Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-06

Study Completion Date

2024-07-28

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.

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Detailed Description

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Conditions

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Postmenopausal Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pomegranate seed oil

Participants will be asked to consume breakfast (0 minute) containing pomegranate seed oil

Group Type EXPERIMENTAL

Pomegranate seed oil

Intervention Type DIETARY_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 oil

Participants will be asked to consume breakfast (0 minute) containing mixed vegetable oil

Group Type PLACEBO_COMPARATOR

Mixed vegetable oil

Intervention Type DIETARY_SUPPLEMENT

50g mixed oil (palm oil/ rapeseed oil/ safflower oil (4:0.5:0.5)) will be added to the test meal for breakfast

Interventions

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Pomegranate seed oil

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

Intervention Type DIETARY_SUPPLEMENT

Mixed vegetable oil

50g mixed oil (palm oil/ rapeseed oil/ safflower oil (4:0.5:0.5)) will be added to the test meal for breakfast

Intervention Type DIETARY_SUPPLEMENT

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

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes