Effects of Pomegranate Extract on Inflammatory Markers, Physical and Cognitive Function and Cardiometabolic Risk Factors in Older Adults: a Randomised Parallel Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Interleukin-6 (IL-6) levels
研究概览
简要总结
The growing ageing population has resulted in an increase in the prevalence of frailty, cognitive disorders and cardiovascular diseases, representing a major cause of disability in older adults. Inflammation has been suggested as a pivotal factor leading to these disorders and is exacerbated by obesity. Polyphenols are antioxidants and anti-inflammatory agents that have been previously linked to a decrease in inflammation and cardiometabolic risk factors and an improvement in physical and cognitive function, yet research remain limited and inconclusive. This study aims to assess the effect of daily pomegranate extract supplementation on inflammatory response, cognitive and physical function and cardiometabolic risk factors in older adults. Seventy-one normal weight and overweight participants (55-70 years) will be assigned to consume either pomegranate extract capsules or placebo capsules for 12 weeks. Anthropometric measures (weight, height, waist circumference and hip circumference), body composition, blood pressure and a fasted venous blood sample will be collected during each visit at baseline, week 6 & week 12. Participants will also undergo computerised cognitive tests and physical function tests. Inflammatory markers, telomerase activity, serum glucose and lipid levels will be analysed. Diet diaries will be collected 3 times (at baseline, week 6 & week 12) during the intervention. This study will help elucidate the effects of pomegranate supplementation and inform future longitudinal trials looking at the combination of antioxidants and other lifestyle factors (such as physical activity) on the promotion of well-being and healthy ageing.
详细描述
After signing an informed consent, participants will be asked to attend the Physiology Lab at Manchester Metropolitan University at baseline, week 6 and week 12. Anthropometric measures (weight, height, waist circumference and hip circumference) will be collected during each visit, and body composition will be measured using air displacement plethysmography (BOD POD®). Blood pressure will be measured 3 times after a 10-minute rest based on the World Health Organisation (WHO) protocol and a fasted venous blood sample (20 ml) will be collected. Participants will then undergo physical assessment tests (to assess standing balance, gait speed, and chair sit to stand) and computerised cognitive tests (to assess executive function, memory, vigilance and attention).
Participants will also answer a general demographic and lifestyle questionnaire during the first visit. To control for changes in the diet, they will be asked to fill a paper-based 3-day food diary 3 times (at baseline, week 6 & week 12) during the intervention. Food diaries will be analysed using Nutritics (v.4) dietary analysis software.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Capsules were masked by the manufacturer and blinded to outcome assessors.
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 55-70 years; Normal weight (BMI 18.5-24.9 Kg/m2) and overweight (BMI 25- 29.9 Kg/m2); All genders; No diagnosed metabolic diseases.
排除标准
- •Participants who have been on a weight loss regimen over the past 2 months, those with diagnosed chronic disease (diabetes, cardiovascular disease (CVD), renal disease etc...) or taking any medications that could modulate inflammation (statins etc..).
结局指标
主要结局
Interleukin-6 (IL-6) levels
时间窗: Baseline, week 6 & week 12
Changes in IL-6 levels will be measured in a fasted blood sample using a commercially available assay kit.
次要结局
- Chair sit to stand(Baseline, week 6 & week 12)
- Interleukin 1 (IL-1) levels(Baseline, week 6 & week 12)
- Insulin growth factor-1 (IGF-1) levels(Baseline, week 6 & week 12)
- Wisconsin test(Baseline, week 6 & week 12)
- Hand grip strength(Baseline, week 6 & week 12)
- Standing balance(Baseline, week 6 & week 12)
- Gait speed(Baseline, week 6 & week 12)
- Fasting serum glucose levels(Baseline, week 6 & week 12)
- CRP (C-reactive protein) levels(Baseline, week 6 & week 12)
- Interleukin 2 (IL-2) levels(Baseline, week 6 & week 12)
- Telomerase activity(Baseline, week 6 & week 12)
- Corsi block-tapping test(Baseline, week 6 & week 12)
- Tower of Hanoi test(Baseline, week 6 & week 12)
- Stroop test(Baseline, week 6 & week 12)
- Digits span test(Baseline, week 6 & week 12)
- Tumour necrosis factor (TNF-α) levels(Baseline, week 6 & week 12)
- Plasminogen Activator Inhibitor-1 (PAI-1) levels(Baseline, week 6 & week 12)
- Rey Verbal Learning test(Baseline, week 6 & week 12)
- Fasting lipid levels(Baseline, week 6 & week 12)
- Blood pressure(Baseline, week 6 & week 12)
研究者
Grace Farhat
Senior lecturer in Nutrition and Dietetics
Manchester Metropolitan University