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

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412136
• Other study ID #: 29191
• Status: Completed
• Phase: N/A
• First received: January 6, 2018
• Last updated: January 19, 2018
• Start date: March 8, 2014
• Est. completion date: April 10, 2016

Study information

• Verified date: January 2018
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 10, 2016
• Est. primary completion date: April 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 9 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appetitive Behavior
• Pediatric Obesity

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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. Review. — View 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. — View 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. — View 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. — View 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. Epub 2006 Dec 18. — View 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 establish — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Appetite Biomarkers- Glucose	Glucose. Units were measured in mg/dl.	0-85 minutes
Secondary	Appetite Biomarkers- Glucagon-like peptide-1	Glucagon-like peptide-1. Units were measured in pM.	0-85 minutes
Secondary	Appetite Biomarkers- Active Ghrelin	Active Ghrelin. Units were measured in pg/ml.	0-85 minutes
Secondary	Appetite Biomarkers- Insulin	Insulin. Units were measured in uIu/ml.	0-85 minutes
Secondary	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).	0-85 minutes
Secondary	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).	0-85 minutes
Secondary	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).	0-85 minutes
Secondary	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).	0-85 minutes
Secondary	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.	65-85 minutes