Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers

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

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

Study Overview

• Status: Recruiting
• Conditions: Insulin Resistance; Ketosis; Acute-Phase Response
• Intervention / Treatment: Dietary supplement: Fast; Dietary supplement: CHO+WP; Dietary supplement: CHO

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Nascimento, MD, PhD; Phone Number: +5565999815388; Email: jose.aguilar@univag.edu.br

Study Locations

• Brazil
  • Mato Grosso
    • Varzea Grande, Mato Grosso, Brazil, 78.118-000
      • Recruiting
      • Centro Universitário de Varzea Grande (UNIVAG)
      • Contact: Thais C Dombroski, PhD; Phone Number: +55 653688-6111; Email: cep@univag.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 12 hours Fast - Fast Group; Participants will proceed in 12 hours fast condition for blood collection for laboratory assays	Dietary supplement: Fast; Fast condition of 12 hours
Active Comparator: Carbohydrate plus whey protein supplement - CHO+WP group; 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	Dietary supplement: CHO+WP; Oral supplement containing carbohydrates plus whey protein
Placebo Comparator: Carbohydrate supplement - CHO group; 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	Dietary supplement: CHO; Oral supplement containing carbohydrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Federal University of Mato Grosso
• Collaborators: Univag Centro Universitário
• Investigators: Principal Investigator: Jose E Nascimento, MD, PhD, Univag Centro Universitário

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): January 30, 2023

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Fasting; Ketone bodies; Whey protein
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Inflammation; Hyperinsulinism; Insulin Resistance; Acute-Phase Reaction
• Other Study ID Numbers: 42481121.3.0000.5692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD will be shared with researchers that contact with the investigator
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: email do jose.aguilar@univag.edu.br
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No