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Completed

NCT Number: NCT01597076

Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

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.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Nutrition, Faculty of Medicine, University of Indonesia

Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: TruAge Max

Primary outcomes

  1. skin autofluorescence (akin advanced glycation end products)

    Time frame: Baseline and week 8

    skin autofluorescence with AGE reader

Sponsors and collaborators

Lead sponsor

Tahitian Noni International, Inc.

Industry

Collaborators

  • Indonesia University

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 11, 2012
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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