Mangosteen juice blend for the reduction of inflammation in obese subjects

ISRCTN ISRCTN93000276
DOI https://doi.org/10.1186/ISRCTN93000276
Secondary identifying numbers XANG1000
Submission date
21/07/2009
Registration date
19/08/2009
Last edited
19/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jay Udani
Scientific

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

Study information

Study designRandomised double-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleMangosteen juice blend for the reduction of inflammation in obese subjects: a randomised, double-blind, placebo-controlled, dose finding study
Study objectivesThe 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(s)Institutional Review Board (IRB) approval obtained from the Copernicus Group (Cary, NC) on the 11th July 2007 (ref: MED4-07-299)
Health condition(s) or problem(s) studiedMetabolic syndrome/obesity
InterventionThis 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)XanGo™ Juice
Primary outcome measureEfficacy 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 measuresOxidative stress via F2 isoprostance in urine. All outcomes measured at baseline, 4 weeks and 8 weeks.
Overall study start date01/09/2007
Completion date01/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/09/2007
Date of final enrolment01/05/2008

Locations

Countries of recruitment

  • United States of America

Study participating centre

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

Sponsor information

XanGo, LLC (USA)
Industry

3098 Executive Parkway
Lehi, UT
84043
United States of America

Website http://www.xango.com/
ROR logo "ROR" https://ror.org/041mqc477

Funders

Funder type

Industry

XanGo, LLC (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan