Aging
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPomegranate extract
Two capsules of pomegranate extract (740 mg) will be taken daily at any time of the day for a period of 12 weeks.
DIETARY_SUPPLEMENTControl
One capsule of containing no pomegranate extract will be taken daily at any time of the day for a period of 12 weeks.
Sponsors
Manchester Metropolitan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Capsules were masked by the manufacturer and blinded to outcome assessors.
Intervention model description
Two-arm double blind parallel trial where participants will be randomly assigned to receive either placebo capsules (control) or pomegranate extract capsules (740 mg) for 12 weeks.
Eligibility
Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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..).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-6 (IL-6) levels | Baseline, week 6 & week 12 | Changes in IL-6 levels will be measured in a fasted blood sample using a commercially available assay kit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin 1 (IL-1) levels | Baseline, week 6 & week 12 | Changes in IL-1 levels will be measured in a fasted blood sample using a commercially available assay kit. |
| Interleukin 2 (IL-2) levels | Baseline, week 6 & week 12 | Changes in IL-2 levels will be measured in a fasted blood sample using a commercially available assay kit. |
| Insulin growth factor-1 (IGF-1) levels | Baseline, week 6 & week 12 | Changes in IGF-1 levels will be measured in a fasted blood sample using a commercially available assay kit. |
| Tumour necrosis factor (TNF-α) levels | Baseline, week 6 & week 12 | Changes in TNF-α levels will be measured in a fasted blood sample using a commercially available assay kit. |
| Plasminogen Activator Inhibitor-1 (PAI-1) levels | Baseline, week 6 & week 12 | Changes in PAI-1 levels will be measured in a fasted blood sample using a commercially available assay kit. |
| Telomerase activity | Baseline, week 6 & week 12 | Changes in telomerase activity will be measured in a fasted blood sample using a commercially available assay kit. |
| Corsi block-tapping test | Baseline, week 6 & week 12 | Changes in working memory will be assessed using Corsi block-tapping computerised cognitive test. |
| Rey Verbal Learning test | Baseline, week 6 & week 12 | Changes in working memory will be assessed using Rey Verbal Learning computerised cognitive test. |
| Tower of Hanoi test | Baseline, week 6 & week 12 | Changes in executive function will be assessed using Tower of Hanoi computerised cognitive test. |
| CRP (C-reactive protein) levels | Baseline, week 6 & week 12 | Changes in CRP levels will be measured in a fasted blood sample using a commercially available assay kit. |
| Stroop test | Baseline, week 6 & week 12 | Changes in executive function will be assessed using Stroop computerised cognitive test. |
| Digits span test | Baseline, week 6 & week 12 | Changes in working memory will be assessed using Digits span computerised cognitive test. |
| Hand grip strength | Baseline, week 6 & week 12 | Changes in muscle strength will be assessed using hand grip strength physical test. |
| Standing balance | Baseline, week 6 & week 12 | Changes in muscle function will be assessed using standing balance physical test. |
| Gait speed | Baseline, week 6 & week 12 | Changes in muscle function will be assessed using gait speed physical test. |
| Chair sit to stand | Baseline, week 6 & week 12 | Changes in muscle function will be assessed using chair sit to stand physical test. |
| Fasting serum glucose levels | Baseline, week 6 & week 12 | Changes in glucose levels will be measured in a fasted blood sample using a commercially available assay kit. |
| Fasting lipid levels | Baseline, week 6 & week 12 | Changes in lipid levels (TC, HDL, LDL & TG) will be measured in a fasted blood sample using a commercially available assay kit. |
| Blood pressure | Baseline, week 6 & week 12 | Changes in blood pressure will be Blood pressure will be measured 3 times after a 10-minute rest based on the WHO protocol. |
| Wisconsin test | Baseline, week 6 & week 12 | Changes in executive function will be assessed using Wisconsin computerised cognitive test. |
Countries
United Kingdom
Outcome results
None listed