Insulin Resistance, PreDiabetes
Conditions
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.
Interventions
DIETARY_SUPPLEMENTInSea2
Daily supplement: 2 capsules of InSea2
DIETARY_SUPPLEMENTPlacebo
Daily supplement: 2 capsules of Placebo
Sponsors
Ministry of Agriculture, Fisheries and Food, Quebec
innoVactiv Inc.
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood glucose (mmol/L) | at baseline and at the end of the intervention (12 week) | glucose in the fasting state and during a 2h-OGTT |
| Changes in blood insulin (pmol/L) and C-peptide (pmol/L) | at baseline and at the end of the intervention (12 week) | insulin and C-peptide in the fasting state and during a 2h-OGTT |
| Changes in anthropometrics | at baseline and at the end of the intervention (12 week) | body weight (kg), lean mass (kg) and fat mass (kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hsCRP | at baseline and at the end of the intervention (12 week) | HsCRP (mg/L) |
| Changes in Il-6 | at baseline and at the end of the intervention (12 week) | IL-6 (pg/L) |
| Changes in blood pressure | at baseline and at the end of the intervention (12 week) | Systolic and diastolic blood pressure (mmHg) |
| Changes in markers of gut barrier integrity | at baseline and at the end of the intervention (12 week) | LBP (ng/mL), zonulin (ng/mL) |
| Changes in marker of oxidative stress | at baseline and at the end of the intervention (12 week) | F2-isoprostane (ng/mL) |
| Changes in heart rate | at baseline and at the end of the intervention (12 week) | Heart rate (n/min) |
| Changes in lipid profile | at baseline and at the end of the intervention (12 week) | cholesterol (mmol/L), triglycerides (mmol/L), LDLc (mmol/L), HDLc (mmol/L) |
Countries
Canada
Outcome results
None listed