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临床试验/NCT03853343
NCT03853343已完成不适用

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

BioAtlantis Ltd.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年6月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Change in Plasma Glucose concentration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Placebo

Placebo Comparator

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

干预措施: Placebo (Dietary Supplement)

Seaweed extract

Active Comparator

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

干预措施: Seaweed extract (Dietary Supplement)

结局指标

主要结局

Change in Plasma Glucose concentration

时间窗: 3 weeks

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

Change of Plasma Insulin concentration

时间窗: 3 weeks

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

Change in metabolic parameters

时间窗: 3 weeks

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

次要结局

  • Change in Blood Lipids(3 weeks)
  • Change in plasma Markers of inflammation(3 weeks)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Dr. George Tzortzis

Principle Investigator Human Health

BioAtlantis Ltd.

研究点 (1)

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