Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

Study Overview
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Brief Summary
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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.

Conditions
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Oxidative Stress, Quality of Life, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: iridoid enriched mixed fruit beverage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 60-240 mL/day<br>60 -240 mL/day dose group | Dietary Supplement: iridoid enriched mixed fruit beverage<br>* 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<br>* Other names: TruAge Max;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin autofluorescence (akin advanced glycation end products) | skin autofluorescence with AGE reader | Baseline and week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morinda citrifolia, noni, advanced glycation end products, oxidative stress, quality of life, metabolic syndrome, safety