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临床试验/NCT03734835
NCT03734835Unknown不适用

The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome and Its Components: A Randomized, Controlled Study

National Nutrition and Food Technology Institute2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Metabolic syndrome: Number of participants with treated metabolic syndrome

研究概览

简要总结

To study the effects of Hesperidin, flaxseed and both together in patients with metabolic syndrome, 100 patients will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, metabolic factors will be assessed and compared between groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age of 18 to 70 years
  • having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HD

排除标准

  • pregnancy or lactation
  • history of Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis
  • Following a program to lose weight in recent 3 mo

研究组 & 干预措施

hesperidin and flaxseed

Active Comparator

1000 mg hesperidin as two capsules and 30 grams flaxseed

干预措施: hesperidin and flaxseed (Dietary Supplement)

control

Placebo Comparator

no supplementation

干预措施: control (Other)

flaxseed

Active Comparator

30 grams flaxseed

干预措施: flaxseed (Dietary Supplement)

hesperidin

Active Comparator

1000 mg hesperidin as two capsules

干预措施: hesperidin (Dietary Supplement)

结局指标

主要结局

Metabolic syndrome: Number of participants with treated metabolic syndrome

时间窗: 12 weeks

Number of participants with treated metabolic syndrome

次要结局

未报告次要终点

研究者

发起方
National Nutrition and Food Technology Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Azita Hekmatdoost

Principal Investigator

National Nutrition and Food Technology Institute

研究点 (2)

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