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Completed

NCT Number: NCT05588479

Pomegranate Extract and Inflammageing

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.

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Key information

Conditions

Aging

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manchester Metropolitan University school of Health sciences

Manchester, M15 6BG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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..).

Treatment and study plan

Pomegranate extract

Dietary Supplement

Two capsules of pomegranate extract (740 mg) will be taken daily at any time of the day for a period of 12 weeks.

Control

Dietary Supplement

One capsule of containing no pomegranate extract will be taken daily at any time of the day for a period of 12 weeks.

Primary outcomes

  1. Interleukin-6 (IL-6) levels

    Time frame: 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 outcomes

  1. CRP (C-reactive protein) levels

    Time frame: Baseline, week 6 & week 12

    Changes in CRP levels will be measured in a fasted blood sample using a commercially available assay kit.

  2. Interleukin 1 (IL-1) levels

    Time frame: Baseline, week 6 & week 12

    Changes in IL-1 levels will be measured in a fasted blood sample using a commercially available assay kit.

  3. Interleukin 2 (IL-2) levels

    Time frame: Baseline, week 6 & week 12

    Changes in IL-2 levels will be measured in a fasted blood sample using a commercially available assay kit.

  4. Insulin growth factor-1 (IGF-1) levels

    Time frame: Baseline, week 6 & week 12

    Changes in IGF-1 levels will be measured in a fasted blood sample using a commercially available assay kit.

  5. Tumour necrosis factor (TNF-α) levels

    Time frame: Baseline, week 6 & week 12

    Changes in TNF-α levels will be measured in a fasted blood sample using a commercially available assay kit.

  6. Plasminogen Activator Inhibitor-1 (PAI-1) levels

    Time frame: Baseline, week 6 & week 12

    Changes in PAI-1 levels will be measured in a fasted blood sample using a commercially available assay kit.

  7. Telomerase activity

    Time frame: Baseline, week 6 & week 12

    Changes in telomerase activity will be measured in a fasted blood sample using a commercially available assay kit.

  8. Corsi block-tapping test

    Time frame: Baseline, week 6 & week 12

    Changes in working memory will be assessed using Corsi block-tapping computerised cognitive test.

  9. Rey Verbal Learning test

    Time frame: Baseline, week 6 & week 12

    Changes in working memory will be assessed using Rey Verbal Learning computerised cognitive test.

  10. Tower of Hanoi test

    Time frame: Baseline, week 6 & week 12

    Changes in executive function will be assessed using Tower of Hanoi computerised cognitive test.

  11. Wisconsin test

    Time frame: Baseline, week 6 & week 12

    Changes in executive function will be assessed using Wisconsin computerised cognitive test.

  12. Stroop test

    Time frame: Baseline, week 6 & week 12

    Changes in executive function will be assessed using Stroop computerised cognitive test.

  13. Digits span test

    Time frame: Baseline, week 6 & week 12

    Changes in working memory will be assessed using Digits span computerised cognitive test.

  14. Hand grip strength

    Time frame: Baseline, week 6 & week 12

    Changes in muscle strength will be assessed using hand grip strength physical test.

  15. Standing balance

    Time frame: Baseline, week 6 & week 12

    Changes in muscle function will be assessed using standing balance physical test.

  16. Gait speed

    Time frame: Baseline, week 6 & week 12

    Changes in muscle function will be assessed using gait speed physical test.

  17. Chair sit to stand

    Time frame: Baseline, week 6 & week 12

    Changes in muscle function will be assessed using chair sit to stand physical test.

  18. Fasting serum glucose levels

    Time frame: Baseline, week 6 & week 12

    Changes in glucose levels will be measured in a fasted blood sample using a commercially available assay kit.

  19. Fasting lipid levels

    Time frame: 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.

  20. Blood pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Manchester Metropolitan University

Other

Registry information

Official study title

Effects of Pomegranate Extract on Inflammatory Markers, Physical and Cognitive Function and Cardiometabolic Risk Factors in Older Adults: a Randomised Parallel Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 20, 2022
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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