Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers

Sponsor

University of Reading (Other)

Overall Status

Recruiting

CT.gov ID

NCT06042673

Collaborator

(none)

Enrollment

Location

Arms

4.8

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Women	Dietary Supplement: Pomegranate seed oil Dietary Supplement: Mixed vegetable oil	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 6, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline in postprandial triacylglycerol [Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes]
Triacylglycerol

Secondary Outcome Measures

Fasting blood lipids [Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes]
Total cholesterol, high density lipoprotein cholesterol
Change from baseline in postprandial insulin [Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes]
Insulin
Change from baseline in postprandial endothelial activation [Acute study: taken at 0 (baseline),180, 300 and 420 minutes]
E-selectin, P-selectin, vascular cell adhesion molecule 1, intercellular adhesion molecule-1
Change from baseline in postprandial blood pressure [Acute study: taken at 0 (baseline), 120, 240, 360 and 480 minutes]
Systolic and diastolic blood pressure Systolic and diastolic blood pressure Systolic and diastolic blood pressure Systolic and diastolic blood pressure
Change from baseline endothelial microvascular function [Acute study: taken at 0 (baseline),180, 300 and 420 minutes]
Laser Doppler imaging (LDI) with iontophoresis

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Food and Nutritional Sciences, University of Reading	Reading		United Kingdom	RG6 6AP

Sponsors and Collaborators

University of Reading

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeremy Paul Edward Spencer, Prof, University of Reading

ClinicalTrials.gov Identifier:

NCT06042673

Other Study ID Numbers:

UREC 22/11

First Posted:

Sep 18, 2023

Last Update Posted:

Sep 18, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Sep 18, 2023