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The Impact of Citrus Products on Cardiovascular Health

U

University of Leeds

Status

Completed

Conditions

Healthy
Overweight and Obesity

Treatments

Dietary Supplement: Blood orange juice
Dietary Supplement: Control drink

Study type

Interventional

Funder types

Other

Identifiers

NCT03611114
BIOSCI 15-030

Details and patient eligibility

About

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.

Full description

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.

Enrollment

16 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

16 participants in 2 patient groups, including a placebo group

Blood orange juice
Experimental group
Description:
Subjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks.
Treatment:
Dietary Supplement: Blood orange juice
Control drink
Placebo Comparator group
Description:
Subjects will be asked to consume a control drink (400 ml/day) for 2 weeks.
Treatment:
Dietary Supplement: Control drink

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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