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

University of Valencia

Status: Completed

Conditions: Healthy; Insulin Sensitivity

Treatments: Dietary Supplement: Pinitol

Study type: Interventional

Funder types: Other

Identifiers

NCT01738763

WIL-PIN-2011-01

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Low dose (2.5 g of pinitol)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Pinitol

Intermediate dose (4.0 g of pinitol)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Pinitol

High dose (6.0 g of pinitol)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Pinitol