Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Resting metabolic rate
研究概览
简要总结
Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. Anthocyanins, found in high quantities in both tart cherries and blueberries are powerful antioxidants, that are potentially capable of improving cardiometabolic dysfunction. However, to date, no research has explored the cardiometabolic responses to tart cherry and blueberry supplementation.
Therefore, the primary purpose of the proposed investigation is to test the ability of oral tart cherry and blueberry supplementation to improve cardiometabolic parameters in healthy individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- 是
入选标准
- •18 years of age and above
- •Non-smoker
- •BMI < 30
- •Able to give informed consent
排除标准
- •Pregnancy
- •Diabetes or any other metabolic/ uncontrolled hypertensive conditions
- •Food allergies to cherries or blueberries
- •Habitual consumption of blueberries/ cherries and/or blueberry/ cherry products
- •Not regularly taking medication or antioxidant supplements
结局指标
主要结局
Resting metabolic rate
时间窗: 20 days
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of carbohydrates
时间窗: 20 days
% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Blood glucose
时间窗: 20 days
Capillary blood glucose - mmol/L
Resting utilization of fats
时间窗: 20 days
% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Coop-Wonka chart
时间窗: 20 days
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.
Blood pressure
时间窗: Baseline
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Waist to hip ratio
时间窗: 20 days
Ratio of waist to hip circumference - measured using anthropocentric tape
Low-moderate intensity activity utilization of carbohydrates
时间窗: 20 days
% contribution of carbohydrates to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
State Trait Anxiety Inventory
时间窗: 20 days
Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
Insomnia Severity Index
时间窗: 20 days
Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Pittsburgh Sleep Quality Index
时间窗: 20 days
Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.
Beck Depression Inventory
时间窗: 20 days
Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
% bodyfat
时间窗: 20 days
Participants percentage composition of fat - measured using bio-electrical impedance
Low-moderate intensity activity calories expended
时间窗: 20 days
Estimated calorie usage (Kcal) during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Low-moderate intensity activity utilization of fats
时间窗: 20 days
% contribution of fats to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Blood cholesterol (Total, HDL & LDL)
时间窗: 20 days
Capillary blood cholesterol - mmol/L
Blood triglycerides
时间窗: 20 days
Capillary blood triglycerides - mmol/L
Blood haemoglobin
时间窗: 20 days
Capillary blood haemoglobin - g/L
Epworth Sleepiness Scale
时间窗: 20 days
Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
次要结局
未报告次要终点
研究者
Jonathan Sinclair
Principal Investigator - Professor of Sport, Exercise & Nutritional Sciences
University of Central Lancashire