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Insulin ResistanceNCT01350843

The Effects of Orange Juice on Plasma Lipids

A study testing Orange Juice in people with Insulin Resistance and Obesity, run by University of Nottingham at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Insulin Resistance, Obesity, Dyslipidemia
What is being tested?
Orange Juice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteUnited Kingdom
Study dates
May 2011to Feb 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • David Greenfield Human Physiology Unit, University of Nottingham

    Nottingham, Notts, NG72UH

Other trials in United Kingdom

About this study

Official title: An Investigation Into the Effects of Orange Juice on Plasma Lipids - an Extension to J/06/2010

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.

Read the 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.

Being tested
Orange Juice
Keywords
Men, Orange Juice, Cholesterol, Obesity
Medical subject headings
Insulin Resistance, Obesity, Dyslipidemias, Multiple Endocrine Neoplasia Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orange JuiceDietary supplement

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

Study groups in NCT01350843
Study groupRoleWhat they receive
Orange JuiceExperimentalJuice high in flavonoids
Receives: Dietary Supplement: Orange Juice
Orange DrinkPlacebo comparatorSugars matched, low flavonoids orange drink
Receives: Dietary Supplement: Orange Juice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Serum Cholesterol concentration

    Fasting Serum total cholesterol concentration (mmol/l)

    Measured: after 3 months' intervention

Secondary outcomes (11)

  1. High Density Cholesterol (HDL)

    Fasting Serum HDL concentration

    Measured: after 3 months' intervention

  2. Low density cholesterol

    Fasting Serum LDL concentration

    Measured: after 3 months' intervention

  3. Gene expression in adipose tissue

    Expression of genes related to lipid metabolism in adipose tissue

    Measured: after 3 months' intervention

  4. leptin

    fasting Serum Leptin concentration

    Measured: after 3 month intervention

  5. IL-1

    Serum IL-1 concentration

    Measured: afetr 3 month intervention

  6. Blood Pressure

    Resting blood pressure, measured semi-supine

    Measured: after 3months intervention

  7. Ghrelin

    Fasting Plasma Ghrelin concentration

    Measured: After 3 months intervention

  8. GLP-1

    Fasting Plasma GLP-1 concentration

    Measured: After 3 months intervention

  9. insulin

    Fasting serum Insulin concentration

    Measured: After 3 months intervention

  10. IL-6

    Serum IL-6 concentration

    Measured: After 3 months intervention

  11. TNF alpha

    Serum TNF-Alpha concentration

    Measured: After 3 months intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2012
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01350843
Sponsor's protocol ID
RIS 100058b
Status last verified
Mar 2018
First submitted
9 May 2011
Last updated
27 Mar 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 18390796

  • 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.

    PubMed 16579728

  • 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.

  • 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.

    PubMed 26965492

Questions about this trial

What is this clinical trial studying?

A study testing Orange Juice in people with Insulin Resistance and Obesity, run by University of Nottingham at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Serum Cholesterol concentration (time frame: after 3 months' intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01350843, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.

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