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Mangosteen juice blend for the reduction of inflammation in obese subjects

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN93000276
Enrollment
40
Registered
2009-08-19
Start date
2007-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome/obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

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

Sponsors

XanGo, LLC (USA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026