Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/07/2009
Date assigned
19/08/2009
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jay Udani

ORCID ID

Contact details

18250 Roscoe Blvd. Suite 240
Northridge
91325
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

XANG1000

Study information

Scientific title

Mangosteen juice blend for the reduction of inflammation in obese subjects: a randomised, double-blind, placebo-controlled, dose finding study

Acronym

Study hypothesis

The hypothesis of this study is that XanGo™ Juice (a proprietary juice blend containing mangosteen juice) will reduce inflammation and increase antioxidant levels in obese subjects.

Ethics approval

Institutional Review Board (IRB) approval obtained from the Copernicus Group (Cary, NC) on the 11th July 2007 (ref: MED4-07-299)

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Metabolic syndrome/obesity

Intervention

This is a randomised, double-blind, placebo-controlled 8-week study with a 2-week pre-study washout period. The study included four groups including placebo and three doses of test product. The study was conducted at a single site Medicus Research clinical research center, Northridge, CA, USA.

The test product was XanGo™ Juice produced by XanGo, LLC. The primary ingredient was mangosteen (Garcinia mangostana L.) whole fruit puree. Other ingredients were apple fruit juice, pear fruit juice, grape fruit juice, pear fruit puree, blueberry fruit juice, raspberry fruit juice, strawberry fruit juice, cranberry fruit juice, and cherry fruit juice. The placebo consisted of water, sucrose (3 g/30 ml), citric acid, red grape juice concentrate, fibre complex, grape skin, natural flavours, red #40, cloud (ester gum), whey protein isolate, sodium benzoate, xanthan gum, blue #1, and caramel color. Three different dosages of the juice were tested and compared to placebo. The product doses tested were 3 oz, 6 oz and 9 oz. All doses and placebo were consumed in a total of 9 oz of liquid in identical bottles. The placebo was used to make up the volume for the lower doses. Subjects were instructed to consume the assigned drink twice a day, once in the morning and again in the evening. They therefore took a total of 0 to 18 oz of active product per day in 18 oz of fluid for 8 weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

XanGo™ Juice

Primary outcome measures

Efficacy of multiple doses of XanGo™ Juice compared to placebo on inflammation as measured by levels of HS-CRP and cytokines (interleukin [IL]-1, IL-2, IL-4, IL-6, IL-7, IL-8, IL-10, IL-12, interferon (IFN)-gamma and tumour necrosis factor (TNF)-alpha). All outcomes measured at baseline, 4 weeks and 8 weeks.

Secondary outcome measures

Oxidative stress via F2 isoprostance in urine. All outcomes measured at baseline, 4 weeks and 8 weeks.

Overall trial start date

01/09/2007

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 30 - 75 years of age, either sex
2. Body mass index (BMI) greater than 30 and less than 45 kg/m^2 (obese)
3. A high sensitivity C-reactive protein (HS-CRP) of greater than 3
4. Agreed to discontinue anti-inflammatory medications and supplements (other than daily 81 mg aspirin, which was allowed)
5. Agreed to use approved birth control methods if a female of childbearing age
6. Agreed to not initiate or change any exercise or diet programs during the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Subjects were excluded if they had consumed the test product in the past
2. Had allergies to the test product
3. Using any drugs that can affect CRP
4. Were taking hormone replacements, anticoagulants or anti-platelet therapy
5. Had surgery in the past 6 months
6. Smoked cigarettes
7. Known alcohol or drug abuse
8. Had major systemic, inflammatory or chronic disease
9. Untreated depression
10. Active eating disorder
11. Unable to understand or follow study protocol
12. Pregnant or lactating
13. Any medical condition which, in the opinion of the investigator, might interfere with the subject's ability in the trial

Recruitment start date

01/09/2007

Recruitment end date

01/05/2008

Locations

Countries of recruitment

United States of America

Trial participating centre

18250 Roscoe Blvd. Suite 240
Northridge
91325
United States of America

Sponsor information

Organisation

XanGo, LLC (USA)

Sponsor details

3098 Executive Parkway
Lehi
UT
84043
United States of America

Sponsor type

Industry

Website

http://www.xango.com/

Funders

Funder type

Industry

Funder name

XanGo, LLC (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes