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临床试验/NCT06515340
NCT06515340已完成不适用

Effect of Allulose on Diet-induced Thermogenesis, Substrate Oxidation, Glycemic Response, and Satiety in Normal Weight Adults

Toronto Metropolitan University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2024年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Diet-induced thermogenesis

研究概览

简要总结

The objective of this study is to investigate the dose-response effect of allulose on diet-induced thermogenesis, substrate oxidation, glycemic response, and subjective appetite in healthy normal weight adults.

详细描述

A within-subject, repeated measures, randomized, repeated measures design will be used. Participants (n= 10, 5 males, 5 females) will consume, in a random order, one of three varying doses of test treatments (allulose (5g), allulose (10g) or allulose (20g)) on 3 separate days. After treatment consumption, energy expenditure measurements via indirect calorimetry will be collected in 30-min interval (30-min measurement, 30-min rest) for 3 hours. Blood glucose will be measured at baseline and continuously for 3 hours via the Dexcom G6 continuous glucose monitoring system. Subjective appetite (hunger, fullness, desire to eat, prospective food consumption) will be measured via visual analogue scales at baseline and at the end of each energy expenditure measurement interval over 3 hours.

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 (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants (18 - 45 years) who are considered healthy, are non-smokers, and have a body mass index (BMI) between 20 and 24.9 kg/m2 [World Health Organization classification of normal weight BMI].

排除标准

  • Participants who have a fasting plasma glucose > 5.5 mmol/L indicative of impaired fasting glucose, previously diagnosed diabetes, known or uncertain pregnancy status at the screening visit, gastrointestinal disease, liver or kidney disease, have undergone a major medical or surgical event within the past 6 months, were or are on a diet, skip breakfast, smoke or have taken medication which would be a potential confounder with effects on metabolic and intake regulation.
  • Those unable to complete the testing protocols or are intolerant or allergic to test-day ingredients.

结局指标

主要结局

Diet-induced thermogenesis

时间窗: Collected at baseline (before treatment consumption) and 30-min intervals for 3 hours post-treatment consumption.

Before treatment consumption, participants will be rested in a supine position for 30 min to reach a steady resting state in an isolated, dimly lit room under controlled temperature and humidity conditions. Resting energy expenditure (REE) will be determined by indirect calorimetry (ParvoMedics TrueOne2400 automated metabolic gas analysis system, ParvoMedics, Sandy, UT, USA) under a ventilated hood for 30 min. Post-treatment consumption, respiratory gases will be measured in 30 min intervals for 3 hours under the ventilated hood using the indirect calorimeter, with a 30 min rest break between measurements. Diet-induced thermogenesis (kcal/h) will be calculated as the increase in energy expenditure above baseline REE over the duration of the measurements.

次要结局

  • Substrate oxidation(Collected at baseline (before treatment consumption) and 30-min intervals for 3 hours post-treatment consumption.)
  • Glycemic response(Collected at baseline (before treatment consumption) and 5-min intervals for 3 hours post-treatment consumption.)
  • Subjective appetite(Collected at baseline (before treatment consumption) and 30 min intervals for 3 hours post-treatment consumption.)

研究者

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

Nick Bellissimo, PhD

Associate Professor

Toronto Metropolitan University

研究点 (2)

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