AgingNCT05588479
Pomegranate Extract and Inflammageing
A study testing Pomegranate extract in people with Aging, run by Manchester Metropolitan University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Pomegranate extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Dec 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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..).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester Metropolitan University school of Health sciences
Manchester, M15 6BG
About this study
Official title: Effects of Pomegranate Extract on Inflammatory Markers, Physical and Cognitive Function and Cardiometabolic Risk Factors in Older Adults: a Randomised Parallel Trial
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Pomegranate extract, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate extractDietary supplement
Two capsules of pomegranate extract (740 mg) will be taken daily at any time of the day for a period of 12 weeks.
ControlDietary supplement
One capsule of containing no pomegranate extract will be taken daily at any time of the day for a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Capsules with no pomegranate extract One capsule to be administered once a day for 12 weeks. Receives: Dietary Supplement: Control |
| Intervention | Experimental | Capsules with 740 mg of pomegranate extract Two capsules to be administered once a day for 12 weeks. Receives: Dietary Supplement: Pomegranate extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6 (IL-6) levels
Changes in IL-6 levels will be measured in a fasted blood sample using a commercially available assay kit.
Measured: Baseline, week 6 & week 12
Secondary outcomes (20)
CRP (C-reactive protein) levels
Changes in CRP levels will be measured in a fasted blood sample using a commercially available assay kit.
Measured: Baseline, week 6 & week 12
Interleukin 1 (IL-1) levels
Changes in IL-1 levels will be measured in a fasted blood sample using a commercially available assay kit.
Measured: Baseline, week 6 & week 12
Interleukin 2 (IL-2) levels
Changes in IL-2 levels will be measured in a fasted blood sample using a commercially available assay kit.
Measured: Baseline, week 6 & week 12
Insulin growth factor-1 (IGF-1) levels
Changes in IGF-1 levels will be measured in a fasted blood sample using a commercially available assay kit.
Measured: Baseline, week 6 & week 12
Tumour necrosis factor (TNF-α) levels
Changes in TNF-α levels will be measured in a fasted blood sample using a commercially available assay kit.
Measured: Baseline, week 6 & week 12
Plasminogen Activator Inhibitor-1 (PAI-1) levels
Changes in PAI-1 levels will be measured in a fasted blood sample using a commercially available assay kit.
Measured: Baseline, week 6 & week 12
Telomerase activity
Changes in telomerase activity will be measured in a fasted blood sample using a commercially available assay kit.
Measured: Baseline, week 6 & week 12
Corsi block-tapping test
Changes in working memory will be assessed using Corsi block-tapping computerised cognitive test.
Measured: Baseline, week 6 & week 12
Rey Verbal Learning test
Changes in working memory will be assessed using Rey Verbal Learning computerised cognitive test.
Measured: Baseline, week 6 & week 12
Tower of Hanoi test
Changes in executive function will be assessed using Tower of Hanoi computerised cognitive test.
Measured: Baseline, week 6 & week 12
Wisconsin test
Changes in executive function will be assessed using Wisconsin computerised cognitive test.
Measured: Baseline, week 6 & week 12
Stroop test
Changes in executive function will be assessed using Stroop computerised cognitive test.
Measured: Baseline, week 6 & week 12
Digits span test
Changes in working memory will be assessed using Digits span computerised cognitive test.
Measured: Baseline, week 6 & week 12
Hand grip strength
Changes in muscle strength will be assessed using hand grip strength physical test.
Measured: Baseline, week 6 & week 12
Standing balance
Changes in muscle function will be assessed using standing balance physical test.
Measured: Baseline, week 6 & week 12
Gait speed
Changes in muscle function will be assessed using gait speed physical test.
Measured: Baseline, week 6 & week 12
Chair sit to stand
Changes in muscle function will be assessed using chair sit to stand physical test.
Measured: Baseline, week 6 & week 12
Fasting serum glucose levels
Changes in glucose levels will be measured in a fasted blood sample using a commercially available assay kit.
Measured: Baseline, week 6 & week 12
Fasting lipid levels
Changes in lipid levels (TC, HDL, LDL \& TG) will be measured in a fasted blood sample using a commercially available assay kit.
Measured: Baseline, week 6 & week 12
Blood pressure
Changes in blood pressure will be Blood pressure will be measured 3 times after a 10-minute rest based on the WHO protocol.
Measured: Baseline, week 6 & week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start10 Dec 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Farhat, Manchester Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588479
- Sponsor's protocol ID
- 47627
- Status last verified
- Jan 2025
- First submitted
- 12 Oct 2022
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pomegranate Extract on Inflammatory Markers, Physical and Cognitive Function and Cardiometabolic Risk Factors in Older Adults: a Randomised Parallel Trial
- ClinicalTrials.gov ID
- NCT05588479
- Acronym / sponsor ID
- 47627
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: ControlCapsules with no pomegranate extract One capsule to be administered once a day for 12 weeks. |
| Intervention | Experimental | Dietary Supplement: Pomegranate extractCapsules with 740 mg of pomegranate extract Two capsules to be administered once a day for 12 weeks. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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..).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomegranate extractTwo capsules of pomegranate extract (740 mg) will be taken daily at any time of the day for a period of 12 weeks. | Dietary supplement | Intervention |
| ControlOne capsule of containing no pomegranate extract will be taken daily at any time of the day for a period of 12 weeks. | Dietary supplement | Control |
Primary outcome
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.
20 secondary outcomes
CRP (C-reactive protein) levels
Time frame: Baseline, week 6 & week 12
Interleukin 1 (IL-1) levels
Time frame: Baseline, week 6 & week 12
Interleukin 2 (IL-2) levels
Time frame: Baseline, week 6 & week 12
Insulin growth factor-1 (IGF-1) levels
Time frame: Baseline, week 6 & week 12
Tumour necrosis factor (TNF-α) levels
Time frame: Baseline, week 6 & week 12
Plasminogen Activator Inhibitor-1 (PAI-1) levels
Time frame: Baseline, week 6 & week 12
Telomerase activity
Time frame: Baseline, week 6 & week 12
Corsi block-tapping test
Time frame: Baseline, week 6 & week 12
Rey Verbal Learning test
Time frame: Baseline, week 6 & week 12
Tower of Hanoi test
Time frame: Baseline, week 6 & week 12
Wisconsin test
Time frame: Baseline, week 6 & week 12
Stroop test
Time frame: Baseline, week 6 & week 12
Digits span test
Time frame: Baseline, week 6 & week 12
Hand grip strength
Time frame: Baseline, week 6 & week 12
Standing balance
Time frame: Baseline, week 6 & week 12
Gait speed
Time frame: Baseline, week 6 & week 12
Chair sit to stand
Time frame: Baseline, week 6 & week 12
Fasting serum glucose levels
Time frame: Baseline, week 6 & week 12
Fasting lipid levels
Time frame: Baseline, week 6 & week 12
Blood pressure
Time frame: Baseline, week 6 & week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomegranate extract in people with Aging, run by Manchester Metropolitan University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 (IL-6) levels (time frame: Baseline, week 6 & week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.