The Effects of Orange Juice on Plasma Lipids

NCT01350843 | Completed

• 1 other identifier: RIS 100058b
• 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 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.

Conditions

Insulin Resistance; Obesity; Dyslipidemia

Keywords

Men; Orange Juice; Cholesterol; Obesity

Outcome Measures

Primary Outcomes (1)

• Total Serum Cholesterol concentration

  Fasting Serum total cholesterol concentration (mmol/l)

  after 3 months' intervention

Secondary Outcomes (11)

• High Density Cholesterol (HDL)

  after 3 months' intervention

• Low density cholesterol

  after 3 months' intervention

• Gene expression in adipose tissue

  after 3 months' intervention

• leptin

  after 3 month intervention

• IL-1

  afetr 3 month intervention

Study Arms (2)

Orange Juice

EXPERIMENTAL

Juice high in flavonoids

Dietary Supplement: Orange Juice

Orange Drink

PLACEBO COMPARATOR

Sugars matched, low flavonoids orange drink

Dietary Supplement: Orange Juice

Interventions

Orange Juice DIETARY_SUPPLEMENT

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

Orange Drink; Orange Juice

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

David Greenfield Human Physiology Unit, University of Nottingham

Nottingham, Notts, NG72UH, United Kingdom

Location

Related Publications (4)

• 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

• Simpson EJ, Mendis B, Macdonald IA. Orange juice consumption and its effect on blood lipid profile and indices of the metabolic syndrome; a randomised, controlled trial in an at-risk population. Food Funct. 2016 Apr;7(4):1884-91. doi: 10.1039/c6fo00039h.

  PMID: 26965492 RESULT

MeSH Terms

Conditions

Insulin Resistance; Obesity; Dyslipidemias; Multiple Endocrine Neoplasia Type 1

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; Lipid Metabolism Disorders; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Ian A Macdonald, PhD

  Nottingham University

  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: May 9, 2011
• First Posted: May 10, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)