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| Name | Class |
|---|---|
| University of Roehampton | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 3 capsules per day (1 before each meal) of cellulose |
|
| Seaweed extract | Active Comparator | 3 capsules per day (1 before each meal) of seaweed extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seaweed extract | Dietary Supplement | 1 capsule 3 times per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Lipids | Changes in total cholesterol, HDL-C and triglycerides following 3 weeks supplementation | 3 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Tzortzis | BioAtlantis Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roehampton University | London | SW15 5PJ | United Kingdom |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo |
| Dietary Supplement |
1 capsule 3 times per day |
|
| 3 weeks |