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Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

T

Tahitian Noni International

Status and phase

Completed
Phase 1

Conditions

Quality of Life
Oxidative Stress
Metabolic Syndrome

Treatments

Dietary Supplement: iridoid enriched mixed fruit beverage

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01597076
111118-SUS-NON-AGE-GP

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

25 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

34 participants in 1 patient group

60-240 mL/day
Experimental group
Description:
60 -240 mL/day dose group
Treatment:
Dietary Supplement: iridoid enriched mixed fruit beverage

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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