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
Scientific
18250 Roscoe Blvd. Suite 240
Northridge
91325
United States of America
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Mangosteen juice blend for the reduction of inflammation in obese subjects: a randomised, double-blind, placebo-controlled, dose finding study |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | XanGo™ Juice |
| Primary outcome measure | 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 study start date | 01/09/2007 |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- United States of America
Study participating centre
18250 Roscoe Blvd. Suite 240
Northridge
91325
United States of America
91325
United States of America
Sponsor information
XanGo, LLC (USA)
Industry
Industry
3098 Executive Parkway
Lehi, UT
84043
United States of America
| Website | http://www.xango.com/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
