Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers

Postmenopausal Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06042673
• Other study ID #: UREC 22/11
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2023
• Est. completion date: July 28, 2024

Study information

• Verified date: April 2024
• Source: University of Reading
• Contact: Jeremy Spencer, BSc, PhD
• Phone: +44(0)1183788724
• Email: j.p.e.spencer[@]reading.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 28, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Postmenopausal Women

Intervention

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
• 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

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences, University of Reading	Reading

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change from baseline in postprandial insulin	Insulin	Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes
Secondary	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
Secondary	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
Secondary	Change from baseline endothelial microvascular function	Laser Doppler imaging (LDI) with iontophoresis	Acute study: taken at 0 (baseline),180, 300 and 420 minutes