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Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers

Insulin Resistance Clinical Trial

Official title:
Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers: A Controlled Randomized Crossover Trial

Clinical Trial Summary

This study aims to investigate the early metabolic effects and acute phase response of an oral clear supplement containing whey protein plus carbohydrates in young healthy volunteers during fasting-induced organic response

Clinical Trial Description

The investigators will enroll young male healthy volunteers. In this controlled crossover clinical trial, after a 12-hour fast, subjects will be randomized to consumed either: a) 200ml of carbohydrates enriched with whey protein (CHO+WP; n=30); or b) 200ml of water plus maltodextrin (CHO group, n=30); or c) remained fasting (Fast group; n=30). Blood samples will be collected after 12h-fast and three hours after the ingestion of the supplements (or 3h fast in Fast group) for blood glucose; glycated hemoglobin; serum insulin; C-reactive protein; beta-hydroxybutyrate; triglycerides; albumin; chlorine and sodium assays. After a temporal break of seven days an inversion of the groups will performed so all subjects entered in the three groups. Group CHO+P will drink a clear non-residual supplement (698 mOsm/L) having 100% whey protein isolated from total proteins, with various vitamins (B1, B6, C, D, niacin and folic acid) with a "lemon tea" flavor (Nutren Fresh; Nestlé, São Paulo, Brazil). The formula contains no lactose or lipids; is formulated with a volume of 200ml, with a caloric density of 1.28kcal/ml; protein: 10g in 200ml of the product (100% whey protein isolate); and carbohydrate: 54g in 200ml of the product (74% glucose syrup and 26% maltodextrin); Group CHO will received a clear supplement containing 200 mL of water combined with unflavored 25 g of 100% maltodextrin (CarboCH - Prodiet, Curitiba, Brazil) at 12.5% dilution (101 mOsm/kg; 95kcal/200ml). The third group (Fast group; n=10) will not consume any food or supplement. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05656339
Study type Interventional
Source Federal University of Mato Grosso
Contact Jose Nascimento, MD, PhD
Phone +5565999815388
Email jose.aguilar@univag.edu.br
Status Recruiting
Phase N/A
Start date November 1, 2022
Completion date January 30, 2023
View Details
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