Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

Quality of Life Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597076
• Other study ID #: 111118-SUS-NON-AGE-GP
• Status: Completed
• Phase: Phase 1
• First received: May 9, 2012
• Last updated: December 2, 2014
• Start date: May 2012
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Tahitian Noni International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Oxidative Stress
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
Indonesia	Department of Nutrition, Faculty of Medicine, University of Indonesia	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Tahitian Noni International, Inc.	Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin autofluorescence (akin advanced glycation end products)	skin autofluorescence with AGE reader	Baseline and week 8	No