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临床试验/NCT04321590
NCT04321590已完成不适用

Efficacy of New Products Combining Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity and Associated Dysfunctions (Hyperglycemia and Dyslipemia)

Instituto de Ciencia y Tecnología de Alimentos y Nutrición1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月11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
发起方
入组人数
60
试验地点
1
主要终点
Anthropometric changes

研究概览

简要总结

Randomized, double blind, parallel study to assess the effect of a dietary supplement combining polyphenols (hydroxycinnamates from green coffee) and a soluble dietary fiber (oat beta-glucans) in obese/overweight subjects.

详细描述

This pilot study intends to select the best combination of beta-glucan and a green coffee bean phenolic extract. Four different supplements were formulated, containing 3 or 5 g of two types of beta-glucan, with 35% and 70% b-glucan content, together with 600 mg of the green coffee bean extract. Blind sachets were prepared containing half the daily dose of the supplement.

60 overweight/obese male and female volunteers (BMI 25-35 kg/m2, 18-60 y old) were recruited and randomly assigned to one of the four intervention groups. Volunteers were instructed to consume one sachet half an hour before lunch and dinner dissolved in 250 mL water daily during 6 weeks.

At the beginning and at the end of the study, volunteers came to the Human Nutrition Unit at the research center after an overnight fast. Urine and blood samples were obtained, blood pressure was measured and anthropometric measurements were performed. Dietary and physical activity records were collected.

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)

盲法说明

Blind sachets

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Overweight/obese subjects (BMI 25-35 kg/m2)

排除标准

  • •Pregnant women
  • •Medication/consumption of vitamins, dietary supplements, etc.

研究组 & 干预措施

3 g 35% beta-glucan

Experimental

Supplement containing 3 g of 35% oat beta-glucan

干预措施: Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg) (Dietary Supplement)

5 g 35% beta-glucan

Experimental

Supplement containing 5 g of 35% oat beta-glucan

干预措施: Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg) (Dietary Supplement)

3 g 70% beta-glucan

Experimental

Supplement containing 3 g of 70% oat beta-glucan

干预措施: Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg) (Dietary Supplement)

5 g 70% beta-glucan

Experimental

Supplement containing 5 g of 70% oat beta-glucan

干预措施: Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg) (Dietary Supplement)

结局指标

主要结局

Anthropometric changes

时间窗: End of 6-week intervention

Modification in body weight/percentage body fat

次要结局

  • Modification in blood lipids(End of 6-week intervention)

研究者

发起方
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Laura Bravo

Professor

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

研究点 (1)

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