Seaweed Extract Supplementation and Metabolic Biomarkers

Metabolic Syndrome Clinical Trial

Official title:

Pilot Exploratory Investigation Into the Effects of Brown Seaweed Extract Supplementation on Metabolic Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853343
• Other study ID #: BioAtlDG001
• Status: Completed
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: January 30, 2022

Study information

• Verified date: March 2022
• Source: BioAtlantis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity
• Metabolic Syndrome

Intervention

Dietary Supplement:
• Seaweed extract
1 capsule 3 times per day
• Placebo
1 capsule 3 times per day

Locations

Country	Name	City	State
United Kingdom	Roehampton University	London

Sponsors (2)

Lead Sponsor	Collaborator
BioAtlantis Ltd.	University of Roehampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Plasma Glucose concentration	Changes in plasma glucose in healthy volunteers with BMI>25 after 3 weeks of treatment	3 weeks
Primary	Change of Plasma Insulin concentration	Changes in plasma insulin in healthy volunteers with BMI>25 after 3 weeks of treatment	3 weeks
Primary	Change in metabolic parameters	Changes in insulin sensitivity based on Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) test	3 weeks
Secondary	Change in Blood Lipids	Changes in total cholesterol, HDL-C and triglycerides following 3 weeks supplementation	3 weeks
Secondary	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	3 weeks