NCT03075943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

March 6, 2017

Last Update Submit

August 12, 2022

Conditions

PreDiabetesInsulin Resistance

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • Changes in blood pressure

    at baseline and at the end of the intervention (12 week)

  • Changes in heart rate

    at baseline and at the end of the intervention (12 week)

  • Changes in lipid profile

    at baseline and at the end of the intervention (12 week)

  • Changes in hsCRP

    at baseline and at the end of the intervention (12 week)

  • Changes in Il-6

    at baseline and at the end of the intervention (12 week)

  • +2 more secondary outcomes

Study Arms (2)

InSea2

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

InSea2DIETARY_SUPPLEMENT

Daily supplement: 2 capsules of InSea2

Also known as: Brown seaweed extract supplement
InSea2
PlaceboDIETARY_SUPPLEMENT

Daily supplement: 2 capsules of Placebo

Also known as: Control
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Québec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Prediabetic StateInsulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Hélène Jacques, PhD

    Institue of Nutrition and Functional Food (INAF), Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 9, 2017

Study Start

December 1, 2016

Primary Completion

July 1, 2018

Study Completion

December 31, 2019

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations

CA(1)