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临床试验/NCT03374501
NCT03374501已完成不适用

Determination of the Glycemic and Insulinemic Index Values of Soft Drink and Two Test Meals Containing Soft Drink Consumed With Sugardown™

Boston Therapeutics0 个研究点目标入组 10 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
主要终点
Glycemic index of the three test meals.

研究概览

简要总结

This study was a partly controlled laboratory-based study comparing the glycemic and insulinemic indices of 3 test meals containing soft drink alone or with SUGARDOWN™ (Galactomannan) in overweight adults.

详细描述

STUDY SUMMARY This study was a partly controlled, laboratory-based study comparing the short-term postprandial glucose and insulin responses produced by three test meals containing soft drink consumed alone or with SUGARDOWN™, relative to the responses produced by an equal-carbohydrate portion of glucose solution (the reference food). The study used a repeated measures design, such that every subject consumed the reference food and each test food on two separate occasions, completing a total of eight separate test sessions. Each subject completed their test sessions on separate weekday mornings at a similar time each day, as close as possible to the time they would normally eat breakfast.

SUBJECTS Ten healthy, non-smoking, overweight or obese subjects (6 females and 4 males) voluntarily participated in this study. The mean ± SD age of the subjects was 32.4 ± 10.9 yr (range: 18.7 - 55.6 yr), and their mean ± body mass index value was 27.4 ± 2.6 kg/m2 (range: 25.3 - 32.3 kg/m2).

Volunteers were given detailed written and verbal information about all of the study's inclusion criteria and experimental procedures. If the volunteers decided that they would like to participate in the study, they were asked to come to the research centre on another morning, where they completed a detailed screening questionnaire that assessed their current health status and medical history. In order to participate in the study, the volunteers had to meet the inclusion criteria. All suitable volunteers that were invited to participate in the study were required to sign a detailed subject information sheet and a consent form before commencing any experimental procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Aged between 18-65 years.
  • Non-smoker.
  • Stable body weight within the overweight weight range for their height (BMI values 25 kg/m2 for Causcasian individuals and >23 kg/m2 for Asian individuals).
  • Normal dietary habits; not dieting or eating in an overly restrictive fashion in the past 3 months.
  • A regular pattern of low to moderate physical activity.
  • Able to fast for ≥ 10 hours the night before each test session.
  • Able to refrain from eating a legume-based evening meal or drinking alcohol the day before each test session.
  • Finds the test foods suitable for consumption within 12 minutes.
  • Not taking any treatment for anorexia, weight loss, or any form of treatment or medication likely to interfere with metabolism or dietary habits.
  • Signed the informed consent form for the study.

排除标准

  • Currently following a restrictive diet (low-calorie, low-carbohydrate, vegan).
  • Any clinically significant physical or mental illness.
  • Suffering from a food allergy or serious food intolerance.
  • Regularly taking prescription medication other than standard contraceptive medication.
  • Females who are currently pregnant, breast-feeding, trying to become pregnant or not using an acceptable contraceptive.
  • Participating in another clinical trial or participated in another clinical trial within the two weeks.
  • Undergoing general anaesthesia in the month prior to inclusion.
  • Subject in a situation, which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.

研究组 & 干预措施

Soft drink

Placebo Comparator

Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink

干预措施: Soft drink (Dietary Supplement)

2 tablets Sugardown™

Experimental

Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 2 tablets of Sugardown™

干预措施: Sugardown™ (Dietary Supplement)

4 tablets Sugardown™

Experimental

Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 4 tablets of Sugardown™

干预措施: Sugardown™ (Dietary Supplement)

结局指标

主要结局

Glycemic index of the three test meals.

时间窗: 2 days

Blood samples were collected into a micro-centrifuge tube containing the anticoagulant, heparin sodium salt. Plasma glucose concentrations were measured in duplicate using a spectrophotometric centrifugal analyser employing the glucose hexokinase/glucose-6-phosphate dehydrogenase enzymatic assay.

次要结局

  • Insulinemic index of the three test meals.(2 days)

研究者

发起方
Boston Therapeutics
申办方类型
Industry
责任方
Sponsor

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