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The Effects of Orange Juice on Plasma Lipids

This study has been completed.
Sponsor:
Collaborator:
Florida Department of Citrus
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01350843
First received: May 9, 2011
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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 Intervention
Insulin Resistance
Obesity
Dyslipidemia
Dietary Supplement: Orange Juice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: An Investigation Into the Effects of Orange Juice on Plasma Lipids - an Extension to J/06/2010

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Total Serum Cholesterol concentration [ Time Frame: after 3 months' intervention ] [ Designated as safety issue: No ]
    Fasting Serum total cholesterol concentration (mmol/l)


Secondary Outcome Measures:
  • High Density Cholesterol (HDL) [ Time Frame: after 3 months' intervention ] [ Designated as safety issue: No ]
    Fasting Serum HDL concentration

  • Low density cholesterol [ Time Frame: after 3 months' intervention ] [ Designated as safety issue: No ]
    Fasting Serum LDL concentration

  • Gene expression in adipose tissue [ Time Frame: after 3 months' intervention ] [ Designated as safety issue: No ]
    Expression of genes related to lipid metabolism in adipose tissue

  • leptin [ Time Frame: after 3 month intervention ] [ Designated as safety issue: No ]
    fasting Serum Leptin concentration

  • IL-1 [ Time Frame: afetr 3 month intervention ] [ Designated as safety issue: No ]
    Serum IL-1 concentration

  • Blood Pressure [ Time Frame: after 3months intervention ] [ Designated as safety issue: No ]
    Resting blood pressure, measured semi-supine

  • Ghrelin [ Time Frame: After 3 months intervention ] [ Designated as safety issue: No ]
    Fasting Plasma Ghrelin concentration

  • GLP-1 [ Time Frame: After 3 months intervention ] [ Designated as safety issue: No ]
    Fasting Plasma GLP-1 concentration

  • insulin [ Time Frame: After 3 months intervention ] [ Designated as safety issue: No ]
    Fasting serum Insulin concentration

  • IL-6 [ Time Frame: After 3 months intervention ] [ Designated as safety issue: No ]
    Serum IL-6 concentration

  • TNF alpha [ Time Frame: After 3 months intervention ] [ Designated as safety issue: No ]
    Serum TNF-Alpha concentration


Enrollment: 36
Study Start Date: May 2011
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350843

Locations
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
Investigators
Principal Investigator: Ian A Macdonald, PhD Nottingham University
  More Information

Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01350843     History of Changes
Other Study ID Numbers: RIS 100058b
Study First Received: May 9, 2011
Last Updated: August 20, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
Men
Orange Juice
Cholesterol
Obesity

Additional relevant MeSH terms:
Dyslipidemias
Insulin Resistance
Obesity
Body Weight
Glucose Metabolism Disorders
Hyperinsulinism
Lipid Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014