Examining the Efficacy of a Commercially Available Multi-ingredient Liquid Tonic Drink on Postprandial Glycemia in Men and Women With Overweight and/or Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 3-hour postprandial glucose incremental area under the curve
研究概览
简要总结
A randomised, double blinded, placebo-controlled crossover design clinical trial conducted at the Mary MacKillop Institute for Health Research (MMIHR, Australian Catholic University) for individuals with overweight/ obesity. This study will measure the postprandial glucose and hormone responses to a high-carbohydrate meal with/ without a liquid tonic drink.
详细描述
Twenty individuals living with overweight/ obesity will be invited to attend the university laboratories on 2 separate occasions to participate in a postprandial (meal) challenge. Participants will consume the same high-carbohydrate meal on each visit, with or without a liquid tonic drink. This will be a cross-over design study, where participants will consume a placebo drink on the alternate visit. Participants will remain in the laboratory for 3-hours following the meal with a venous cannula in place, and have blood samples taken at regular timepoints. Blood samples will be analysed for glucose and appetite hormones. Participants will also wear a continuous glucose monitor throughout the period which encapsulates both study trials.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All researchers involved in undertaking the study and analysing the data will be blinded. Participants will be blinded. The dietitian preparing and serving the meal and drink will be unblinded.
入排标准
- 年龄范围
- 30 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥30-64 years
- •Body Mass Index (BMI) of ≥27.0 kg/m2
排除标准
- •younger than 30 or 65 years or older,
- •a BMI less than 27.0 kg/m2,
- •have an allergy to any of the components in the plant-based tonic (see section 6),
- •pregnant or breastfeeding,
- •regularly skipping breakfast (i.e. not consuming breakfast on 5/7 days per week),
- •any diagnosed metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism), gastrointestinal (e.g. Crohn's) or cardiovascular (e.g. heart failure) abnormalities,
- •on an energy-restricted diet; significant weight fluctuation in the previous 3 months (>5% body weight),
- •high alcohol consumption (>14 units/week) (as per Alcohol Drink Guidelines),
- •medication that is used to treat blood glucose,
- •unable to attend in person testing sessions, or
- •unable or unwilling to provide blood samples.
研究组 & 干预措施
Placebo drink
This arm will receive the placebo drink on their first postprandial challenge
干预措施: Breakfast meal challenge with placebo drink (Other)
Tonic drink
This arm will receive the tonic drink on their first postprandial challenge
干预措施: Breakfast meal challenge with tonic drink (Other)
结局指标
主要结局
3-hour postprandial glucose incremental area under the curve
时间窗: 3 hours
Venous glucose concentrations measured over the 3 hour period following consumption of the breakfast meal and tonic drink/ placebo, and calculated using the trapezoid method, with T0 concentration as baseline
次要结局
- Venous blood C-peptide responses(3 hours)
- Matsuda index (Marker of whole-body postprandial insulin sensitivity)(3 hours)
- 3-hour postprandial insulin incremental area under the curve(3-hours)
- 3-hour interstitial postprandial glucose incremental area under the curve(3 hours)
- Venous blood insulin to glucagon ratio's at baseline (T0) and 30 minutes (T30)(30 minutes)