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The Effects of Orange Juice on Plasma Lipids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01350843
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : March 27, 2018
Florida Department of Citrus
Information provided by (Responsible Party):
Elizabeth Simpson, University of Nottingham

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Obesity Dyslipidemia Dietary Supplement: Orange Juice Not Applicable

Detailed Description:


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.


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: An Investigation Into the Effects of Orange Juice on Plasma Lipids - an Extension to J/06/2010
Study Start Date : May 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Orange Juice
Juice high in flavonoids
Dietary Supplement: Orange Juice
250ml of orange juice or a sugars matched orange drink daily

Placebo Comparator: Orange Drink
Sugars matched, low flavonoids orange drink
Dietary Supplement: Orange Juice
250ml of orange juice or a sugars matched orange drink daily

Primary Outcome Measures :
  1. Total Serum Cholesterol concentration [ Time Frame: after 3 months' intervention ]
    Fasting Serum total cholesterol concentration (mmol/l)

Secondary Outcome Measures :
  1. High Density Cholesterol (HDL) [ Time Frame: after 3 months' intervention ]
    Fasting Serum HDL concentration

  2. Low density cholesterol [ Time Frame: after 3 months' intervention ]
    Fasting Serum LDL concentration

  3. Gene expression in adipose tissue [ Time Frame: after 3 months' intervention ]
    Expression of genes related to lipid metabolism in adipose tissue

  4. leptin [ Time Frame: after 3 month intervention ]
    fasting Serum Leptin concentration

  5. IL-1 [ Time Frame: afetr 3 month intervention ]
    Serum IL-1 concentration

  6. Blood Pressure [ Time Frame: after 3months intervention ]
    Resting blood pressure, measured semi-supine

  7. Ghrelin [ Time Frame: After 3 months intervention ]
    Fasting Plasma Ghrelin concentration

  8. GLP-1 [ Time Frame: After 3 months intervention ]
    Fasting Plasma GLP-1 concentration

  9. insulin [ Time Frame: After 3 months intervention ]
    Fasting serum Insulin concentration

  10. IL-6 [ Time Frame: After 3 months intervention ]
    Serum IL-6 concentration

  11. TNF alpha [ Time Frame: After 3 months intervention ]
    Serum TNF-Alpha concentration

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01350843

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United Kingdom
David Greenfield Human Physiology Unit, University of Nottingham
Nottingham, Notts, United Kingdom, NG72UH
Sponsors and Collaborators
University of Nottingham
Florida Department of Citrus
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Principal Investigator: Ian A Macdonald, PhD Nottingham University
Publications of Results:
Other Publications:
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Responsible Party: Elizabeth Simpson, Senior Research Fellow, University of Nottingham Identifier: NCT01350843    
Other Study ID Numbers: RIS 100058b
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Elizabeth Simpson, University of Nottingham:
Orange Juice
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders