Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

Sponsor

Tahitian Noni International, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01597076

Collaborator

Indonesia University (Other)

Enrollment

Location

Arm

Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress Quality of Life Metabolic Syndrome	Dietary Supplement: iridoid enriched mixed fruit beverage	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 60-240 mL/day 60 -240 mL/day dose group	Dietary Supplement: iridoid 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 Other Names: TruAge Max

Arm

Intervention/Treatment

Experimental: 60-240 mL/day

60 -240 mL/day dose group

Dietary Supplement: iridoid 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

Other Names:

TruAge Max

Outcome Measures

Primary Outcome Measures

skin autofluorescence (akin advanced glycation end products) [Baseline and week 8]
skin autofluorescence with AGE reader

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.