Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

December 2, 2014 updated by: Tahitian Noni International, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 10430
        • Department of Nutrition, Faculty of Medicine, University of Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tahitian Noni International, Inc.

Collaborators

Indonesia University

Investigators

  • Principal Investigator: Samuel Oetoro, dr MS SpGK, Indonesia University
  • Study Director: Claude J Jensen, MS, Morinda Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (ESTIMATE)

May 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111118-SUS-NON-AGE-GP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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