NCT03412136

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

2.1 years

First QC Date

January 6, 2018

Last Update Submit

January 19, 2018

Conditions

Keywords

TestosteroneFood IntakeAppetite

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

EXPERIMENTAL
Dietary Supplement: Control

Glucose

EXPERIMENTAL
Dietary Supplement: Glucose

Protein

EXPERIMENTAL
Dietary Supplement: Protein

Interventions

ControlDIETARY_SUPPLEMENT

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.

Control
GlucoseDIETARY_SUPPLEMENT

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.

Glucose
ProteinDIETARY_SUPPLEMENT

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.

Protein

Eligibility Criteria

Age9 Years - 18 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsNormal 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.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Location

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: 25308907BACKGROUND
  • 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.

    PMID: 3573976BACKGROUND
  • 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.

    PMID: 22804876BACKGROUND
  • 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.

    PMID: 26773031BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Appetitive BehaviorPediatric Obesity

Interventions

GlucoseProteins

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesAmino Acids, Peptides, and Proteins

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
Model Details: 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).
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.

Locations