Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers

NCT05656339 | Unknown

• 1 other identifier: 42481121.3.0000.5692
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Ketosis; Acute-Phase Response; Insulin Resistance

Keywords

Ketone bodies; Whey protein; Fasting

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

12 hours Fast - Fast Group

SHAM COMPARATOR

Participants will proceed in 12 hours fast condition for blood collection for laboratory assays

Dietary Supplement: Fast

Carbohydrate plus whey protein supplement - CHO+WP group

ACTIVE COMPARATOR

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

Carbohydrate supplement - CHO group

PLACEBO COMPARATOR

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

Interventions

CHO+WP DIETARY_SUPPLEMENT

Oral supplement containing carbohydrates plus whey protein

Carbohydrate plus whey protein supplement - CHO+WP group

CHO DIETARY_SUPPLEMENT

Oral supplement containing carbohydrates

Carbohydrate supplement - CHO group

Fast DIETARY_SUPPLEMENT

Fast condition of 12 hours

12 hours Fast - Fast Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male young healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Mato Grosso: lead
• Univag Centro Universitário: collaborator

Study Sites (1)

Centro Universitário de Varzea Grande (UNIVAG)

Várzea Grande, Mato Grosso, 78.118-000, Brazil

RECRUITING

MeSH Terms

Conditions

Ketosis; Acute-Phase Reaction; Insulin Resistance; Fasting

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Feeding Behavior; Behavior

Study Officials

• Jose E Nascimento, MD, PhD

  Univag Centro Universitário

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Nascimento, MD, PhD

CONTACT

+5565999815388; jose.aguilar@univag.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will not know the randomization nor the phases of the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Male volunteers, aged between 18 and 27 years, healthy, with no report of acute illness during 3 months prior to the study will be included. Individuals with obesity (calculated body mass index above 30 kg/m2), those who reported consumption of alcoholic beverages or any nutritional supplement during the study period will be excluded. The 30 selected volunteers will be scheduled to came to the laboratory after an overnight fast of 12 hours. Participants in the fasting group will immediately collect blood samples. The CHO and the CHO+WP groups will drink 200 ml of the respective supplements described above. After an interval of three hours after ingestion of the supplement, blood samples will be collected again for biochemical assays.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 19, 2022
• Study Start: November 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 year
• Access Criteria: email do jose.aguilar@univag.edu.br

Locations

BR (1)