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The Effects of Orange Juice on Plasma Lipids

An Investigation Into the Effects of Orange Juice on Plasma Lipids - an Extension to J/06/2010

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01350843
Enrollment
36
Registered
2011-05-10
Start date
2011-05-31
Completion date
2013-02-28
Last updated
2018-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Insulin Resistance, Obesity

Keywords

Men, Orange Juice, Cholesterol, Obesity

Brief summary

The aim of this study is primarily to investigate the ability of antioxidants found in orange juice (OJ) to improve the serum lipid profile. Overweight or mildly obese men, who are otherwise healthy, but with elevated serum total cholesterol concentration will be recruited. The time commitment for subjects is \ 14wks. Subjects will attend the laboratory on 5 occasions after fasting from midnight. The 1st is a medical screening. Laboratory visits 2 & 5 will take \ 90min and will be separated by 3 months, during which time subjects will consume 250ml of an orange drink (either OJ or an orange flavoured control drink) once a day. During visits 2 & 5, subjects will have a scan to assess their %body fat using a low-dose x-ray machine, a 20ml blood sample taken and a small sample of fat tissue (about the size of a haricot bean)taken from underneath the skin of the belly. Subjects will record their food intake for 3-days in weeks 3, 7 and 11 of consuming the drink, and come to the lab for visits 3&4 during weeks 4&8. Laboratory visits 3&4 repeat measurements taken in the 1st (screening) visit.

Detailed description

Background: Overweight and mild obesity are associated with insulin resistance and mild elevations in lipid risk factors which are not usually sufficiently abnormal to merit treatment. Such people are encouraged to lose weight to reduce their risk of progressing to type 2 diabetes and coronary heart disease, but there is clearly a potential role for dietary modifications to maximize any potential benefit of this weight loss. Flavonoids are known to have vascular effects which might enhance substrate delivery to metabolically active tissues, and thus improve insulin sensitivity. Moreover, there is much interest in the potentially beneficial effect of flavonoids on serum lipid profile. There are many different dietary sources of flavonoids, with fruits such as apples, berries and citrus being rich sources. However, some researchers have expressed concern that a high dietary intake of 100% juice may contribute to the development of insulin resistance, obesity and the Metabolic Syndrome (Bazzano, Li et al. 2008), although this is not universally accepted (Fujioka, Greenway et al. 2006; O'Neil and Nicklas 2008). To date, there have been no studies investigating the effects of citrus fruits on indices of cardio-metabolic health in people who are presently healthy but are at risk of developing some features of the Metabolic Syndrome. Aims: To investigate the effects of orange juice (OJ) intake on appetite hormones, blood pressure and plasma lipids. In addition we aim to investigate any gene expression changes associated with OJ consumption, in particular in adipose tissue. Experimental protocol and methods: Overweight or obese men (BMI 27-35), who are otherwise healthy, will be recruited onto the study. They will attend the 'David Greenfield Human Physiology' laboratories on 5 convenient mornings, following an overnight fast. The 1st visit is a medical screening and will involve signing a consent form, completing medical screening, food frequency and activity questionnaires, having height, weight, and hip/waist circumference measurements taken and a sample of blood taken for CBC, urea, electrolytes, LFT, TFT, glucose and insulin analysis. Subjects will then be asked to complete a 3-day diet diary for macronutrient assessment. The 2nd visit will involve having a DEXA body composition scan, an adipose tissue biopsy and a blood sample taken for white blood cell harvest, serum lipids, glucose, insulin, cytokines, appetite hormones and catecholamine analysis. Starting on the following morning, subjects will then consume an orange drink (either OJ or a carbohydrate matched orange flavoured drink) once a day for 12 wks. A 3-day diet diary for macronutrient assessment will be recorded during wks 3,7and 11 of taking the drink, and measurements made at screening will be repeated on visits 3 and 4 which will take place in weeks 4 and 8. The final laboratory (5th) visit will be identical to visit 2.

Interventions

DIETARY_SUPPLEMENTOrange Juice

250ml of orange juice or a sugars matched orange drink daily

Sponsors

Florida Department of Citrus
CollaboratorOTHER
University of Nottingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
40 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI 27-35 * waist circumference \>96cm. * Serum Total Cholesterol \>5mmol/l

Exclusion criteria

* Any clinically significant metabolic or endocrine abnormalities * screening blood results (other than lipids) outside of the normal range * fasting total cholesterol \>7.0mmol/l * taking routine medication * herbal supplement use * food allergies or sensitivities related to the investigational product Regular citrus consumers (whole fruit or juice) daily consumption of sucrose or high fructose corn syrup containing soft-drinks

Design outcomes

Primary

MeasureTime frameDescription
Total Serum Cholesterol concentrationafter 3 months' interventionFasting Serum total cholesterol concentration (mmol/l)

Secondary

MeasureTime frameDescription
Low density cholesterolafter 3 months' interventionFasting Serum LDL concentration
Gene expression in adipose tissueafter 3 months' interventionExpression of genes related to lipid metabolism in adipose tissue
leptinafter 3 month interventionfasting Serum Leptin concentration
IL-1afetr 3 month interventionSerum IL-1 concentration
Blood Pressureafter 3months interventionResting blood pressure, measured semi-supine
High Density Cholesterol (HDL)after 3 months' interventionFasting Serum HDL concentration
GLP-1After 3 months interventionFasting Plasma GLP-1 concentration
insulinAfter 3 months interventionFasting serum Insulin concentration
IL-6After 3 months interventionSerum IL-6 concentration
TNF alphaAfter 3 months interventionSerum TNF-Alpha concentration
GhrelinAfter 3 months interventionFasting Plasma Ghrelin concentration

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026