Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers

NCT06042673 | Recruiting

• 1 other identifier: UREC 22/11
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Fasting blood lipids

  Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes

• Change from baseline in postprandial 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

  Acute study: taken at 0 (baseline),180, 300 and 420 minutes

• Change from baseline in postprandial blood pressure

  Acute study: taken at 0 (baseline), 120, 240, 360 and 480 minutes

• Change from baseline endothelial microvascular function

  Acute study: taken at 0 (baseline),180, 300 and 420 minutes

Study Arms (2)

Pomegranate seed oil

EXPERIMENTAL

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

Dietary Supplement: Pomegranate seed oil

mixed vegetable oil

PLACEBO COMPARATOR

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

Dietary Supplement: Mixed vegetable oil

Interventions

Pomegranate seed oil 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

Pomegranate seed oil

Mixed vegetable oil 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

mixed vegetable oil

Eligibility Criteria

• Age: Up to 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

Department of Food and Nutritional Sciences, University of Reading

Reading, RG6 6AP, United Kingdom

RECRUITING

Related Publications (1)

• Almoraie MM, Spencer JPE, Wagstaff C, Jackson KG. Acute Effects of a High-Fat Meal Enriched with Pomegranate Seed Oil on Postprandial Lipemia and Endothelial Function in Postmenopausal Women: A Randomized Controlled Crossover Trial. J Nutr. 2026 Jan 22:101374. doi: 10.1016/j.tjnut.2026.101374. Online ahead of print.

  PMID: 41580088 DERIVED

MeSH Terms

Interventions

Nano-PSO

Central Study Contacts

Jeremy Spencer, BSc, PhD

CONTACT

+44(0)1183788724; j.p.e.spencer@reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 18, 2023
• Study Start: July 6, 2023
• Primary Completion: February 20, 2024
• Study Completion: July 28, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

GB (1)