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Brown Seaweed Extract on Glycemic Control and Body Weight

Not Applicable
Completed
Conditions
PreDiabetes
Insulin Resistance
Interventions
Dietary Supplement: InSea2
Dietary Supplement: Placebo
Registration Number
NCT03075943
Lead Sponsor
Laval University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
56
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InSea2InSea22 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)
PlaceboPlacebo2 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)
Primary Outcome Measures
NameTimeMethod
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 anthropometricsat baseline and at the end of the intervention (12 week)

body weight (kg), lean mass (kg) and fat mass (kg)

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

Secondary Outcome Measures
NameTimeMethod
Changes in marker of oxidative stressat baseline and at the end of the intervention (12 week)

F2-isoprostane (ng/mL)

Changes in markers of gut barrier integrityat baseline and at the end of the intervention (12 week)

LBP (ng/mL), zonulin (ng/mL)

Changes in blood pressureat baseline and at the end of the intervention (12 week)

Systolic and diastolic blood pressure (mmHg)

Changes in heart rateat baseline and at the end of the intervention (12 week)

Heart rate (n/min)

Changes in Il-6at baseline and at the end of the intervention (12 week)

IL-6 (pg/L)

Changes in hsCRPat baseline and at the end of the intervention (12 week)

HsCRP (mg/L)

Changes in lipid profileat baseline and at the end of the intervention (12 week)

cholesterol (mmol/L), triglycerides (mmol/L), LDLc (mmol/L), HDLc (mmol/L)

Trial Locations

Locations (1)

Institute of Nutrition and Functional Foods (INAF), Laval University

🇨🇦

Quebec, Canada

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