ObesityNCT02017132
Effect of Pomegranate Extract Intake on Body Composition and Blood Pressure.
A study testing Pomegranate extract in people with Obesity and Diabetes, run by Queen Margaret University at 1 site in United Kingdom.
Trial summary
Pomegranate has gained widespread popularity since the health effects of the whole fruit, as well as its juices and extracts, have been studied in relation to a variety of chronic conditions such as hypertension, diabetes, obesity, cancer and cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes, Cardiovascular Disease
- 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
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Jan 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers with a BMI within the range of 18-34.9 kg/m².
Who cannot join
- Taking medications for heart, liver or kidney disease, or diabetes;
- recent weight loss within 2 months preceding the study;
- pregnancy;
- lactation;
- allergies to pomegranate.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Margaret University
Musselburgh, Edinburgh, EH21 6UU
About this study
Official title: The Effect of Pomegranate Extract on Anthropometric, Physiological and Biochemical Parameters in Human Volunteers: an 8 Week Parallel, Double Blinded, Placebo Controlled, Randomised Trial.
Pomegranate has gained widespread popularity since the health effects of the whole fruit, as well as its juices and extracts, have been studied in relation to a variety of chronic conditions such as hypertension, diabetes, obesity, cancer and cardiovascular disease.
The fruit consists of peel, seeds and berries or arils. The peel is rich in minerals and compounds such as polyphenols, but is not an edible part of the plant. In order to harness the benefits of all parts of the fruit, the whole fruit can be crushed and powdered and then easily consumed as pomegranate extract capsules.
Read more
Pomegranate has been shown to be effective at reducing cardiovascular disease risk factors, particularly with respect to decreasing blood pressure and increasing insulin sensitivity. Dietary polyphenols may also suppress body fat growth. Recently, positive effects on fat reduction have been shown using pomegranate and its extracts. In animal models it has been shown for both extract and leaf that there were significant decrease in food consumption and body weight, inhibiting the development of obesity. In the few human studies, there appeared to be a trend towards a reduction in waist circumference and fat mass, plus a halt in body weight increase, for both juice and seed oil.
This parallel, double blinded, randomised, placebo controlled trial aims to confirm previous results concerning the effect of whole pomegranate fruit on biochemical and physiological markers using a new pomegranate extract and to conduct original work to explore its effect on body weight, measurements and fat mass. Any similar interventions have not been double blinded or used pomegranate in extract form. Changes in physiological and biochemical markers will also be investigated.
The study hypothesis is that pomegranate extract will reduce BMI and body weight, fat mass, body measurements and blood pressure.
Read the detailed description
This is a parallel, double blinded, placebo controlled, randomised trial. It will be conducted over an 8 week intervention phase, plus a pre-intervention registration and preparation period. Participants will be randomly assigned to either the pomegranate extract or placebo groups. One capsule of Pomegranate or placebo will be taken after the same time daily meal with water for 8 weeks.
Participants will be asked to visit the clinical lab three times. The first visit will be for baseline measurements and a 24 hour urine sample before the intervention begins; the second in week 4 for measurements only and the final visit in week 8 for measurements and the last urine collection. Blood pressure and anthropometric measurements will be taken at each visit. Urine will only be collected pre and post intervention.
The health related Quality of Life Questionnaire (Rand 36) will be administered at both the initial and final visits. This series of questions covers eight spheres of health and has been proven to be scientifically robust having been used in over 200 health related scientific trials.
Three day diet diaries will be used for recording energy intake and to determine any fluctuations in dietary intake over the study period. These will be completed by participants in the pre-intervention week and then at week 4 of the intervention. Participants complete 2 diet diaries in total.
- Conditions
- Obesity, Diabetes, Cardiovascular Disease
- Being tested
- Pomegranate extract
- Keywords
- Pomegranate, Blood pressure, Body composition, Weight-loss, Fat mass, Polyphenols, Quality of Life
- Medical subject headings
- Obesity, Diabetes Mellitus, Cardiovascular Diseases, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate extractDietary supplement
Also called Pomegreat PurePlus
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate extract | Active comparator | 1.1g pomegranate extract capsule administered daily to each participant for 8 weeks Receives: Dietary Supplement: Pomegranate extract |
| Placebo capsule | Placebo comparator | 1.1g placebo capsule taken daily by each participant for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in measurements of body mass indicators
These indicators are:
Body weight; height; BMI; waist, hip and mid-upper arm circumference; fat and fat free mass.
Measured: Week 0, 4, 8
Secondary outcomes (1)
Changes in blood pressure
Systolic and diastolic blood pressure are taken when volunteers are supine
Measured: Week 0, 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- PomeGreat
- Responsible party
- Principal investigator, Angela Stockton, Queen Margaret University
- Investigators
- Angela EV Stockton, MSc, Principal investigator, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017132
- Sponsor's protocol ID
- POM-02Extr
- Status last verified
- Dec 2013
- First submitted
- 16 Dec 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pomegranate Extract on Anthropometric, Physiological and Biochemical Parameters in Human Volunteers: an 8 Week Parallel, Double Blinded, Placebo Controlled, Randomised Trial.
- ClinicalTrials.gov ID
- NCT02017132
- Acronym / sponsor ID
- POM-02Extr
- Conditions
- Obesity, Diabetes, Cardiovascular Disease
- Keywords
- Pomegranate, Blood pressure, Body composition, Weight-loss, Fat mass, Polyphenols, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- PomeGreat
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 20 Dec 2013 (estimated)
- 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.
Pomegranate has gained widespread popularity since the health effects of the whole fruit, as well as its juices and extracts, have been studied in relation to a variety of chronic conditions such as hypertension, diabetes, obesity, cancer and cardiovascular disease.
The fruit consists of peel, seeds and berries or arils. The peel is rich in minerals and compounds such as polyphenols, but is not an edible part of the plant. In order to harness the benefits of all parts of the fruit, the whole fruit can be crushed and powdered and then easily consumed as pomegranate extract capsules.
Pomegranate has been shown to be effective at reducing cardiovascular disease risk factors, particularly with respect to decreasing blood pressure and increasing insulin sensitivity. Dietary polyphenols may also suppress body fat growth. Recently, positive effects on fat reduction have been shown using pomegranate and its extracts. In animal models it has been shown for both extract and leaf that there were significant decrease in food consumption and body weight, inhibiting the development of obesity. In the few human studies, there appeared to be a trend towards a reduction in waist circumference and fat mass, plus a halt in body weight increase, for both juice and seed oil.
This parallel, double blinded, randomised, placebo controlled trial aims to confirm previous results concerning the effect of whole pomegranate fruit on biochemical and physiological markers using a new pomegranate extract and to conduct original work to explore its effect on body weight, measurements and fat mass. Any similar interventions have not been double blinded or used pomegranate in extract form. Changes in physiological and biochemical markers will also be investigated.
The study hypothesis is that pomegranate extract will reduce BMI and body weight, fat mass, body measurements and blood pressure.
Detailed description
This is a parallel, double blinded, placebo controlled, randomised trial. It will be conducted over an 8 week intervention phase, plus a pre-intervention registration and preparation period. Participants will be randomly assigned to either the pomegranate extract or placebo groups. One capsule of Pomegranate or placebo will be taken after the same time daily meal with water for 8 weeks.
Participants will be asked to visit the clinical lab three times. The first visit will be for baseline measurements and a 24 hour urine sample before the intervention begins; the second in week 4 for measurements only and the final visit in week 8 for measurements and the last urine collection. Blood pressure and anthropometric measurements will be taken at each visit. Urine will only be collected pre and post intervention.
The health related Quality of Life Questionnaire (Rand 36) will be administered at both the initial and final visits. This series of questions covers eight spheres of health and has been proven to be scientifically robust having been used in over 200 health related scientific trials.
Three day diet diaries will be used for recording energy intake and to determine any fluctuations in dietary intake over the study period. These will be completed by participants in the pre-intervention week and then at week 4 of the intervention. Participants complete 2 diet diaries in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomegranate extract | Active comparator | Dietary Supplement: Pomegranate extract1.1g pomegranate extract capsule administered daily to each participant for 8 weeks |
| Placebo capsule | Placebo comparator | –1.1g placebo capsule taken daily by each participant for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers with a BMI within the range of 18-34.9 kg/m².
Key exclusion criteria (5 listed)
- Taking medications for heart, liver or kidney disease, or diabetes;
- recent weight loss within 2 months preceding the study;
- pregnancy;
- lactation;
- allergies to pomegranate.
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 extractAlso: Pomegreat PurePlus | Dietary supplement | Pomegranate extract |
Primary outcome
Changes in measurements of body mass indicators
Time frame: Week 0, 4, 8
These indicators are: Body weight; height; BMI; waist, hip and mid-upper arm circumference; fat and fat free mass.
1 secondary outcome
Changes in blood pressure
Time frame: Week 0, 4, 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
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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.
Angela EV Stockton, MSc principal investigator
Queen Margaret University
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 Obesity and Diabetes, run by Queen Margaret 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 5 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: status not confirmed, as of the sponsor's last update on 20 Dec 2013. 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?
Results are not available in the source record.
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?
Changes in measurements of body mass indicators (time frame: Week 0, 4, 8). 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 Dec 2013.