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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738763
• Other study ID #: WIL-PIN-2011-01
• Status: Completed
• Phase: N/A
• First received: November 20, 2012
• Last updated: November 27, 2012
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2012
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Insulin Sensitivity

Intervention

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.

Locations

Country	Name	City	State
Spain	University Hospital Dr Peset	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	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	Yes