Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

NCT01597076 | Completed Phase 1 DMC

• 1 other identifier: 111118-SUS-NON-AGE-GP
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress; Quality of Life; Metabolic Syndrome

Keywords

Morinda citrifolia; noni; advanced glycation end products; oxidative stress; quality of life; metabolic syndrome; safety

Outcome Measures

Primary Outcomes (1)

• skin autofluorescence (akin advanced glycation end products)

  skin autofluorescence with AGE reader

  Baseline and week 8

Study Arms (1)

60-240 mL/day

EXPERIMENTAL

60 -240 mL/day dose group

Dietary Supplement: iridoid enriched mixed fruit beverage

Interventions

iridoid enriched mixed fruit beverage DIETARY_SUPPLEMENT

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

Also known as: TruAge Max

60-240 mL/day

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tahitian Noni International, Inc.: lead
• Indonesia University: collaborator

Study Sites (1)

Department of Nutrition, Faculty of Medicine, University of Indonesia

Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Samuel Oetoro, dr MS SpGK

  Indonesia University

  PRINCIPAL INVESTIGATOR

• Claude J Jensen, MS

  Morinda Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 11, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 4, 2014

Record last verified: 2012-08

Locations

ID (1)