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Completed

NCT Number: NCT03075943

Brown Seaweed Extract on Glycemic Control and Body Weight

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Québec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InSea2

Dietary Supplement

Daily supplement: 2 capsules of InSea2

Other names: Brown seaweed extract supplement

Placebo

Dietary Supplement

Daily supplement: 2 capsules of Placebo

Other names: Control

Primary outcomes

  1. Changes in blood glucose (mmol/L)

    Time frame: at baseline and at the end of the intervention (12 week)

    glucose in the fasting state and during a 2h-OGTT

  2. Changes in blood insulin (pmol/L) and C-peptide (pmol/L)

    Time frame: at baseline and at the end of the intervention (12 week)

    insulin and C-peptide in the fasting state and during a 2h-OGTT

  3. Changes in anthropometrics

    Time frame: at baseline and at the end of the intervention (12 week)

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

Secondary outcomes

  1. Changes in blood pressure

    Time frame: at baseline and at the end of the intervention (12 week)

    Systolic and diastolic blood pressure (mmHg)

  2. Changes in heart rate

    Time frame: at baseline and at the end of the intervention (12 week)

    Heart rate (n/min)

  3. Changes in lipid profile

    Time frame: at baseline and at the end of the intervention (12 week)

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

  4. Changes in hsCRP

    Time frame: at baseline and at the end of the intervention (12 week)

    HsCRP (mg/L)

  5. Changes in Il-6

    Time frame: at baseline and at the end of the intervention (12 week)

    IL-6 (pg/L)

  6. Changes in marker of oxidative stress

    Time frame: at baseline and at the end of the intervention (12 week)

    F2-isoprostane (ng/mL)

  7. Changes in markers of gut barrier integrity

    Time frame: at baseline and at the end of the intervention (12 week)

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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Ministry of Agriculture, Fisheries and Food, Quebec
  • innoVactiv Inc.

Registry information

Official study title

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

Acronym: Algues

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Mar 9, 2017
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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