Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

NCT ID: NCT01597076

Last Updated: 2014-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

60-240 mL/day

60 -240 mL/day dose group

Group Type: EXPERIMENTAL

iridoid enriched mixed fruit beverage

Intervention Type: 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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

TruAge Max

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: collaborator

Tahitian Noni International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Oetoro, dr MS SpGK

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Claude J Jensen, MS

Role: STUDY_DIRECTOR

Morinda Inc.

Locations

Department of Nutrition, Faculty of Medicine, University of Indonesia

Jakarta, , Indonesia

Countries

Indonesia

Other Identifiers

111118-SUS-NON-AGE-GP

Identifier Type: -

Identifier Source: org_study_id