kg), lean mass (kg) and fat mass (kg) | at baseline and at the end of the intervention (12 week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood pressure | Systolic and diastolic blood pressure (mmHg) | at baseline and at the end of the intervention (12 week) | 
| Changes in heart rate | Heart rate (n/min) | at baseline and at the end of the intervention (12 week) | 
| Changes in lipid profile | cholesterol (mmol/L), triglycerides (mmol/L), LDLc (mmol/L), HDLc (mmol/L) | at baseline and at the end of the intervention (12 week) | 
| Changes in hsCRP | HsCRP (mg/L) | at baseline and at the end of the intervention (12 week) | 
| Changes in Il-6 | IL-6 (pg/L) | at baseline and at the end of the intervention (12 week) | 
| Changes in marker of oxidative stress | F2-isoprostane (ng/mL) | at baseline and at the end of the intervention (12 week) | 
| Changes in markers of gut barrier integrity | LBP (ng/mL), zonulin (ng/mL) | at baseline and at the end of the intervention (12 week) |