Clinical trial NCT03412136: 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
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Pediatric Obesity
Keywords: Testosterone
Food Intake
Appetite
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-01-26
Enrollment: 34
Sex: MALE
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Testosterone Change
timeFrame: 0-65 minutes
Secondary outcomes:
measure: Appetite Biomarkers- Glucose
timeFrame: 0-85 minutes
measure: Appetite Biomarkers- Glucagon-like peptide-1
timeFrame: 0-85 minutes
measure: Appetite Biomarkers- Active Ghrelin
timeFrame: 0-85 minutes
measure: Appetite Biomarkers- Insulin
timeFrame: 0-85 minutes
measure: Subjective Appetite- Determination to eat
timeFrame: 0-85 minutes
measure: Subjective Appetite- Hunger
timeFrame: 0-85 minutes
measure: Subjective Appetite- Fullness
timeFrame: 0-85 minutes
measure: Subjective Appetite- Prospective Food Consumption
timeFrame: 0-85 minutes
measure: Food Intake
timeFrame: 65-85 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
References:
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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.
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.
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.