STARchy Staples: a Randomised Controlled Trial on Cardiometabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in 7-day sleep efficiency
研究概览
简要总结
An investigation into habitual potato consumption (mashed, boiled, baked) on sleep quality and chronic glycaemic control, established risk factors for cardiometabolic diseases, versus habitual consumptions of non-nutrient-dense starchy staples (white rice, pasta, and couscous).
详细描述
In the last few years, researchers have undergone efforts to conduct well-controlled trials to investigate the cardiometabolic health effect of consuming potatoes as part of a healthy diet. None to our knowledge, however, have investigated the harmful dyad of poor sleep and adverse glycaemic control, 2 interrelated factors which can exacerbate cardiometabolic (CM) health outcomes. The nutrient density of potatoes, namely being the single richest source of potassium per serving, provides a plausible mechanism in which the potatoes may act to improve health markers.
The primary objective of this study is to investigate whether consuming a portion of nutrient-dense potatoes in the evening meal, in place of other refined carbohydrates, can improve sleep quality, and improve nocturnal, and 24-hour, glycaemic control, both risk factors for CM diseases. Secondly, this study aims to investigate the effects of potato consumption on endothelium-dependent vasodilation, which can further interrelate to this web of interactions, and other measures of CM health.
Study design: A randomised, two-parallel arm, in-clinic and remote, 12-week dietary intervention study.
Study population: Healthy male and female 40-80-year-olds, who consume ≤4 fruits and vegetables per day and have sub-optimal sleep quality.
The study aims to recruit a total of 80 participants, allowing for an estimated 15% dropout rate, to reach 80% power at a significance level of 0.025 (based on two outcomes). The allocation ratio is 1:1 intervention to control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will be blinded to whether they are receiving the intervention or control, but it is not possible to blind them to the food itself. The researcher conducting the statistical analysis will be blinded prior to analysis, using a second set of unique study ID codes.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-reported healthy adults
- •Aged 40-80 years old
- •Intake of ≤4 portions of fruits and vegetables (excluding potatoes) per day
- •Low sleep quality index of >5 (Pittsburgh sleep quality index).
排除标准
- •Shift workers and those with multiple jobs or carers who are required to wake through the night
- •Unwilling to refrain from dietary supplements
- •Unwilling to follow protocol and/or give informed consent
- •Diagnosed with Cardiovascular Disease (CVD), Type 2 Diabetes, Celiac disease, Insomnia, Sleep apnoea
- •Presence of gastrointestinal disorder
- •Users of drugs that are likely to alter gastrointestinal motility or nutrient absorption
- •History of substance abuse or alcoholism
- •Currently pregnant, planning pregnancy, breastfeeding, or having had a baby 12 months prior
- •Weight change of >3kg in the preceding 2 months
- •BMI <18.5kg/m2 or > 35kg/m2,
- •Current smokers, or individuals who quit smoking in the last 6-months
- •Frequently consume wholemeal products (1-2 times per day, in the short screening FFQ)
- •Never consumed refined starchy staples, such as white pasta or rice (rarely or never, in the short screening FFQ)
- •High potato consumption (4-6 times per week, in the short screening FFQ)
- •High risk of obstructive sleep apnoea (answer yes to >3 questions, in STOP-Bang questionnaire)
- •Vegetarian, Vegan, or pescatarian dietary preferences.
- •Diagnosed with mental health disorders, and/or on medicine for their mental health (antipsychotics, antidepressants, beta-blockers)
- •Chronic user of antihistamines
- •Fasting glucose >7mmol/l (finger prick test at baseline clinic)
- •Is taking weight loss, or glucose regulating medications.
- •Has been unstable on blood pressure lowering medications for at least 3-months prior to enrollment.
结局指标
主要结局
Change in 7-day sleep efficiency
时间窗: Pre- and post-intervention: 12 weeks
Differences in % sleep efficiency at endline vs baseline. Sleep efficiency % is described as the total time spent asleep/ total time spent in bed x 100.
Change in 12-day nocturnal mean glucose
时间窗: Pre- and post-intervention: 12 weeks
Differences in mean nocturnal glucose, measured using a Freestyle Libre 3 continuous glucose monitor.
次要结局
- Change in heart rate variability during mental stress(Pre- and post-intervention: 12 weeks)
- Change in 24-hour heart rate variability(Pre- and post-intervention: 12 weeks)
- Change in Endothelial function(Pre- and post-intervention: 12 weeks)
- Change in body fat %(Pre- and post-intervention: 12 weeks)
- Change in waist circumference (cm)(Pre- and post-intervention: 12 weeks)
- Change in BMI kg/m2(Pre- and post-intervention: 12 weeks)
- Change in plasma lipids(Pre- and post-intervention: 12 weeks)
- Change in fasting plasma glucose(Pre- and post-intervention: 12 weeks)
- Change in fasting insulin(Pre- and post-intervention: 12 weeks)
- Change in fasting HbA1C(Pre- and post-intervention: 12 weeks)
- Change in serum potassium(Pre- and post-intervention: 12 weeks)
- Change in sleep duration, in minutes(Pre- and post-intervention: 12 weeks)
- Change in sleep duration, in %(Pre- and post-intervention: 12 weeks)
- Change in mean nocturnal AUC(Pre- and post-intervention: 12 weeks)
- Difference in nocturnal TIR(Pre- and post-intervention: 12 weeks)
- Change in the nocturnal CV%(Pre- and post-intervention: 12 weeks)
- Change in nocturnal MAGE(Pre- and post-intervention: 12 weeks)
- Change in nocturnal MODD(Pre- and post-intervention: 12 weeks)
- Change in mean daytime glycaemic control(Pre- and post-intervention: 12 weeks)
- Difference in daytime TIR(Pre- and post-intervention: 12 weeks)
- Change in the daytime CV%(Pre- and post-intervention: 12 weeks)
- Change in daytime MAGE(Pre- and post-intervention: 12 weeks)
- Change in daytime MODD(Pre- and post-intervention: 12 weeks)
- Change in mean 24-hour glycaemic control(Pre- and post-intervention: 12 weeks)
- Difference in 24-hour TIR(Pre- and post-intervention: 12 weeks)
- Change in the 24-hour CV%(Pre- and post-intervention: 12 weeks)
- Change in 24-hour MAGE(Pre- and post-intervention: 12 weeks)
- Change in 24-hour MODD(Pre- and post-intervention: 12 weeks)
- Change in heart rate variability during mental stress(Pre- and post-intervention: 12 weeks)
- Change in 24-hour heart rate variability(Pre- and post-intervention: 12 weeks)
- Change in Endothelial function(Pre- and post-intervention: 12 weeks)
- Nocturnal continuous blood pressure(Whole 12 week period.)
- Daytime continuous blood pressure(Whole 12 week period.)
- Change in blood pressure(Pre- and post-intervention: 12 weeks)
- Change in sleep latency(Pre- and post-intervention: 12 weeks)
- Change in body fat %(Pre- and post-intervention: 12 weeks)
- Change in waist circumference (cm)(Pre- and post-intervention: 12 weeks)
- Change in BMI kg/m2(Pre- and post-intervention: 12 weeks)
- Calystegine potato biomarker(Pre- and post-intervention: 12 weeks)