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NCT Number: NCT03611114

The Impact of Citrus Products on Cardiovascular Health

Epidemiological studies have indicated that the consumption of citrus fruit is inversely associated with the risk of cardiovascular disease. However, clinical data regarding the effects of blood orange juice upon endothelial function is scarce. This randomised, crossover study investigates whether blood orange juice compared to a control drink improves blood vessel function and other cardiovascular health indicators (such as blood pressure and blood lipids). All the subjects will be asked to consume blood orange juice and a control drink in a randomised order, each over a 2-week period, divided by a 1-week wash out period.

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Key information

Conditions

Healthy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Leeds

Leeds, LS2 9JT, United Kingdom

About this study

Endothelial function measured via flow mediated dilation (FMD), blood pressure, anthropometric measures, lipid profile, high-sensitivity C-reactive protein (hsCRP) and endothelin 1 (ET-1), cyclic guanosine monophosphate (cGMP) will be evaluated in healthy overweight/obese Caucasians prior to and following 2-week consumption of blood orange juice and a control drink. Evaluation of endothelial function as measured by FMD will be conducted on specific days of the menstrual cycle to minimise the fluctuation in oestrogen levels in premenopausal women, which will be monitored in serum samples.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generally healthy
  • Caucasians (of European origin)
  • BMI > 25 kg/m2

Exclusion criteria

  • Presence of cardiovascular diseases
  • Smoking
  • Use of medications or dietary supplements (vitamins, antioxidants)
  • On a special diet and/or a training program to change weight

Treatment and study plan

Blood orange juice

Dietary Supplement

Control drink

Dietary Supplement

Primary outcomes

  1. Changes in flow mediated dilation between baseline and endpoint within the intervention group vs. control group

    Time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.

    FMD will be evaluated prior to and following 2-week consumption of either blood orange juice or a control drink.

Secondary outcomes

  1. Changes in blood pressure between baseline and endpoint within the intervention group vs. control group

    Time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.

    Blood pressure will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.

  2. Changes in lipid profile between baseline and endpoint within the intervention group vs. control group

    Time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.

    Serum total cholesterol, HDL cholesterol, LDL cholesterol will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.

  3. Changes in high sensitivity C-reactive protein between baseline and endpoint within the intervention group vs. control group

    Time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.

    Serum hsCRP will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.

  4. Changes in endothelin-1 (ET-1) between baseline and endpoint within the intervention group vs. control group

    Time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.

    Serum ET-1 will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.

  5. Changes in oestradiol between baseline and endpoint within the intervention group vs. control group

    Time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.

    Serum oestradiol will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.

  6. Changes in flavanone metabolites between baseline and endpoint within the intervention group vs. control group

    Time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.

    Flavanone metabolites will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.

  7. Changes in cyclic guanosine monophosphate (cGMP) between baseline and endpoint within the intervention group vs. control group

    Time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.

    Cyclic guanosine monophosphate (cGMP) will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Registry information

Official study title

Effects of Blood Orange Juice Consumption on Endothelial Function in Healthy Overweight/Obese Men and Premenopausal Women of European Origin

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 2, 2018
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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