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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antonio Hernández Mijares, University of Valencia
ClinicalTrials.gov Identifier:
NCT01738763
First received: November 20, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Healthy
Insulin Sensitivity
Dietary Supplement: Pinitol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effects of Different Doses of Pinitol on Carbohydrate Metabolism Parameters in Healthy Subjects: a Randomized Cross-over Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by University of Valencia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 30
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 3-O-methyl-D-chiro-inositol

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738763

Locations
Spain
University Hospital Dr Peset
Valencia, Spain, 46017
Sponsors and Collaborators
University of Valencia
Investigators
Principal Investigator: Antonio Hernández Mijares, MD, PhD University of Valencia
  More Information

Publications:
Responsible Party: Antonio Hernández Mijares, PhD, MD, University of Valencia
ClinicalTrials.gov Identifier: NCT01738763     History of Changes
Other Study ID Numbers: WIL-PIN-2011-01
Study First Received: November 20, 2012
Last Updated: November 27, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by University of Valencia:
Glucose
Insulin
3-O-methyl-D-chiro-inositol

Additional relevant MeSH terms:
Inositol
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 20, 2014