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临床试验/NCT05738655
NCT05738655招募中不适用

Effectiveness of Pumpkin Seed Extract on Improving Blood Sugar Level in Subhealth Subjects

Greenyn Biotechnology Co., Ltd.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Biochemical analysis

研究概览

简要总结

This randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract on blood sugar management in subhealth people.

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fasting blood sugar levels from 100 to 125 mg/dL
  • Glycated hemoglobin levels from 5.7 to 6.4%
  • 2-hour OGTT levels from 140 to 199 mg/dL

排除标准

  • Pregnant women or preparing for pregnancy.
  • Lactating women.
  • Women gave birth 6 months before the study.
  • Poor kindy funciton
  • Severe cardiovascular or other chronic diseases
  • Patients with type I or II diabetes
  • Poor compliance
  • Alcohol abuser
  • Using anti-diabetic or weight managent supplements
  • Blood transfusion three months before the study
  • Pumpkin seed allergy

研究组 & 干预措施

Placebo group

Placebo Comparator

Placebo capsule, one capsule/day (300 mg/day) for 3 months

干预措施: Placebo (Dietary Supplement)

Low dose

Experimental

Pumpkin seed extract capsule, one capsule/day (300 mg/day) for 3 months

干预措施: Pumpkin seed extract (Low dose) (Dietary Supplement)

High dose

Experimental

Pumpkin seed extract capsule, two capsules/day (600 mg/day) for 3 months

干预措施: Pumpkin seed extract (High dose) (Dietary Supplement)

结局指标

主要结局

Biochemical analysis

时间窗: Baseline up to 12 weeks

Changes in fasting blodd sugar levels of 60 pariticpants will be analyzed between baseline and week 12.

Hormone analysis

时间窗: Baseline up to 12 weeks

Changes in GLP-1 levels of 60 pariticpants will be analyzed between baseline and week 12.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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