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临床试验/NCT04458493
NCT04458493Unknown不适用

Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?

Western University, Canada0 个研究点目标入组 50 人开始时间: 2020年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
changes in body weight

研究概览

简要总结

Participants will be randomized into two groups, one group will be the control (no intervention at all) and the other will be CHO-PRO (meal replacement, Generation UCAN supplement, 400ml, 20% solution). Prior to the start of the experiment, all participants will be asked to record their satiety ratings, appetite and desire to eat (10-point visual analogue scale) 30, 60 and 120 minutes after their regular dinner for 3 days. On the first day of the experiment, all participants will be asked to measure their waist and hip circumferences, fasting blood glucose level, maximal number of pushups and body weight using a scale at home prior to breakfast. Instructions on how to do the measurements properly will be recorded in a video and distributed to the participants. Participants in the control group will not receive any intervention. Participants in the CHO-PRO group will be provided with the supplement and they will be asked to consume the CHO - protein supplement (Generation UCAN supplement, 250ml, 10% solution) 6 to 7 hours after lunch, in place of their dinner for 6 weeks. They will also be asked to record their satiety ratings, appetite and desire to eat (10-point visual analogue scale) 30, 60 and 120 minutes after each meal replacement drink. All participants will be required to complete a dietary record, prior to, and during (at weeks 2 and 4) intervention. To track adherence of the CHO-PRO group, participants will be asked to check off the calendar that they did not consume the meal replacement due to various reasons. On day 43, all participants will be asked measure again waist and hip circumferences, fasting blood glucose level, maximal number of pushups and body weight using a scale at home prior to breakfast again.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •sedentary (<2 moderate exercise bouts/wk)
  • •between the ages of 18 to 40y
  • •body mass index (BMI) between >25

排除标准

  • •do not eat three meals a day typically
  • •taking medication that affects their eating patterns
  • •have metabolic and gastrointestinal diseases

研究组 & 干预措施

control

Experimental

no supplement will be provided on the day of the experiment

干预措施: satiety (Behavioral)

Generation UCAN

Experimental

carbohydrates - protein (Generation UCAN supplement, 400ml, 20% solution)

干预措施: satiety (Behavioral)

Generation UCAN

Experimental

carbohydrates - protein (Generation UCAN supplement, 400ml, 20% solution)

干预措施: Dietary Supplement: Generation UCAN supplementation (Dietary Supplement)

结局指标

主要结局

changes in body weight

时间窗: 1 day prior to the start of the experiment and on the 31st day of the experiment

body weight will be measured using a scale at home prior to breakfast

次要结局

  • changes in fasted blood glucose(1 day prior to the start of the experiment and on the 31st day of the experiment)
  • changes in waist and hip circumferences(1 day prior to the start of the experiment and on the 31st day of the experiment)
  • changes in desire to eat ratings(30, 60 and 120 minutes after each meal replacement drink)
  • changes in appetite ratings(30, 60 and 120 minutes after each meal replacement drink)

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Lemon

Principal Investigator

Western University, Canada

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