Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers

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.

Study Overview

• Status: Recruiting
• Conditions: Postmenopausal Women
• Intervention / Treatment: Dietary supplement: Pomegranate seed oil; Dietary supplement: Mixed vegetable oil

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeremy Spencer, BSc, PhD; Phone Number: +44(0)1183788724; Email: j.p.e.spencer@reading.ac.uk

Study Locations

• United Kingdom
  • Reading, United Kingdom, RG6 6AP
    • Recruiting
    • Department of Food and Nutritional Sciences, University of Reading
    • Contact: Jeremy Spencer, BSc, PhD; Email: j.p.e.spencer@reading.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pomegranate seed oil; Participants will be asked to consume breakfast (0 minute) containing pomegranate seed oil	Dietary supplement: 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
Placebo Comparator: mixed vegetable oil; Participants will be asked to consume breakfast (0 minute) containing mixed vegetable oil	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

What is the study measuring?

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
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
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 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

Collaborators and Investigators

• Sponsor: University of Reading

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Actual): February 20, 2024
• Study Completion (Estimated): July 28, 2024

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 16, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: UREC 22/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No