Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers in Postmenopausal Women.

Conditions
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Postmenopausal Women

Intervention / Treatment
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* Dietary Supplement: Pomegranate seed oil
* Dietary Supplement: Mixed vegetable oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) 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

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pomegranate seed oil<br>Participants will be asked to consume breakfast (0 minute) containing pomegranate seed oil | Dietary Supplement: Pomegranate seed oil<br>* 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<br>|
| Placebo Comparator: mixed vegetable oil<br>Participants will be asked to consume breakfast (0 minute) containing mixed vegetable oil | Dietary Supplement: Mixed vegetable oil<br>* 50g mixed oil (palm oil/ rapeseed oil/ safflower oil (4:0.5:0.5)) will be added to the test meal for breakfast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in postprandial triacylglycerol | Triacylglycerol | Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood lipids | Total cholesterol, high density lipoprotein cholesterol | Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes | 
| Change from baseline in postprandial insulin | Insulin | 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 | 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 | Acute study: taken at 0 (baseline), 120, 240, 360 and 480 minutes | 
| Change from baseline endothelial microvascular function | Laser Doppler imaging (LDI) with iontophoresis | Acute study: taken at 0 (baseline),180, 300 and 420 minutes |