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
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