Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

Phase 1

Completed

• Conditions: Oxidative Stress; Metabolic Syndrome; Quality of Life
• Interventions: Dietary Supplement: iridoid enriched mixed fruit beverage

• Registration Number: NCT01597076
• Lead Sponsor: Tahitian Noni International, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-11
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
60-240 mL/day	iridoid enriched mixed fruit beverage	60 -240 mL/day dose group

Primary Outcome Measures

Name	Time	Method
skin autofluorescence (akin advanced glycation end products)	Baseline and week 8	skin autofluorescence with AGE reader

Trial Locations

Locations (1)

Department of Nutrition, Faculty of Medicine, University of Indonesia; 🇮🇩 Jakarta, Indonesia