Oxidative StressPhase 1NCT01597076
Effect of an Iridoid Enriched Beverage on Skin Autofluorescence
A Phase 1 study testing iridoid enriched mixed fruit beverage in people with Oxidative Stress and Quality of Life, run by Tahitian Noni International, Inc. at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Quality of Life, Metabolic Syndrome
- What is being tested?
- iridoid enriched mixed fruit beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndonesia
- Study dates
- May 2012to Aug 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Nutrition, Faculty of Medicine, University of Indonesia
Jakarta, 10430
About this study
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
- Being tested
- iridoid enriched mixed fruit beverage
- Keywords
- Morinda citrifolia, noni, advanced glycation end products, oxidative stress, quality of life, metabolic syndrome, safety
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iridoid enriched mixed fruit beverageDietary supplement
Also called TruAge Max
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
| Study group | Role | What they receive |
|---|---|---|
| 60-240 mL/day | Experimental | 60 -240 mL/day dose group Receives: Dietary Supplement: iridoid enriched mixed fruit beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin autofluorescence (akin advanced glycation end products)
skin autofluorescence with AGE reader
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tahitian Noni International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitas Indonesia
- Responsible party
- Sponsor
- Investigators
- Samuel Oetoro, dr MS SpGK, Principal investigator, Universitas IndonesiaClaude J Jensen, MS, Study director, Morinda Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597076
- Sponsor's protocol ID
- 111118-SUS-NON-AGE-GP
- Status last verified
- Aug 2012
- First submitted
- 9 May 2012
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Iridoid Enriched Beverage on Skin Autofluorescence
- ClinicalTrials.gov ID
- NCT01597076
- Acronym / sponsor ID
- 111118-SUS-NON-AGE-GP
- Conditions
- Oxidative Stress, Quality of Life, Metabolic Syndrome
- Keywords
- Morinda citrifolia, noni, advanced glycation end products, oxidative stress, quality of life, metabolic syndrome, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Tahitian Noni International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Universitas Indonesia
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 60-240 mL/day | Experimental | Dietary Supplement: iridoid enriched mixed fruit beverage60 -240 mL/day dose group |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iridoid enriched mixed fruit beverageAlso: TruAge MaxMixed 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 | Dietary supplement | 60-240 mL/day |
Primary outcome
skin autofluorescence (akin advanced glycation end products)
Time frame: Baseline and week 8
skin autofluorescence with AGE reader
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
Related trials for Oxidative Stress
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Gaucher Disease Type I, Oxidative Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Oetoro, dr MS SpGK principal investigator
Universitas Indonesia
Claude J Jensen, MS study director
Morinda Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing iridoid enriched mixed fruit beverage in people with Oxidative Stress and Quality of Life, run by Tahitian Noni International, Inc. at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin autofluorescence (akin advanced glycation end products) (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.