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

November 27, 2012 updated by: Antonio Hernández Mijares, University of Valencia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46017
        • University Hospital Dr Peset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose (2.5 g of pinitol)
Each subject completed two 1-day trials separated by a 1-week interval. The subjects were randomized by alternation method to belong to the group of low, intermediate or high dose, containing 2.5, 4.0 or 6.0 g of pinitol, respectively. Each subject was newly randomized (1:1) and cross-over into one of two groups: one that received the pinitol-enriched beverage, and the other a placebo beverage. In this way, each dose and its corresponding placebo were studied in 10 normoglycaemic subjects.
Dietary supplement: Pinitol
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
Experimental: Intermediate dose (4.0 g of pinitol)
Each subject completed two 1-day trials separated by a 1-week interval. The subjects were randomized by alternation method to belong to the group of low, intermediate or high dose, containing 2.5, 4.0 or 6.0 g of pinitol, respectively. Each subject was newly randomized (1:1) and cross-over into one of two groups: one that received the pinitol-enriched beverage, and the other a placebo beverage. In this way, each dose and its corresponding placebo were studied in 10 normoglycaemic subjects.
Dietary supplement: Pinitol
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
Experimental: High dose (6.0 g of pinitol)
Each subject completed two 1-day trials separated by a 1-week interval. The subjects were randomized by alternation method to belong to the group of low, intermediate or high dose, containing 2.5, 4.0 or 6.0 g of pinitol, respectively. Each subject was newly randomized (1:1) and cross-over into one of two groups: one that received the pinitol-enriched beverage, and the other a placebo beverage. In this way, each dose and its corresponding placebo were studied in 10 normoglycaemic subjects.
Dietary supplement: Pinitol
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: Antonio Hernández Mijares, MD, PhD, University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 20, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIL-PIN-2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Pinitol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe