Dose-response Effect of a Noni Juice Mixed Fruit Beverage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Tahitian Noni International, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Sprim Advanced Life Sciences
Indonesia University
Information provided by (Responsible Party):
Tahitian Noni International, Inc.
ClinicalTrials.gov Identifier:
NCT01597076
First received: May 9, 2012
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

The objectives of this clinical trial are to evaluate the dose-response effectiveness of a proprietary fruit-based beverage on oxidative stress, quality of life, and determinants of metabolic syndrome in overweight and obese adults.


Condition Intervention Phase
Oxidative Stress
Quality of Life
Metabolic Syndrome
Dietary Supplement: Noni juice mixed fruit beverage
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Dose-response Effect of a Noni Juice Mixed Fruit Beverage on Oxidative Stress, Quality of Life, and Determinants of Metabolic Syndrome in Overweight and Obese Adults: a Randomized, Controlled, Open Label Study

Resource links provided by NLM:


Further study details as provided by Tahitian Noni International, Inc.:

Primary Outcome Measures:
  • Plasma carboxymethyl-lysine [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
    Plasma carboxymethyl-lysine by ELISA


Secondary Outcome Measures:
  • Urinary carboxymethyl-lysine [ Time Frame: Baselina & week 8 ] [ Designated as safety issue: No ]
    Urinary carboxymethyl-lysine by ELISA


Estimated Enrollment: 48
Study Start Date: May 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 60 mL/day
60 mL/day dose group
Dietary Supplement: Noni juice 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: Thrive Adaptogenics Max
Experimental: 120 mL/day
120 mL/day dose group
Dietary Supplement: Noni juice 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: Thrive Adaptogenics Max
Experimental: 240 mL/day
240 mL/day dose group
Dietary Supplement: Noni juice 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: Thrive Adaptogenics Max
Placebo Comparator: placebo
isocaloric placebo beverage
Dietary Supplement: Noni juice 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: Thrive Adaptogenics Max

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597076

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

No publications provided

Responsible Party: Tahitian Noni International, Inc.
ClinicalTrials.gov Identifier: NCT01597076     History of Changes
Other Study ID Numbers: 111118-SUS-NON-AGE-GP
Study First Received: May 9, 2012
Last Updated: August 24, 2012
Health Authority: Indonesia: Departement Kesehatan (Department of Health)

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
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014