The Effects of Orange Juice on Insulin Sensitivity and Plasma Lipids

NCT01201603 | Completed

• 1 other identifier: RIS 100058
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is primarily to investigate the ability of antioxidants found in orange juice (OJ) to increase the body's sensitivity to the hormone insulin. Overweight or mildly obese women, who are otherwise healthy, 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 \~5hrs 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, and have their insulin sensitivity measured using a technique called a 'Glucose Clamp'. During the 3hr glucose clamp, subjects receive an infusion of the hormone insulin and a glucose solution directly into their blood stream, with insulin sensitivity determined from the amount of glucose required to maintain blood glucose at normal levels. In addition, a small sample of fat tissue (about the size of a haricot bean) will be 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.

Conditions

Insulin Resistance; Obesity

Keywords

Women; Orange Juice; Insulin Resistance; Obesity

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity ('M' value)

  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 Outcomes (4)

• Glucose Oxidation rate

  after 3 months' intervention period

• High Density Cholesterol

  after 3 months' intervention

• Low density cholesterol

  after 3 months' intervention

• Gene expression in adipose tissue

  after 3 months' intervention

Study Arms (2)

Orange Juice

EXPERIMENTAL

Orange Juice reconstituted from frozen concerntrate

Dietary Supplement: orange juice

Orange drink

PLACEBO COMPARATOR

Sugars matched orange drink

Dietary Supplement: orange juice

Interventions

orange juice DIETARY_SUPPLEMENT

250ml of orange juice or a sugars matched orange drink

Orange Juice; Orange drink

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• pre-menopausal or post-menopausal and taking HRT
• BMI 27-35kg/m2
• HOMA-IR value \> 1.5
• healthy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Florida Department of Citrus: collaborator

Study Sites (1)

University of Nottingham

Nottingham, Notts, NG7 2UH, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 18390796 BACKGROUND

• 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.

  PMID: 16579728 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Insulin Resistance; Obesity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian A Macdonald, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 14, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: November 1, 2013
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)