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临床试验/NCT02412995
NCT02412995已完成早期 1 期

The Effects of Sea Buckthorn and Strawberry on Postprandial Glycaemia, Insulinemia and Appetite - A Randomised, Controlled, Crossover Study of Danish Berries in Overweight and Obese Male Subjects

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
18
试验地点
2
主要终点
Glycemia Area under the plasma glucose concentration curve, concentration curve.

研究概览

简要总结

The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia as well as on metabolic profiles were examined in overweight or obese male subjects. The study was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test meals contained either sea buckthorn, strawberry or no berries and added sucrose to match with respect to sucrose content. Blood samples were collected at baseline and several times postprandially. Subjective appetite sensations were recorded at baseline and every 15-20 min until 140 min and a subsequent ad libitum intake was recorded. Urine samples were also collected at baseline and at several time intervals until 24 hours. Blood and urine were subjected to metabolic profiling to investigate potential biomarkers of berry intake.

详细描述

Purpose: Berries and mixed berry products exert acute effects on postprandial glycaemia and insulinemia, but very few berries have been studied, and primarily in normal weight subjects. Sea buckthorn and strawberry are compositionally widely different berries and may likely produce different responses. The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia were examined in overweight or obese male subjects. Subjective appetite sensations and ad libitum intake were also examined. Berries may thus improve health in longer studies; however, accurate assessment of berry intake is still problematic. The discovery of objective biomarkers for intake of berries is therefore important in assessing both intake and compliance. The investigators aimed to identify urinary exposure markers of two very different berries, strawberry and sea buckthorn, in humans.

Methods: The study was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test meals contained either sea buckthorn, strawberry or no berries and added sucrose to match with respect to sucrose content. Blood samples were collected at t = 0, 30, 45, 60, 90 and 120 min. Subjective appetite sensations were recorded at t = 0, 15, 30, 45, 60, 90, 120 and 140 min and subsequent ad libitum intake was recorded. Statistical differences in all continuous measures were evaluated based on the existence of a meal or a time-meal interaction by repeated measurements analyses or differences in the area under the curve (AUC) for that measure in a linear mixed model. Urine samples were collected on each test day at t=-15min, t=0-1h, t=1-2h, and t=2-24h and were analyzed by untargeted metabolomics. Multivariate analysis was applied to discover markers, followed by molecular fragmentation to ease their chemical identification.

研究设计

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

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy, male, aged 20-50 years and body mass index (BMI) 25-35 kg/m2

排除标准

  • Any current or chronic clinical conditions
  • Chronic/frequent use of medication
  • Blood donation
  • High level of strenuous physical activity (>10h/week)
  • High habitual alcohol consumption (>14 drinks/week)
  • Present or previous drug abuse
  • Participation in other human intervention studies, and obesity surgery

结局指标

主要结局

Glycemia Area under the plasma glucose concentration curve, concentration curve.

时间窗: postprandially 0-120min

Area under the plasma glucose concentration curve, concentration curve.

次要结局

  • Glycemic profile (calculated as the time in minutes during which the blood glucose concentration is above baseline concentration divided by the incremental peak value of blood glucose)(0-120 min)
  • Incremental insulin response Incremental area under the plasma insulin concentration curve.(Postprandially 0-30 and 0-60 min)
  • Meal perception VAS questionnaire(postprandially at 30min and 140 min)
  • urine metabolic profile(0-24 hrs)
  • plasma metabolic profile (metabolic profiling by UPLC-QTOF)(0-120min)
  • Insulin response Area under the plasma insulin concentration curve(postprandially 0-120min)
  • Appetite scores (visual analogue scale)(postprandially 0-140min)
  • Incremental area under the plasma glucose concentration curve(postprandially, 0-30 and 0-60min)

研究者

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

Professor Lars Ove Dragsted

Professor

University of Copenhagen

研究点 (2)

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