跳至主要内容
临床试验/NCT05009615
NCT05009615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 Nutrición2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Body weight

研究概览

简要总结

The study aimed at assessing the effect of a decaffeinated green coffee extract, rich in hydroxycinnamates, oat beta-glucans or the combination of both bioactive compounds on overweight/obese subjects with hyperglycemia.

详细描述

In a randomized, crossover, blind, three-arm study, volunteers consumed twice a day a nutraceutical providing 5 g/d beta-glucan (BG), 600 mg/d green coffee polyphenols (GC) or a combination of both (5 g/d BG + 600 mg/d GC). Each intervention stage lasted 8 weeks and was followed by a 4-week wash-out.

Blood, urine and fecal samples were obtained at the beginning and end of each intervention stage. Blood pressure, oral glucose tolerance test (OGTT) and body composition (body weight, anthropometry, bioimpedance) were measured at each control visit. Physical activity was controlled by accelerometry (1 week during each intervention stage). Energy expenditure was measured by calorimetry. Food intake was monitored by 3-d food records. Satiety was determined by subjective (VAS) and objective (weighting consumed food) records after consuming the nutraceutical during each intervention stage.

In a subset of volunteers (9), a pharmacokinetic study was performed to assess bioavailability and metabolism of polyphenols at the beginning and end of each intervention (GC and GC+BG only). In these volunteers, blood was taken at different times during 24 h; urine samples were also collected at different intervals during 24 h, and feces were obtained at 0 and 24 h approximately after consuming the nutraceuticals containing GC. A targeted metabolomic analysis was carried out in these samples. In these volunteers, incretins and hormones were also determined in blood samples.

研究设计

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

盲法说明

Nutraceutical was provided in aluminum foil sachets marked A, B or C for blinding to participants. Aroma and flavor compounds were added to ensure similar organoleptic properties of the 3 nutraceuticals tested.

入排标准

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

入选标准

  • Men and women, with BMI between 25-35 kg/m2
  • Fasting blood glucose between 6,11-6,94 mmol/L (110-125 mg/dL) and/or
  • Blood glucose between 7,77-11,04 mmol/L (140-199 mg/dL) 2 h after an oral glucose overload

排除标准

  • Having other chronic pathologies different from overweight/obesity and prediabetes.
  • On prescription drugs, hormones or dietary supplements (e.g. dietary fibre, pollen, vitamin complexes, etc.)
  • Vegetarian
  • Known hypersensibility/allergy to any of the tests products
  • Pregnant women
  • On dietary regimen or physical training to lose weight

结局指标

主要结局

Body weight

时间窗: 8 weeks

Change of body weight (estimated 2.5 kg) at the end of the intervention

次要结局

  • Insulin resistance(8 weeks)
  • Body fat percentage(8 weeks)
  • Anthropometry(8 weeks)
  • Blood lipids(8 weeks)

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 (2)

Loading locations...

相似试验