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

Primary Purpose

Appetitive Behavior, Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Control
Glucose
Protein
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Appetitive Behavior focused on measuring Testosterone, Food Intake, Appetite

Eligibility Criteria

9 Years - 18 Years (Child, Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control

Glucose

Protein

Arm Description

Outcomes

Primary Outcome Measures

Testosterone Change
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.

Secondary Outcome Measures

Appetite Biomarkers- Glucose
Glucose. Units were measured in mg/dl.
Appetite Biomarkers- Glucagon-like peptide-1
Glucagon-like peptide-1. Units were measured in pM.
Appetite Biomarkers- Active Ghrelin
Active Ghrelin. Units were measured in pg/ml.
Appetite Biomarkers- Insulin
Insulin. Units were measured in uIu/ml.
Subjective Appetite- Determination to eat
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).
Subjective Appetite- Hunger
Visual Analog Scales were employed to assess subjective appetite based on feelings of Hunger. Units were measured in mm (based on a 100mm scale).
Subjective Appetite- Fullness
Visual Analog Scales were employed to assess subjective appetite based on feelings of FullnessUnits were measured in mm (based on a 100mm scale).
Subjective Appetite- Prospective Food Consumption
Visual Analog Scales were employed to assess subjective appetite based on Prospective Food Consumption. Units were measured in mm (based on a 100mm scale).
Food Intake
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.

Full Information

First Posted
January 6, 2018
Last Updated
January 19, 2018
Sponsor
University of Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03412136
Brief Title
The Acute Effect of Protein or Carbohydrate Intake on Testosterone Levels and Food Intake in Children and Adolescent Boys
Official Title
Acute Decrease in Serum Testosterone After Glucose and Protein Beverages in Adolescent Males
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 8, 2014 (Actual)
Primary Completion Date
April 10, 2016 (Actual)
Study Completion Date
April 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetitive Behavior, Pediatric Obesity
Keywords
Testosterone, Food Intake, Appetite

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
In a randomized, crossover study, sixteen 9-18 y old males were given beverages containing either: 1) whey protein (1g/kg bodyweight), 2) glucose (1g/kg bodyweight) or a calorie-free control (C). Serum testosterone, appetite biomarkers and subjective appetite were measured prior (0) and at 20, 35 and 65 minutes after the consumption of the beverage. Food intake at an ad libitum pizza meal was assessed 20 min later (65-85min).
Masking
Participant
Masking Description
The experimental beverages contained either 1g of glucose monohydrate (BioShop Canada Inc., Burlington, Ontario, Canada) or 1g of protein (plain whey-protein isolate; BiPro USA., Eden Prairie, Minnesota, U.S.A) per kg of bodyweight. A non-calorie drink was used as control. All beverages were 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. The whey protein and control beverages were sweetened with 0.2g sucralose (Tate & Lyle, Stoney Creek, Ontario, Canada) in order to match sweetness with the glucose beverage.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Title
Glucose
Arm Type
Experimental
Arm Title
Protein
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein
Intervention Description
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.
Primary Outcome Measure Information:
Title
Testosterone Change
Description
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.
Time Frame
0-65 minutes
Secondary Outcome Measure Information:
Title
Appetite Biomarkers- Glucose
Description
Glucose. Units were measured in mg/dl.
Time Frame
0-85 minutes
Title
Appetite Biomarkers- Glucagon-like peptide-1
Description
Glucagon-like peptide-1. Units were measured in pM.
Time Frame
0-85 minutes
Title
Appetite Biomarkers- Active Ghrelin
Description
Active Ghrelin. Units were measured in pg/ml.
Time Frame
0-85 minutes
Title
Appetite Biomarkers- Insulin
Description
Insulin. Units were measured in uIu/ml.
Time Frame
0-85 minutes
Title
Subjective Appetite- Determination to eat
Description
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).
Time Frame
0-85 minutes
Title
Subjective Appetite- Hunger
Description
Visual Analog Scales were employed to assess subjective appetite based on feelings of Hunger. Units were measured in mm (based on a 100mm scale).
Time Frame
0-85 minutes
Title
Subjective Appetite- Fullness
Description
Visual Analog Scales were employed to assess subjective appetite based on feelings of FullnessUnits were measured in mm (based on a 100mm scale).
Time Frame
0-85 minutes
Title
Subjective Appetite- Prospective Food Consumption
Description
Visual Analog Scales were employed to assess subjective appetite based on Prospective Food Consumption. Units were measured in mm (based on a 100mm scale).
Time Frame
0-85 minutes
Title
Food Intake
Description
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.
Time Frame
65-85 minutes

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Normal weight and overweight/obese adolescent males (n=34) age 9 to 18 were recruited via print advertisement in the local Toronto newspaper. verweight was categorized as in the 85th-95th percentile and obesity in ≥95th percentile.
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
25308907
Citation
Schwartz A, Patel BP, Vien S, McCrindle BW, Anderson GH, Hamilton J. Acute decrease in serum testosterone after a mixed glucose and protein beverage in obese peripubertal boys. Clin Endocrinol (Oxf). 2015 Sep;83(3):332-8. doi: 10.1111/cen.12630. Epub 2014 Nov 27.
Results Reference
background
PubMed Identifier
3573976
Citation
Anderson KE, Rosner W, Khan MS, New MI, Pang SY, Wissel PS, Kappas A. Diet-hormone interactions: protein/carbohydrate ratio alters reciprocally the plasma levels of testosterone and cortisol and their respective binding globulins in man. Life Sci. 1987 May 4;40(18):1761-8. doi: 10.1016/0024-3205(87)90086-5.
Results Reference
background
PubMed Identifier
22804876
Citation
Caronia LM, Dwyer AA, Hayden D, Amati F, Pitteloud N, Hayes FJ. Abrupt decrease in serum testosterone levels after an oral glucose load in men: implications for screening for hypogonadism. Clin Endocrinol (Oxf). 2013 Feb;78(2):291-6. doi: 10.1111/j.1365-2265.2012.04486.x.
Results Reference
background
PubMed Identifier
26773031
Citation
Anderson GH, Hunschede S, Akilen R, Kubant R. Physiology of Food Intake Control in Children. Adv Nutr. 2016 Jan 15;7(1):232S-240S. doi: 10.3945/an.115.009357. Print 2016 Jan.
Results Reference
background
PubMed Identifier
23637248
Citation
Konforte D, Shea JL, Kyriakopoulou L, Colantonio D, Cohen AH, Shaw J, Bailey D, Chan MK, Armbruster D, Adeli K. Complex biological pattern of fertility hormones in children and adolescents: a study of healthy children from the CALIPER cohort and establishment of pediatric reference intervals. Clin Chem. 2013 Aug;59(8):1215-27. doi: 10.1373/clinchem.2013.204123. Epub 2013 May 1.
Results Reference
result
PubMed Identifier
17178807
Citation
Du M, Shen QW, Zhu MJ, Ford SP. Leucine stimulates mammalian target of rapamycin signaling in C2C12 myoblasts in part through inhibition of adenosine monophosphate-activated protein kinase. J Anim Sci. 2007 Apr;85(4):919-27. doi: 10.2527/jas.2006-342. Epub 2006 Dec 18.
Results Reference
result
PubMed Identifier
9138969
Citation
Caufriez A. The pubertal spurt: effects of sex steroids on growth hormone and insulin-like growth factor I. Eur J Obstet Gynecol Reprod Biol. 1997 Feb;71(2):215-7. doi: 10.1016/s0301-2115(96)02638-3.
Results Reference
result
PubMed Identifier
31055857
Citation
Schwartz A, Hunschede S, Lacombe RJS, Chatterjee D, Sanchez-Hernandez D, Kubant R, Bazinet RP, Hamilton JK, Anderson GH. Acute decrease in plasma testosterone and appetite after either glucose or protein beverages in adolescent males. Clin Endocrinol (Oxf). 2019 Aug;91(2):295-303. doi: 10.1111/cen.14005. Epub 2019 May 16.
Results Reference
derived

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

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