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Completed

NCT Number: NCT01738763

Effects of Different Doses of Pinitol on Carbohydrate Metabolism Parameters in Healthy Subjects

The purpose of this study was to assess the acute effects of increasing doses of pinitol on glucose tolerance and insulin sensitivity and to evaluate the absorption of pinitol after consumption of an oral nutritive pinitol-enriched beverage in healthy subjects.

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Key information

Conditions

Healthy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Dr Peset

Valencia, 46017, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The inclusion criteria for all subjects were age range of 18-65 years, body mass index of 20-30 Kg/m2 and clinically normal kidney function, liver function, heart function, protein status and haematological profile.

Exclusion criteria

  • Exclusion criteria were pregnancy or lactation, alteration of carbohydrate metabolism, fasting glycaemia ≥5.55 mmol/l on at least two previous occasions, diabetes, or medication known to interfere with glucose metabolism.

Treatment and study plan

Pinitol

Dietary Supplement

Three doses of Fruit Up® (diluted with mineral water to a final volume of 330 ml) were evaluated, and were equivalent to an intake of 2.5, 4.0 and 6.0 g of pinitol. The placebo beverage contained equal amounts of non-polyol carbohydrates with similar macronutrient composition and energy intake as that those obtained through the pinitol beverage, but excluding pinitol.

Other names: 3-O-methyl-D-chiro-inositol

Primary outcomes

  1. Dose-response curves to assess the change in glucose and insulin concentration after an oral ingestion of different doses of pinitol with respect to the corresponding placebo

    Time frame: up to 120 minutes

    Each subject attended the Endocrinology Service in the morning after 12-hour overnight fasting. Blood sample was collected in vacutainer serum separator tubes at baseline (minute 0; while still fasting), 15, 30, 45, 60, 90 and 120 minutes after consumption of the tested product placebo or pinitol-enriched beverage. Glucose concentrations were measured by means of enzymatic assay in an autoanalyzer. Insulin concentrations were determined by enzyme-linked immunosorbent assay.

Secondary outcomes

  1. Dose-response curves to assess the change in pinitol concentration after an oral ingestion of different doses of pinitol with respect to the corresponding placebo

    Time frame: up to 240 minutes

    Plasma pinitol analysis blood samples were collected into vacutainers containing lithium heparin at baseline, 60, 120, 180 and 240 minutes after consumption of the tested product placebo or pinitol-enriched beverage. Pinitol concentration was determined by gas chromatography/ mass spectrometry

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Effects of Different Doses of Pinitol on Carbohydrate Metabolism Parameters in Healthy Subjects: a Randomized Cross-over Placebo-controlled Study

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Nov 30, 2012
Registry last updated
Nov 30, 2012

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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