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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05656339
• Other study ID #: 42481121.3.0000.5692
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: December 2022
• Source: Federal University of Mato Grosso
• Contact: Jose Nascimento, MD, PhD
• Phone: +5565999815388
• Email: jose.aguilar[@]univag.edu.br
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-Phase Reaction
• Acute-Phase Response
• Insulin Resistance
• Ketosis

Intervention

Dietary Supplement:
• CHO+WP
Oral supplement containing carbohydrates plus whey protein
• CHO
Oral supplement containing carbohydrates
• Fast
Fast condition of 12 hours

Locations

Country	Name	City	State
Brazil	Centro Universitário de Varzea Grande (UNIVAG)	Varzea Grande	Mato Grosso

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Mato Grosso	Univag Centro Universitário

Country where clinical trial is conducted

Brazil, 

Outcome

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