Metabolic syndrome/obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| Oxidative stress via F2 isoprostance in urine. All outcomes measured at baseline, 4 weeks and 8 weeks. | — |
Countries
United States of America