Metabolic Syndrome, Oxidative Stress, Quality of Life
Conditions
Keywords
Morinda citrifolia, noni, advanced glycation end products, oxidative stress, quality of life, metabolic syndrome, safety
Brief summary
The objectives of this clinical trial are to evaluate the effectiveness of an iridoid enriched beverage containing noni and cornelian juices and olive leaf extract on advanced glycation end product levels.
Interventions
DIETARY_SUPPLEMENTiridoid enriched mixed fruit beverage
Mixed fruit beverage consisting of noni (Morinda citrifolia) juice, Cornelian cherry (Cornus mas & Cornus officinalis) puree and juice, olive (Olea europea) leaf extract, and other fruit juices and natural flavors
Sponsors
Indonesia University
Tahitian Noni International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females age 25 to 60 years. * Overweight or obese, defined as BMI 23.0 to 39.9 kg/m2. * Impaired fasting glucose, defined as fasting blood glucose 100 to 125 mg/dl. * Prehypertension or Grade 1 hypertension, defined as systolic blood pressure 120-159 mm Hg AND diastolic BP 80-99 mm Hg. * Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects. * Consent to the study and willing to comply with study procedures.
Exclusion criteria
* Prescription medication use for hypertension, high cholesterol, diabetes, heart disease, cancer, liver disease, or AIDS/HIV 2. * Intake of foods and/or dietary supplements that may confound study outcomes including any use of a noni-based dietary supplement in the last month. * Regular use (\> 3 times per week over the past month) of any dietary supplement that contains super fruits or high antioxidant concentrations. * Regular use (\> 3 times per week over the past month) of any dietary supplement intended to alter or regulate blood glucose levels. * Any medical conditions or diseases that may affect subject safety or confound study results (in the opinion of the investigator). * Pregnant or lactating female. * History of alcohol, drug, or medication abuse. * Current heavy smokers (1 or more packs/day). * Allergies to any ingredient in the investigational products. * Participation in another study with any investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| skin autofluorescence (akin advanced glycation end products) | Baseline and week 8 | skin autofluorescence with AGE reader |
Countries
Indonesia
Outcome results
None listed