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Seaweed Extract Supplementation and Metabolic Biomarkers

Primary Purpose

Metabolic Syndrome, Insulin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Seaweed extract
Placebo
Sponsored by
BioAtlantis Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Roehampton University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Seaweed extract

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Plasma Glucose concentration
Changes in plasma glucose in healthy volunteers with BMI>25 after 3 weeks of treatment
Change of Plasma Insulin concentration
Changes in plasma insulin in healthy volunteers with BMI>25 after 3 weeks of treatment
Change in metabolic parameters
Changes in insulin sensitivity based on Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) test

Secondary Outcome Measures

Change in Blood Lipids
Changes in total cholesterol, HDL-C and triglycerides following 3 weeks supplementation
Change in plasma Markers of inflammation
Changes in Tumor Necrosis Factor-alpha, Interleukin-6, Interleukin-1b, Interleukin-10, Interferon-gamma and C-Reactive Protein following 3 weeks of supplementation

Full Information

First Posted
January 22, 2019
Last Updated
March 1, 2022
Sponsor
BioAtlantis Ltd.
Collaborators
University of Roehampton
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1. Study Identification

Unique Protocol Identification Number
NCT03853343
Brief Title
Seaweed Extract Supplementation and Metabolic Biomarkers
Official Title
Pilot Exploratory Investigation Into the Effects of Brown Seaweed Extract Supplementation on Metabolic Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
BioAtlantis Ltd.
Collaborators
University of Roehampton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Diabetes melitus is a group of metabolic disorders resulting from a defect in insulin production and/or insulin action. The World Health Organisation (WHO) has estimated that the total number of people with diabetes mellitus worldwide will increase from 171 million in 2000 to nearly 370 million in 2030 with the prevalence of the disease for all age groups to be 4.4%. 90% of diabetes cases worldwide are of Type II diabetes mellitus (T2DM) as a result of greater prevalence of sedentary lifestyle, unhealthy diet and rise of obesity, as well as an increasing number of elderly population. T2DM can be attributed to relative deficiency of insulin, involving insulin resistance, aberrant synthesis of hepatic glucose and progressive deterioration of pancreatic beta-cell functions resulting in chronic hyperglycaemia with disturbances in carbohydrate, fat and protein metabolism. Insulin resistance, classically defined as a decreased sensitivity to metabolic actions of insulin, is recognised as an important risk factor in the pathogenesis of various disorders, including T2DM. However, insulin resistance and ß-cell dysfunction can be asymptomatic and may remain undiagnosed for many years. Current T2DM management employs a range of pharmacological (hypoglycaemic agents) and lifestyle (diet, exercise) intervention approaches aiming at managing hyperglycaemia, with the main objective being to ensure sufficient delivery of glucose to the various tissues of the body and prevent hyperglycaemia by achieving good glycemic control. Nutrition has been regarded to play a significant role in the complex pathophysiology of T2DM and in the last several years, increasing amount of evidence has emerged linking various nutrients and food sources with a positive management of T2DM. Seaweed have traditionally been consumed as a readily available whole food or traditional medical preparations, especially in Asia. Seaweeds are rich in bioactive compounds in the form of polyphenols, carotenoids, vitamins, minerals, phycobilins, phycocyanins, and polysaccharides, many of which are known to offer a wide range of benefits in human health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Insulin Sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3 capsules per day (1 before each meal) of cellulose
Arm Title
Seaweed extract
Arm Type
Active Comparator
Arm Description
3 capsules per day (1 before each meal) of seaweed extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Seaweed extract
Intervention Description
1 capsule 3 times per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
1 capsule 3 times per day
Primary Outcome Measure Information:
Title
Change in Plasma Glucose concentration
Description
Changes in plasma glucose in healthy volunteers with BMI>25 after 3 weeks of treatment
Time Frame
3 weeks
Title
Change of Plasma Insulin concentration
Description
Changes in plasma insulin in healthy volunteers with BMI>25 after 3 weeks of treatment
Time Frame
3 weeks
Title
Change in metabolic parameters
Description
Changes in insulin sensitivity based on Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) test
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Change in Blood Lipids
Description
Changes in total cholesterol, HDL-C and triglycerides following 3 weeks supplementation
Time Frame
3 weeks
Title
Change in plasma Markers of inflammation
Description
Changes in Tumor Necrosis Factor-alpha, Interleukin-6, Interleukin-1b, Interleukin-10, Interferon-gamma and C-Reactive Protein following 3 weeks of supplementation
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Tzortzis
Organizational Affiliation
BioAtlantis Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Roehampton University
City
London
ZIP/Postal Code
SW15 5PJ
Country
United Kingdom

12. IPD Sharing Statement

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Seaweed Extract Supplementation and Metabolic Biomarkers

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