Brown Seaweed Extract on Glycemic Control and Body Weight

Insulin Resistance Clinical Trial

— Algues  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075943
• Other study ID #: ALGUES 2016-227
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2022
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 31, 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Insulin Resistance
• PreDiabetes

Intervention

Dietary Supplement:
• InSea2
Daily supplement: 2 capsules of InSea2
• Placebo
Daily supplement: 2 capsules of Placebo

Locations

Country	Name	City	State
Canada	Institute of Nutrition and Functional Foods (INAF), Laval University	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	innoVactiv Inc., Ministry of Agriculture, Fisheries and Food, Quebec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Changes in blood pressure	Systolic and diastolic blood pressure (mmHg)	at baseline and at the end of the intervention (12 week)
Secondary	Changes in heart rate	Heart rate (n/min)	at baseline and at the end of the intervention (12 week)
Secondary	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)
Secondary	Changes in hsCRP	HsCRP (mg/L)	at baseline and at the end of the intervention (12 week)
Secondary	Changes in Il-6	IL-6 (pg/L)	at baseline and at the end of the intervention (12 week)
Secondary	Changes in marker of oxidative stress	F2-isoprostane (ng/mL)	at baseline and at the end of the intervention (12 week)
Secondary	Changes in markers of gut barrier integrity	LBP (ng/mL), zonulin (ng/mL)	at baseline and at the end of the intervention (12 week)