The Acute Effect of Protein or Carbohydrate Intake on Testosterone Levels and Food Intake in Children and Adolescent Boys

January 19, 2018 updated by: G. Harvey Anderson, University of Toronto

Acute Decrease in Serum Testosterone After Glucose and Protein Beverages in Adolescent Males

The purpose of this study was to determine the effect of acute protein and glucose intake on testosterone levels measured in adolescent boys and determine whether changes in testosterone levels are associated with alterations in short-term food intake. It was hypothesized that 1) ingestion of a protein beverage would result in no change of testosterone levels whereas glucose would result in a significant decrease of testosterone levels 60 minutes after ingestion and 2) decreases of testosterone levels as a result of the glucose preload would predict food intake for boys of similar body size. The first objective was to investigate the effect of an acute protein or glucose drink on testosterone levels and the second objective was to determine whether changes of testosterone levels associate with food intake.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 3E2
        • University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 9-18 years, healthy, male.

Exclusion Criteria:

  • History of prematurity, chronic illness, were taking any medications known to affect glucose homeostasis, appetite or pubertal development.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
Dietary supplement: Control
Participants were given 5 minutes to ingest the non-caloric beverage which contained 1.5ml of chocolate extract (Vanilla Food Company, Markham, Ontario, Canada) to account for the flavor differences and mixed with 500ml of water and sweetened with 0.2g sucralose (Tate & Lyle, Stoney Creek, Ontario, Canada) in order to match sweetness with the glucose beverage.
Experimental: Glucose
Dietary supplement: Glucose
Participants were given 5 minutes to ingest the beverage which contained either 1g of protein (plain whey-protein isolate; BiPro USA., Eden Prairie, Minnesota, U.S.A) per kg of bodyweight and was flavoured with 1.5ml of chocolate extract (Vanilla Food Company, Markham, Ontario, Canada) to account for the flavor differences and mixed with 500ml of water.
Experimental: Protein
Dietary supplement: Protein
Participants were given 5 minutes to ingest the beverage which contained 1g of glucose monohydrate (BioShop Canada Inc., Burlington, Ontario, Canada) per kg of bodyweight and flavoured with 1.5ml of chocolate extract (Vanilla Food Company, Markham, Ontario, Canada) to account for the flavor differences and mixed with 500ml of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testosterone Change
Time Frame: 0-65 minutes
The first blood draw was taken prior to ingesting the experimental beverage at baseline (0 minutes). Participants were then given 5 minutes to ingest the beverage, and blood was later obtained 20, 35 and 65 minutes after baseline blood draw. Units were measured in ng/dl.
0-65 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite Biomarkers- Glucose
Time Frame: 0-85 minutes
Glucose. Units were measured in mg/dl.
0-85 minutes
Appetite Biomarkers- Glucagon-like peptide-1
Time Frame: 0-85 minutes
Glucagon-like peptide-1. Units were measured in pM.
0-85 minutes
Appetite Biomarkers- Active Ghrelin
Time Frame: 0-85 minutes
Active Ghrelin. Units were measured in pg/ml.
0-85 minutes
Appetite Biomarkers- Insulin
Time Frame: 0-85 minutes
Insulin. Units were measured in uIu/ml.
0-85 minutes
Subjective Appetite- Determination to eat
Time Frame: 0-85 minutes
Visual Analog Scales were employed to assess subjective appetite based on the Determination to Eat. Units were measured in mm (based on a 100mm scale).
0-85 minutes
Subjective Appetite- Hunger
Time Frame: 0-85 minutes
Visual Analog Scales were employed to assess subjective appetite based on feelings of Hunger. Units were measured in mm (based on a 100mm scale).
0-85 minutes
Subjective Appetite- Fullness
Time Frame: 0-85 minutes
Visual Analog Scales were employed to assess subjective appetite based on feelings of FullnessUnits were measured in mm (based on a 100mm scale).
0-85 minutes
Subjective Appetite- Prospective Food Consumption
Time Frame: 0-85 minutes
Visual Analog Scales were employed to assess subjective appetite based on Prospective Food Consumption. Units were measured in mm (based on a 100mm scale).
0-85 minutes
Food Intake
Time Frame: 65-85 minutes
Participants were provided an ad libitum pizza meal. The participants were instructed to eat during the next 20 min until they were comfortably full. Based on the participant preferences determined during screening, two varieties of Deep 'N Delicious 5-inch-diameter pizza were provided for consumption; pepperoni and three-cheese pizzas (McCain Canada Ltd., Florenceville, Ontario, Canada). Units were measuring in kcal.
65-85 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2014

Primary Completion (Actual)

April 10, 2016

Study Completion (Actual)

April 10, 2016

Study Registration Dates

First Submitted

January 6, 2018

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made available to other researchers.Participant's identities will be kept confidential. Records will be kept in a locked filing cabinet in the Fitzgerald building at 150 College Street, room 305. Access will be restricted to those directly involved with the project, such as the investigator and the co-investigators. Following recruitment and attainment of informed consent, participants will be given an ID # which will be used on all forms and data analysis. Informed consent forms will be kept in a locked cabinet in a locked office, contain participant names. Research records will be identified by initials, ID number, test and date. Results identified by date and ID number will only be entered on password-protected personal computers kept in locked laboratories or offices at the University of Toronto. Any electronic data will be held on encrypted computers and USB sticks for the same period of time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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