Postmenopausal WomenNCT06042673
Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers
A study testing Pomegranate seed oil and Mixed vegetable oil in people with Postmenopausal Women, run by University of Reading at 1 site in United Kingdom.
Trial summary
Dietary fat plays a crucial role as a modifiable risk factor influencing both non-fasting lipaemia and vascular reactivity. Notably, the intake of dietary saturated fatty acids (SFAs) has been associated with adverse effects on blood lipid profiles, whereas increased consumption of unsaturated fatty acids (UFAs) has… Read more about this study
- Who is it for?
- Ages Up to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- Pomegranate seed oil and Mixed vegetable oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jul 2023to 28 Jul 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 Up to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women who have been postmenopausal for at least 12 months.
- Aged 65 and under years
- Serum TAG < 2.3 mmol/l
- Body mass index (BMI) between 18-35 kg/m2
- Fasting total cholesterol < 7.5 mmol/l
- Fasting glucose concentration <7 mmol/L
Who cannot join
- Smokers
- Medical history of myocardial infarction or stroke in the past 12 months
- Diabetes (defined as fasting glucose > 7.0 mmol/l) or other endocrine disorders
- Kidney, liver, pancreas or gastrointestinal disorder
- Hypertension (blood pressure > 140/90 mmHg), cancer, medication for hyperlipidaemia (e.g. statins), hypertension or, inflammation
- Anaemia (<115 g/L haemoglobin)
Show all 11Show fewer
- Taking any dietary supplements known to influence lipids/gut microbiota (e.g. plant stanols, fish oil, phytochemicals, natural laxatives, probiotics and prebiotics)
- Drinking in excess of 14 units of alcohol per week
- Planning on a weight-reducing regime
- Parallel participation in another dietary intervention study
- Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention and metabolic study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Department of Food and Nutritional Sciences, University of Reading
Reading, RG6 6AP
Jeremy Spencer, BSc, PhD, j.p.e.spencer@reading.ac.uk
About this study
Official title: Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers in Postmenopausal Women.
Dietary fat plays a crucial role as a modifiable risk factor influencing both non-fasting lipaemia and vascular reactivity. Notably, the intake of dietary saturated fatty acids (SFAs) has been associated with adverse effects on blood lipid profiles, whereas increased consumption of unsaturated fatty acids (UFAs) has shown potential to improve lipid health. Pomegranate seed oil (PSO) stands out due to its high content of conjugated α-linolenic acids (CLnAs). However, research comparing the impact of these fatty acids on postprandial vascular function, particularly in postmenopausal women, remains limited. A cross-over, single-blind, randomised acute postprandial study will be conducted in 15 healthy postmenopausal women. Participants will be assigned to consume the test meals either a placebo (50 g of mixed fat; 4:0.5:0.5 palm oil: rapeseed oil: safflower oil) or PSO (40 g of mixed fat and 10g of PSO) in random order on 2 separate occasions, with 4-6 weeks between each study visit. The anthropometric, blood pressure, and arterial stiffness, will be taken for each study visit. Blood samples will be collected for the measurement of fasting lipids, glucose, insulin, inflammatory markers, and whole blood culture. The findings from this study will contribute to the evidence base on how consuming meals rich in PSO influence the level of blood lipids as well as other biomarkers for cardiovascular disease.
- Conditions
- Postmenopausal Women
- Being tested
- Pomegranate seed oil, Mixed vegetable oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate seed oilDietary supplement
10 g of pomegranate seed oil+40g mixed oil (palm oil/ rapeseed oil/ safflower oil (4:0.5:0.5)) will be added to the test meal for breakfast
Mixed vegetable oilDietary supplement
50g mixed oil (palm oil/ rapeseed oil/ safflower oil (4:0.5:0.5)) will be added to the test meal for breakfast
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate seed oil | Experimental | Participants will be asked to consume breakfast (0 minute) containing pomegranate seed oil Receives: Dietary Supplement: Pomegranate seed oil |
| mixed vegetable oil | Placebo comparator | Participants will be asked to consume breakfast (0 minute) containing mixed vegetable oil Receives: Dietary Supplement: Mixed vegetable oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in postprandial triacylglycerol
Triacylglycerol
Measured: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes
Secondary outcomes (5)
Fasting blood lipids
Total cholesterol, high density lipoprotein cholesterol
Measured: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes
Change from baseline in postprandial insulin
Insulin
Measured: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes
Change from baseline in postprandial endothelial activation
E-selectin, P-selectin, vascular cell adhesion molecule 1, intercellular adhesion molecule-1
Measured: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
Change from baseline in postprandial blood pressure
Systolic and diastolic blood pressure Systolic and diastolic blood pressure Systolic and diastolic blood pressure Systolic and diastolic blood pressure
Measured: Acute study: taken at 0 (baseline), 120, 240, 360 and 480 minutes
Change from baseline endothelial microvascular function
Laser Doppler imaging (LDI) with iontophoresis
Measured: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start6 Jul 2023
- Primary completion20 Feb 2024
- Study completion28 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal WomenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042673
- Sponsor's protocol ID
- UREC 22/11
- Status last verified
- Apr 2024
- First submitted
- 5 Sep 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Almoraie MM, Spencer JP, Wagstaff C, Jackson KG. Acute Effects of a High-Fat Meal Enriched with Pomegranate Seed Oil on Postprandial Lipemia and Endothelial Function in Postmenopausal Women: a Randomized Controlled Crossover Trial. J Nutr. 2026 Mar;156(3):101374. doi: 10.1016/j.tjnut.2026.101374. Epub 2026 Jan 22.
PubMed 41580088
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers in Postmenopausal Women.
- ClinicalTrials.gov ID
- NCT06042673
- Acronym / sponsor ID
- UREC 22/11
- Conditions
- Postmenopausal Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 28 Jul 2024 (estimated)
- First posted
- 18 Sep 2023 (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.
Dietary fat plays a crucial role as a modifiable risk factor influencing both non-fasting lipaemia and vascular reactivity. Notably, the intake of dietary saturated fatty acids (SFAs) has been associated with adverse effects on blood lipid profiles, whereas increased consumption of unsaturated fatty acids (UFAs) has shown potential to improve lipid health. Pomegranate seed oil (PSO) stands out due to its high content of conjugated α-linolenic acids (CLnAs). However, research comparing the impact of these fatty acids on postprandial vascular function, particularly in postmenopausal women, remains limited. A cross-over, single-blind, randomised acute postprandial study will be conducted in 15 healthy postmenopausal women. Participants will be assigned to consume the test meals either a placebo (50 g of mixed fat; 4:0.5:0.5 palm oil: rapeseed oil: safflower oil) or PSO (40 g of mixed fat and 10g of PSO) in random order on 2 separate occasions, with 4-6 weeks between each study visit. The anthropometric, blood pressure, and arterial stiffness, will be taken for each study visit. Blood samples will be collected for the measurement of fasting lipids, glucose, insulin, inflammatory markers, and whole blood culture. The findings from this study will contribute to the evidence base on how consuming meals rich in PSO influence the level of blood lipids as well as other biomarkers for cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomegranate seed oil | Experimental | Dietary Supplement: Pomegranate seed oilParticipants will be asked to consume breakfast (0 minute) containing pomegranate seed oil |
| mixed vegetable oil | Placebo comparator | Dietary Supplement: Mixed vegetable oilParticipants will be asked to consume breakfast (0 minute) containing mixed vegetable oil |
Who may qualify
- Ages
- Up to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal women who have been postmenopausal for at least 12 months.
- Aged 65 and under years
- Serum TAG < 2.3 mmol/l
- Body mass index (BMI) between 18-35 kg/m2
- Fasting total cholesterol < 7.5 mmol/l
Key exclusion criteria (11 listed)
- Smokers
- Medical history of myocardial infarction or stroke in the past 12 months
- Diabetes (defined as fasting glucose > 7.0 mmol/l) or other endocrine disorders
- Kidney, liver, pancreas or gastrointestinal disorder
- Hypertension (blood pressure > 140/90 mmHg), cancer, medication for hyperlipidaemia (e.g. statins), hypertension or, inflammation
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 seed oil10 g of pomegranate seed oil+40g mixed oil (palm oil/ rapeseed oil/ safflower oil (4:0.5:0.5)) will be added to the test meal for breakfast | Dietary supplement | Pomegranate seed oil |
| Mixed vegetable oil50g mixed oil (palm oil/ rapeseed oil/ safflower oil (4:0.5:0.5)) will be added to the test meal for breakfast | Dietary supplement | mixed vegetable oil |
Primary outcome
Change from baseline in postprandial triacylglycerol
Time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes
Triacylglycerol
5 secondary outcomes
Fasting blood lipids
Time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes
Change from baseline in postprandial insulin
Time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes
Change from baseline in postprandial endothelial activation
Time frame: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
Change from baseline in postprandial blood pressure
Time frame: Acute study: taken at 0 (baseline), 120, 240, 360 and 480 minutes
Change from baseline endothelial microvascular function
Time frame: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Derived from this study: PubMed 41580088Almoraie MM, Spencer JP, Wagstaff C, Jackson KG. Acute Effects of a High-Fat Meal Enriched with Pomegranate Seed Oil on Postprandial Lipemia and Endothelial Function in Postmenopausal Women: a Randomized Controlled Crossover Trial. J Nutr. 2026 Mar;156(3):101374. doi: 10.1016/j.tjnut.2026.101374. Epub 2026 Jan 22.
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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.
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 seed oil and Mixed vegetable oil in people with Postmenopausal Women, run by University of Reading 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 6 inclusion and 11 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 29 Apr 2024. 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?
Contact Jeremy Spencer, BSc, PhD (+44(0)1183788724, j.p.e.spencer@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in postprandial triacylglycerol (time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06042673, which also lists 1 linked publication.
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 29 Apr 2024.