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Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

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ClinicalTrials.gov Identifier: NCT01597076
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : December 4, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : May 2012
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: TruAge Max


Outcome Measures

Primary Outcome Measures :
  1. skin autofluorescence (akin advanced glycation end products) [ Time Frame: Baseline and week 8 ]
    skin autofluorescence with AGE reader


Eligibility Criteria

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597076


Locations
Indonesia
Department of Nutrition, Faculty of Medicine, University of Indonesia
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Tahitian Noni International, Inc.
Indonesia University
Investigators
Principal Investigator: Samuel Oetoro, dr MS SpGK Indonesia University
Study Director: Claude J Jensen, MS Morinda Inc.
More Information

Responsible Party: Tahitian Noni International, Inc.
ClinicalTrials.gov Identifier: NCT01597076     History of Changes
Other Study ID Numbers: 111118-SUS-NON-AGE-GP
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: August 2012

Keywords provided by Tahitian Noni International, Inc.:
Morinda citrifolia
noni
advanced glycation end products
oxidative stress
quality of life
metabolic syndrome
safety

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases