Dose-response Effect of a Noni Juice Mixed Fruit Beverage
This study is ongoing, but not recruiting participants.
Sponsor:
Tahitian Noni International, Inc.
Collaborators:
Sprim Advanced Life Sciences
University of Indonesia
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
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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
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
University of Indonesia
Investigators
| Principal Investigator: | Samuel Oetoro, dr MS SpGK | University of Indonesia |
| 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 Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013