Appetitive BehaviorNCT03412136
The Acute Effect of Protein or Carbohydrate Intake on Testosterone Levels and Food Intake in Children and Adolescent Boys
A study testing Glucose and Protein in people with Appetitive Behavior and Pediatric Obesity, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 9 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior, Pediatric Obesity
- What is being tested?
- Glucose and Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 8 Mar 2014to 10 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 9-18 years, healthy, male.
Who cannot join
- History of prematurity, chronic illness, were taking any medications known to affect glucose homeostasis, appetite or pubertal development.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Decrease in Serum Testosterone After Glucose and Protein Beverages in Adolescent Males
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.
- Conditions
- Appetitive Behavior, Pediatric Obesity
- Being tested
- Control, Glucose, Protein
- Keywords
- Testosterone, Food Intake, Appetite
- Medical subject headings
- Appetitive Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Not described Receives: Dietary Supplement: Control |
| Glucose | Experimental | Not described Receives: Dietary Supplement: Glucose |
| Protein | Experimental | Not described Receives: Dietary Supplement: Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-65 minutes
Secondary outcomes (9)
Appetite Biomarkers- Glucose
Glucose. Units were measured in mg/dl.
Measured: 0-85 minutes
Appetite Biomarkers- Glucagon-like peptide-1
Glucagon-like peptide-1. Units were measured in pM.
Measured: 0-85 minutes
Appetite Biomarkers- Active Ghrelin
Active Ghrelin. Units were measured in pg/ml.
Measured: 0-85 minutes
Appetite Biomarkers- Insulin
Insulin. Units were measured in uIu/ml.
Measured: 0-85 minutes
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).
Measured: 0-85 minutes
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).
Measured: 0-85 minutes
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).
Measured: 0-85 minutes
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).
Measured: 0-85 minutes
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.
Measured: 65-85 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start8 Mar 2014
- Primary completion10 Apr 2016
- Study completion10 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412136
- Sponsor's protocol ID
- 29191
- Status last verified
- Jan 2018
- First submitted
- 6 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 25308907Anderson 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.
PubMed 3573976Caronia 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.
PubMed 22804876Anderson 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.
PubMed 26773031Konforte 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.
PubMed 23637248Du 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.
PubMed 17178807Caufriez 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.
PubMed 9138969Schwartz 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.
PubMed 31055857
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Decrease in Serum Testosterone After Glucose and Protein Beverages in Adolescent Males
- ClinicalTrials.gov ID
- NCT03412136
- Acronym / sponsor ID
- 29191
- Conditions
- Appetitive Behavior, Pediatric Obesity
- Keywords
- Testosterone, Food Intake, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 8 Mar 2014 (actual)
- Primary completion
- 10 Apr 2016 (actual)
- Study completion
- 10 Apr 2016 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Dietary Supplement: Control |
| Glucose | Experimental | Dietary Supplement: Glucose |
| Protein | Experimental | Dietary Supplement: Protein |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 9-18 years, healthy, male.
Key exclusion criteria (1 listed)
- History of prematurity, chronic illness, were taking any medications known to affect glucose homeostasis, appetite or pubertal development.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlParticipants 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. | Dietary supplement | Control |
| GlucoseParticipants 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. | Dietary supplement | Glucose |
| ProteinParticipants 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. | Dietary supplement | Protein |
Primary outcome
Testosterone Change
Time frame: 0-65 minutes
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.
9 secondary outcomes
Appetite Biomarkers- Glucose
Time frame: 0-85 minutes
Appetite Biomarkers- Glucagon-like peptide-1
Time frame: 0-85 minutes
Appetite Biomarkers- Active Ghrelin
Time frame: 0-85 minutes
Appetite Biomarkers- Insulin
Time frame: 0-85 minutes
Subjective Appetite- Determination to eat
Time frame: 0-85 minutes
Subjective Appetite- Hunger
Time frame: 0-85 minutes
Subjective Appetite- Fullness
Time frame: 0-85 minutes
Subjective Appetite- Prospective Food Consumption
Time frame: 0-85 minutes
Food Intake
Time frame: 65-85 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Background: PubMed 25308907Schwartz 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.
- Background: PubMed 3573976Anderson 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.
- Background: PubMed 22804876Caronia 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.
- Background: PubMed 26773031Anderson 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 publication: PubMed 23637248Konforte 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 publication: PubMed 17178807Du 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 publication: PubMed 9138969Caufriez 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.
- Derived from this study: PubMed 31055857Schwartz 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose and Protein in people with Appetitive Behavior and Pediatric Obesity, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testosterone Change (time frame: 0-65 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03412136, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.