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Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers

Primary Purpose

Ketosis, Acute-Phase Response, Insulin Resistance

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CHO+WP
CHO
Fast
Sponsored by
Federal University of Mato Grosso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ketosis focused on measuring Ketone bodies, Whey protein, Fasting

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centro Universitário de Varzea Grande (UNIVAG)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Placebo Comparator

Arm Label

12 hours Fast - Fast Group

Carbohydrate plus whey protein supplement - CHO+WP group

Carbohydrate supplement - CHO group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in serum hydroxy butyrate
Serum hydroxy butyrate levels from 12 hours fast at 3 hours after ingestion of 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 in insulin resistance
Change of HOMA index from 12 hours fast (baseline) to 3 hours after ingestion of the oral supplement

Secondary Outcome Measures

Full Information

First Posted
November 22, 2022
Last Updated
December 9, 2022
Sponsor
Federal University of Mato Grosso
Collaborators
Univag Centro Universitário
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1. Study Identification

Unique Protocol Identification Number
NCT05656339
Brief Title
Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers
Official Title
Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers: A Controlled Randomized Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Mato Grosso
Collaborators
Univag Centro Universitário

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis, Acute-Phase Response, Insulin Resistance
Keywords
Ketone bodies, Whey protein, Fasting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Outcomes Assessor will not know the randomization nor the phases of the study.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
12 hours Fast - Fast Group
Arm Type
Sham Comparator
Arm Description
Participants will proceed in 12 hours fast condition for blood collection for laboratory assays
Arm Title
Carbohydrate plus whey protein supplement - CHO+WP group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Carbohydrate supplement - CHO group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
CHO+WP
Intervention Description
Oral supplement containing carbohydrates plus whey protein
Intervention Type
Dietary Supplement
Intervention Name(s)
CHO
Intervention Description
Oral supplement containing carbohydrates
Intervention Type
Dietary Supplement
Intervention Name(s)
Fast
Intervention Description
Fast condition of 12 hours
Primary Outcome Measure Information:
Title
Change in serum hydroxy butyrate
Description
Serum hydroxy butyrate levels from 12 hours fast at 3 hours after ingestion of oral supplement
Time Frame
Change from 12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement
Title
Change in acute phase response proteins
Description
Change of serum C reactive protein and albumin from 12 hours fast (baseline) to 3 hours after ingestion of the oral supplement
Time Frame
Change from12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement
Title
Change in insulin resistance
Description
Change of HOMA index from 12 hours fast (baseline) to 3 hours after ingestion of the oral supplement
Time Frame
Change from12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Nascimento, MD, PhD
Phone
+5565999815388
Email
jose.aguilar@univag.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose E Nascimento, MD, PhD
Organizational Affiliation
Univag Centro Universitário
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Universitário de Varzea Grande (UNIVAG)
City
Varzea Grande
State/Province
Mato Grosso
ZIP/Postal Code
78.118-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thais C Dombroski, PhD
Phone
+55 653688-6111
Email
cep@univag.edu.br

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers

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