Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers

Not Applicable

Recruiting

• Conditions: Insulin Resistance; Ketosis; Acute-Phase Response
• Interventions: Dietary Supplement: CHO; Dietary Supplement: Fast; Dietary Supplement: CHO+WP

• Registration Number: NCT05656339
• Lead Sponsor: Federal University of Mato Grosso

Brief 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

Detailed 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 Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2022-11-22
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-09
• Last Update Submitted: 2022-12-09
• Study First Posted: 2022-12-19
• Last Update Posted: 2022-12-19
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Male young healthy volunteers

Exclusion Criteria

or will be excluded.

• Individuals with obesity (calculated body mass index above 30 kg/m2)
• Participants reporting consumption of alcoholic beverages
• Consumption of any nutritional supplement during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Carbohydrate supplement - CHO group	CHO	After 12 hours fast participants will collect blood samples and immediately will drink an oral supplement containing carbohydrates alone without whey protein. After 3 hours of ingesting the supplement blood samples will be collected again
12 hours Fast - Fast Group	Fast	Participants will proceed in 12 hours fast condition for blood collection for laboratory assays
Carbohydrate plus whey protein supplement - CHO+WP group	CHO+WP	After 12 hours fast participants will collect blood samples and immediately will drink an oral supplement containing carbohydrates plus whey protein. After 3 hours of ingesting the supplement blood samples will be collected again

Primary Outcome Measures

Name	Time	Method
Change in serum hydroxy butyrate	Change from 12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement	Serum hydroxy butyrate levels from 12 hours fast at 3 hours after ingestion of oral supplement
Change in acute phase response proteins	Change from12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement	Change of serum C reactive protein and albumin from 12 hours fast (baseline) to 3 hours after ingestion of the oral supplement
Change in insulin resistance	Change from12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement	Change of HOMA index from 12 hours fast (baseline) to 3 hours after ingestion of the oral supplement

Trial Locations

Locations (1)

Centro Universitário de Varzea Grande (UNIVAG); 🇧🇷 Varzea Grande, Mato Grosso, Brazil