- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01201603
The Effects of Orange Juice on Insulin Sensitivity and Plasma Lipids
Study Overview
Status
Conditions
Intervention / Treatment
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. 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 insulin sensitivity, 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 women (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 and to consume a diet providing 50% of energy as carbohydrate for 3 days prior to the 2nd laboratory visit. This 2nd visit will involve having a DEXA body composition scan, an adipose tissue biopsy and a 3-hr hyperinsulinemic, euglycemic glucose clamp. 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. A standardized diet will be consumed for 3 days prior to the final laboratory visit, as before. This 5th visit will be identical to visit 2.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Notts
-
Nottingham, Notts, United Kingdom, NG7 2UH
- University of Nottingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- pre-menopausal or post-menopausal and taking HRT
- BMI 27-35kg/m2
- HOMA-IR value > 1.5
- healthy
Exclusion Criteria:
- pregnant or breast feeding,
- any metabolic or endocrine abnormalities,
- clinically significant abnormalities on screening,
- fasting glucose > 6.0mmol/l,
- taking medication other than the contraceptive pill or HRT
- herbal supplement use,
- food allergies/intolerances related to the investigational product (citrus juices, fructose)
- daily consumption of >100ml citrus juices
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Orange Juice
Orange Juice reconstituted from frozen concerntrate
|
250ml of orange juice or a sugars matched orange drink
|
PLACEBO_COMPARATOR: Orange drink
Sugars matched orange drink
|
250ml of orange juice or a sugars matched orange drink
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin sensitivity ('M' value)
Time Frame: after 3 months' intervention
|
Insulin sensitivity (mg glucose disposal from the blood/kg body weight/min)calculated from glucose disposal during a hyperinsulinemic, euglycemic glucose clamp
|
after 3 months' intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose Oxidation rate
Time Frame: after 3 months' intervention period
|
Measured by ventilated hood indirect calorimetry
|
after 3 months' intervention period
|
High Density Cholesterol
Time Frame: after 3 months' intervention
|
Serum HDL concentration
|
after 3 months' intervention
|
Low density cholesterol
Time Frame: after 3 months' intervention
|
Serum LDL concentration
|
after 3 months' intervention
|
Gene expression in adipose tissue
Time Frame: after 3 months' intervention
|
Expression of genes related to insulin sensitivity in adipose tissue
|
after 3 months' intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Bazzano LA, Li TY, Joshipura KJ, Hu FB. Intake of fruit, vegetables, and fruit juices and risk of diabetes in women. Diabetes Care. 2008 Jul;31(7):1311-7. doi: 10.2337/dc08-0080. Epub 2008 Apr 4.
- Fujioka K, Greenway F, Sheard J, Ying Y. The effects of grapefruit on weight and insulin resistance: relationship to the metabolic syndrome. J Med Food. 2006 Spring;9(1):49-54. doi: 10.1089/jmf.2006.9.49.
- O'Neil CE, Nicklas TA. A review of the relationship between 100% fruit juice consumption and weight in children and adolescents. American Journal of Lifestyle Medicine 2(4): 315-354, 2008.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIS 100058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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