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Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

Primary Purpose

Oxidative Stress, Quality of Life, Metabolic Syndrome

Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
iridoid enriched mixed fruit beverage
Sponsored by
Tahitian Noni International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oxidative Stress focused on measuring Morinda citrifolia, noni, advanced glycation end products, oxidative stress, quality of life, metabolic syndrome, safety

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

60-240 mL/day

Arm Description

60 -240 mL/day dose group

Outcomes

Primary Outcome Measures

skin autofluorescence (akin advanced glycation end products)
skin autofluorescence with AGE reader

Secondary Outcome Measures

Full Information

First Posted
May 9, 2012
Last Updated
December 2, 2014
Sponsor
Tahitian Noni International, Inc.
Collaborators
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT01597076
Brief Title
Effect of an Iridoid Enriched Beverage on Skin Autofluorescence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tahitian Noni International, Inc.
Collaborators
Indonesia University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Quality of Life, Metabolic Syndrome
Keywords
Morinda citrifolia, noni, advanced glycation end products, oxidative stress, quality of life, metabolic syndrome, safety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
60-240 mL/day
Arm Type
Experimental
Arm Description
60 -240 mL/day dose group
Intervention Type
Dietary Supplement
Intervention Name(s)
iridoid enriched mixed fruit beverage
Other Intervention Name(s)
TruAge Max
Intervention Description
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
Primary Outcome Measure Information:
Title
skin autofluorescence (akin advanced glycation end products)
Description
skin autofluorescence with AGE reader
Time Frame
Baseline and week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Oetoro, dr MS SpGK
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claude J Jensen, MS
Organizational Affiliation
Morinda Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Department of Nutrition, Faculty of Medicine, University of Indonesia
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

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Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

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