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临床试验/NCT05977543
NCT05977543进行中(未招募)不适用

The Acute Effect of Functional Crackers, Enriched With Grape Seed Flour or With Barley Flour and β-glucans, on Postprandial Glycemic, Lipemic and Antioxidant Metabolism

University of the Aegean1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2023年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
13
试验地点
1
主要终点
Total Antioxidant Capacity

研究概览

简要总结

The aim of this interventional study was to investigate the postprandial effect of two types of functional crackers, with 10% grape seed flour or 40% barley flour, enriched with β-glucan, in metabolic biomarkers of healthy participants.

详细描述

A pilot cross-over, controlled, randomized and single-blinded, intervention-clinical trial was carried out, in twelve healthy men and women, aged nineteen to sixty-five years, after random allocation into the control, the grape and the barley interventional groups, received a high-fat and high-carbohydrate meal, containing wheat flour or wheat and 10% grape seed flour or wheat and 40% barley flour, enriched with β-glucan, crackers. Participants consumed the same meals, allocating in cross-over order, with 1 washout week after each trial period. Differences on the metabolism of postprandial serum total, High Density Lipoprotein (HDL-), Low Density Lipoprotein (LDL-) cholesterol, glucose, triglycerides and uric acid levels, as well as of plasma total antioxidant capacity according to Ferric Reducing Antioxidant Power method, were determined between groups in fasting, thirty minutes, one and a half hour, and three hours after meal intake.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

盲法说明

Only investigators knew the group in which each participant were enrolled.

入排标准

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

入选标准

  • •Age 19-65 years

排除标准

  • •Age over 65 years old
  • •History of chronic illness including type I and II diabetes (hemoglobin A1c-HbA1c > 5%)
  • •Abnormal Body Mass Index (BMI) (>25 kg/m2)
  • •Alcohol overconsumption (>40 g alcohol/day)
  • •Abnormal hematological and biochemical profiles (cholesterol > 6.8 mM, triglycerides > 2.8 mM, glucose > 6.11 mM)

研究组 & 干预措施

Control wheat crackers

No Intervention

Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers.

Grape seed flour crackers

Other

Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers, enriched with 10% grape seed flour crackers.

干预措施: Functional crackers enriched with grape seed flour (Other)

Barley flour and β-glucan crackers

Other

Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of 60% wheat flour and 40% barley flour crackers, enriched with β-glucan

干预措施: Functional crackers with 40% barley flour and enriched with β-glucans (Other)

结局指标

主要结局

Total Antioxidant Capacity

时间窗: 3 hours

Total Antioxidant Capacity concentration changes from baseline at 3 hours

Glucose

时间窗: 3 hours

Glucose concentration changes from baseline at 3hours

次要结局

  • High Density Lipoprotein cholesterol(3 hours)
  • Low Density Lipoprotein cholesterol(3 hours)
  • Total cholesterol(3 hours)
  • Triglycerides(3 hours)
  • Uric Acid(3 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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