Clinical trial NCT05588479: Pomegranate Extract and Inflammageing
Official title: Effects of Pomegranate Extract on Inflammatory Markers, Physical and Cognitive Function and Cardiometabolic Risk Factors in Older Adults: a Randomised Parallel Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Manchester Metropolitan University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 86
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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..).

Primary outcomes:
measure: Interleukin-6 (IL-6) levels
timeFrame: Baseline, week 6 & week 12
Secondary outcomes:
measure: CRP (C-reactive protein) levels
timeFrame: Baseline, week 6 & week 12
measure: Interleukin 1 (IL-1) levels
timeFrame: Baseline, week 6 & week 12
measure: Interleukin 2 (IL-2) levels
timeFrame: Baseline, week 6 & week 12
measure: Insulin growth factor-1 (IGF-1) levels
timeFrame: Baseline, week 6 & week 12
measure: Tumour necrosis factor (TNF-α) levels
timeFrame: Baseline, week 6 & week 12
measure: Plasminogen Activator Inhibitor-1 (PAI-1) levels
timeFrame: Baseline, week 6 & week 12
measure: Telomerase activity
timeFrame: Baseline, week 6 & week 12
measure: Corsi block-tapping test
timeFrame: Baseline, week 6 & week 12
measure: Rey Verbal Learning test
timeFrame: Baseline, week 6 & week 12
measure: Tower of Hanoi test
timeFrame: Baseline, week 6 & week 12
measure: Wisconsin test
timeFrame: Baseline, week 6 & week 12
measure: Stroop test
timeFrame: Baseline, week 6 & week 12
measure: Digits span test
timeFrame: Baseline, week 6 & week 12
measure: Hand grip strength
timeFrame: Baseline, week 6 & week 12
measure: Standing balance
timeFrame: Baseline, week 6 & week 12
measure: Gait speed
timeFrame: Baseline, week 6 & week 12
measure: Chair sit to stand
timeFrame: Baseline, week 6 & week 12
measure: Fasting serum glucose levels
timeFrame: Baseline, week 6 & week 12
measure: Fasting lipid levels
timeFrame: Baseline, week 6 & week 12
measure: Blood pressure
timeFrame: Baseline, week 6 & week 12
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Metropolitan University school of Health sciences
Study officials:
References: