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

NCT01738763 | Completed

• 1 other identifier: WIL-PIN-2011-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Insulin Sensitivity

Keywords

Glucose; Insulin; 3-O-methyl-D-chiro-inositol

Outcome Measures

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

  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 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

  up to 240 minutes

Study Arms (3)

Low dose (2.5 g of pinitol)

EXPERIMENTAL

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

Intermediate dose (4.0 g of pinitol)

EXPERIMENTAL

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

High dose (6.0 g of pinitol)

EXPERIMENTAL

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

Interventions

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.

Also known as: 3-O-methyl-D-chiro-inositol

High dose (6.0 g of pinitol); Intermediate dose (4.0 g of pinitol); Low dose (2.5 g of pinitol)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University Hospital Dr Peset

Valencia, 46017, Spain

Location

Related Publications (7)

• Stull AJ, Wood KV, Thyfault JP, Campbell WW. Effects of acute pinitol supplementation on plasma pinitol concentration, whole body glucose tolerance, and activation of the skeletal muscle insulin receptor in older humans. Horm Metab Res. 2009 May;41(5):381-6. doi: 10.1055/s-0028-1128140. Epub 2009 Feb 16.

  PMID: 19221977 BACKGROUND

• Campbell WW, Haub MD, Fluckey JD, Ostlund RE Jr, Thyfault JP, Morse-Carrithers H, Hulver MW, Birge ZK. Pinitol supplementation does not affect insulin-mediated glucose metabolism and muscle insulin receptor content and phosphorylation in older humans. J Nutr. 2004 Nov;134(11):2998-3003. doi: 10.1093/jn/134.11.2998.

  PMID: 15514265 BACKGROUND

• Larner J, Allan G, Kessler C, Reamer P, Gunn R, Huang LC. Phosphoinositol glycan derived mediators and insulin resistance. Prospects for diagnosis and therapy. J Basic Clin Physiol Pharmacol. 1998;9(2-4):127-37. doi: 10.1515/jbcpp.1998.9.2-4.127.

  PMID: 10212830 BACKGROUND

• Larner J, Brautigan DL, Thorner MO. D-chiro-inositol glycans in insulin signaling and insulin resistance. Mol Med. 2010 Nov-Dec;16(11-12):543-52. doi: 10.2119/molmed.2010.00107. Epub 2010 Aug 27.

  PMID: 20811656 BACKGROUND

• Kang MJ, Kim JI, Yoon SY, Kim JC, Cha IJ. Pinitol from soybeans reduces postprandial blood glucose in patients with type 2 diabetes mellitus. J Med Food. 2006 Summer;9(2):182-6. doi: 10.1089/jmf.2006.9.182.

  PMID: 16822203 BACKGROUND

• Kim JI, Kim JC, Kang MJ, Lee MS, Kim JJ, Cha IJ. Effects of pinitol isolated from soybeans on glycaemic control and cardiovascular risk factors in Korean patients with type II diabetes mellitus: a randomized controlled study. Eur J Clin Nutr. 2005 Mar;59(3):456-8. doi: 10.1038/sj.ejcn.1602081.

  PMID: 15536472 BACKGROUND

• Kim HJ, Park KS, Lee SK, Min KW, Han KA, Kim YK, Ku BJ. Effects of pinitol on glycemic control, insulin resistance and adipocytokine levels in patients with type 2 diabetes mellitus. Ann Nutr Metab. 2012;60(1):1-5. doi: 10.1159/000334834. Epub 2011 Dec 16.

  PMID: 22179130 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Interventions

pinitol

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Antonio Hernández Mijares, MD, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 30, 2012
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: November 30, 2012

Record last verified: 2012-11

Locations

ES (1)