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临床试验/NCT04945109
NCT04945109已完成不适用

The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A Randomized Crossover Controlled Trial

Ben-Gurion University of the Negev2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Changes in glycemic control

研究概览

简要总结

The investigators primarily aim to explore the effect of daily additive supplementation of Mankai on glucose control among participants with T2D.

详细描述

Type 2 diabetes is a major public health concern in Western societies. Type 2 diabetes is associated with high morbidity and shorter life expectancy. In patients with type 2 diabetes maintaining glycemic control is associated with lower rates of complications and mortality associated with the disease. Thus, there is a great need to recognize nutritional elements that improve glycemic control and insulin sensitivity in patients with type 2 diabetes. Mankai, a strain of Wolffia globosa recently developed under controlled conditions, is characterized by high protein content and good bioavailability of proteins, rich in soluble fiber, vitamins (including vitamin B12), minerals (including iron and zinc), omega 3 fatty acids, and polyphenols. The 18-month long DIRECT PLUS trial was a weight-loss intervention conducted among 294 participants with abdominal obesity or dyslipidemia. 98 of the study participants were assigned to the intervention of a green Mediterranean diet and were instructed to consume four frozen cubes of Mankai daily. Main conclusions from the DIRECT PLUS refer to the beneficial effect of the green-Mediterranean diet on cardiometabolic risk, gut bacteria, and liver fat, with no evidence of disadvantages or adverse effects of long-term Mankai consumption. In 2019, the investigators reported that among non-diabetics and those with fasting glucose levels within the normal range, consuming a Mankai smoothie in the evening led to lower glucose levels after the meal and lower fasting overnight compared to a yogurt smoothie. The investigators now plan to explore the effect of Mankai daily supplementation on post-meal glycemic response in participants with type 2 diabetes. The investigators hypothesize that the addition of Mankai consumption after a meal may mitigate glucose excursions compared with control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age => 30 years
  • A formal diagnosis of T2D (126mg/dl fasting glucose or higher, or HbA1c=>6.5%) or taking T2D medications.

排除标准

  • Treatment with coumadin (warfarin)
  • Advanced renal failure
  • A significant illness that might require hospitalization
  • State of pregnancy or lactation
  • Presence of active cancer or chemotherapy treatment in last three years
  • Participation in another trial.

结局指标

主要结局

Changes in glycemic control

时间窗: Through study completion, 24hours a day (continuous measurement, all day, 4 weeks)

Continuous glucose excursions monitoring

次要结局

  • Serum liver Enzymes(0, 2, 4 weeks)
  • Inflammation(0, 2, 4 weeks)
  • Blood pressure(0, 2, 4 weeks)
  • Urine markers of glucose(0,2,4 weeks)
  • Insulin(0, 2, 4 weeks)
  • Fasting glucose(0, 2, 4 weeks)
  • Serum lipids(0, 2, 4 weeks)
  • Microbiota profile(0, 2, 4 weeks)
  • CBC(0, 2, 4 weeks)
  • Abdominal obesity(0, 2, 4 weeks)
  • Anthropometric(0, 2, 4 weeks)
  • Pulse(0, 2, 4 weeks)
  • Urine markers of protein(0,2,4 weeks)
  • questionnaire 1(0, 2, 4 weeks)
  • questionnaire 2(0, 2, 4 weeks)
  • questionnaire 3(0, 2, 4 weeks)
  • questionnaire 4(0, 2, 4 weeks)

研究者

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

Iris Shai

Prof. Iris Shai

Ben-Gurion University of the Negev

研究点 (2)

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