NCT03853343

Brief Summary

Double blinded, randomized, placebo controlled preliminary pilot exploratory investigation into the effects of brown seaweed extract supplementation, on fasting blood Insulin, fasting blood glucose, insulin sensitivity, blood inflammatory markers and tolerance in healthy overweight adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

March 2, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

January 22, 2019

Last Update Submit

March 1, 2022

Conditions

Metabolic SyndromeInsulin Sensitivity

Outcome Measures

Primary Outcomes (3)

  • Change in Plasma Glucose concentration

    Changes in plasma glucose in healthy volunteers with BMI\>25 after 3 weeks of treatment

    3 weeks

  • Change of Plasma Insulin concentration

    Changes in plasma insulin in healthy volunteers with BMI\>25 after 3 weeks of treatment

    3 weeks

  • Change in metabolic parameters

    Changes in insulin sensitivity based on Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) test

    3 weeks

Secondary Outcomes (2)

  • Change in Blood Lipids

    3 weeks

  • Change in plasma Markers of inflammation

    3 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

3 capsules per day (1 before each meal) of cellulose

Dietary Supplement: Placebo

Seaweed extract

ACTIVE COMPARATOR

3 capsules per day (1 before each meal) of seaweed extract

Dietary Supplement: Seaweed extract

Interventions

Seaweed extractDIETARY_SUPPLEMENT

1 capsule 3 times per day

Seaweed extract
PlaceboDIETARY_SUPPLEMENT

1 capsule 3 times per day

Placebo

Eligibility Criteria

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

You may qualify if:

  • Body Mass Index (BMI) 25-35 kg/m2
  • Not dieting within the last month and not having lost \>5% body weight in the previous year
  • Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study
  • Understands and is willing, able and likely to comply with all study procedures and restriction including being willing to follow the nutritional advice
  • Able to eat most everyday foods
  • Habitually consumes three standard meals a day

You may not qualify if:

  • Significant health problems (e.g. hypercholesterolaemia, diabetes, GI disorders)
  • Taking any medication or supplements known to affect mineral or glucose metabolism within the past month and/or during the study
  • Pregnant, planning to become pregnant or breastfeeding
  • History of anaphylaxis to food
  • Known allergies or intolerance to foods and/or to the study materials (or closely related compounds) or any of their stated ingredients
  • BMI \<25 kg/m2 or \>35 kg/m2
  • Volunteers self-reporting currently dieting or having lost \>5% body weight in the previous year
  • Participants with abnormal eating behaviour
  • Participation in another experimental study or receipt of an investigational drug/product within 30 days of the screening visit
  • Volunteers who have significantly changed their physical activity in the past 2-4 weeks or who intend to change them during the study
  • Participants receiving systemic or local treatment likely to interfere with the evaluation of the study parameters
  • Participants on specific food avoidance diets
  • Participants who work in appetite or feeding related areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roehampton University

London, SW15 5PJ, United Kingdom

Location

MeSH Terms

Conditions

Metabolic SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • George Tzortzis

    BioAtlantis Ltd.

    STUDY DIRECTOR

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
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator Human Health

Study Record Dates

First Submitted

January 22, 2019

First Posted

February 25, 2019

Study Start

June 28, 2018

Primary Completion

January 30, 2020

Study Completion

January 30, 2022

Last Updated

March 2, 2022

Record last verified: 2022-03

Locations

GB(1)