The Acute Effect of Protein or Carbohydrate Intake on Testosterone Levels and Food Intake in Children and Adolescent Boys
Acute Decrease in Serum Testosterone After Glucose and Protein Beverages in Adolescent Males
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2016
CompletedFirst Submitted
Initial submission to the registry
January 6, 2018
CompletedFirst Posted
Study publicly available on registry
January 26, 2018
CompletedJanuary 26, 2018
January 1, 2018
2.1 years
January 6, 2018
January 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
0-65 minutes
Secondary Outcomes (9)
Appetite Biomarkers- Glucose
0-85 minutes
Appetite Biomarkers- Glucagon-like peptide-1
0-85 minutes
Appetite Biomarkers- Active Ghrelin
0-85 minutes
Appetite Biomarkers- Insulin
0-85 minutes
Subjective Appetite- Determination to eat
0-85 minutes
- +4 more secondary outcomes
Study Arms (3)
Control
EXPERIMENTALGlucose
EXPERIMENTALProtein
EXPERIMENTALInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- years, healthy, male.
You may not qualify if:
- History of prematurity, chronic illness, were taking any medications known to affect glucose homeostasis, appetite or pubertal development.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Toronto
Toronto, Ontario, M5S 3E2, Canada
Related Publications (8)
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.
PMID: 25308907BACKGROUNDAnderson 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.
PMID: 3573976BACKGROUNDCaronia 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.
PMID: 22804876BACKGROUNDAnderson 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.
PMID: 26773031BACKGROUNDKonforte 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.
PMID: 23637248RESULTDu 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.
PMID: 17178807RESULTCaufriez 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.
PMID: 9138969RESULTSchwartz 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.
PMID: 31055857DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
January 6, 2018
First Posted
January 26, 2018
Study Start
March 8, 2014
Primary Completion
April 10, 2016
Study Completion
April 10, 2016
Last Updated
January 26, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share
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.