Metabolic, Endocrine and Appetite-related Responses in Healthy, Adolescent Males After Acute and Daily Milk Consumption

Appetite Regulation Clinical Trial

Official title:

Metabolic, Endocrine and Appetite-related Responses in Healthy, Adolescent Males After Acute and Daily Milk Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487342
• Other study ID #: HLS-12-290413
• Status: Completed
• Phase: N/A
• First received: June 18, 2015
• Last updated: September 27, 2016
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2016
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Comprising two experiments, the investigators assessed the metabolic, endocrine and appetite-related responses to acute (1-d, part 1) and daily mid-morning milk consumption (28-d, part 2) in adolescent males (15-18 y).

Description:

The aims of the present study were twofold. Firstly, this study sought to examine the acute (1-d) effects of mid-morning milk consumption on subsequent metabolic, endocrine and appetite-related responses relative to an isoenergetic and isovolumetric serving of fruit-juice (part 1). Considering the putative mechanisms of milk consumption on appetite, feeding behavior and metabolism no studies are available that have explored the impact of daily milk or dairy food consumption on the above mentioned constructs in children and adolescents. This study therefore also aimed to compare the effect of daily (28-d) mid-morning milk or fruit-juice consumption on the above mentioned constructs (part 2).

Eleven adolescents participated in part 1 of this study and completed two trials (milk or fruit-juice mid-morning snack) in a randomized crossover design. For part 2, a parallel design with two intervention groups was employed. Participants were randomly allocated to groups, and received either a milk (n = 10) or an isocaloric and isovolumetric fruit-juice (n = 9) mid-morning snack for 28-d. On laboratory visits (for both part 1 and 2) participants remained at rest for 180 min. During this time, circulating concentrations of GLP-17-36, glucagon, insulin, leptin and blood glucose were determined. Measures of energy expenditure, substrate metabolism and subjective appetite were also collected. At 180 min, a homogenous ad libitum pasta meal was provided. For the remainder of the study day, subsequent energy intake was recorded utilizing a combined weighed self-reported food record and 24-h dietary recall technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Male

2. Non diabetic

3. 15-18 yrs

Exclusion Criteria:

1. Are outside of the stipulated age range (15-18 years old)

2. A diabetic

3. Hold an aversion/dislike to milk, milk based products and the test meals provided.

4. Are known to be lactose intolerant

5. Currently taking any form of medication known to affect taste, smell and appetite

6. Female

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Appetite Regulation

Intervention

Other:
• milk
small serving (217 mL) of british semi-skimmed milk
• orange fruit-juice
small serving (217 mL) of orange juice

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Dairy Council, United Kingdom

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postprandial insulin area under the curve	Fingertip-capillary measures of insulin were collected at 30 min intervals throughout the 180 min protocol.	180 min	No
Other	Postprandial leptin area under the curve	Fingertip-capillary measures of insulin were collected at 30 min intervals throughout the 180 min protocol.	180 min	No
Other	Postprandial blood glucose area under the curve	Fingertip-capillary measures of insulin were collected at 30 min intervals throughout the 180 min protocol.	180 min	No
Other	Feeding behaviour	Energy intake was assessed at 180 min via an ad libitum pasta meal. Here subjects ate the pasta meal until they identified they were comfortably full. On completion of this, participants self-reported their energy intake for the remainder of the study day after leaving the laboratory.	assessed at 180 min and following 24 h	No
Other	Energy Expenditure	Measures of energy expenditure were calculated, through the use of Douglass Bags, for 300 seconds at 30 min intervals throughout the 180 min protocol.	180 min	No
Other	Substrate oxidation	Measures of substrate oxidation were calculated, through the use of Douglass Bags, for 300 seconds at 30 min intervals throughout the 180 min protocol.	180 min	No
Other	Subjective appetite	Subjective measures of appetite were collected at 30 min intervals throughout the 180 min protocol.	180 min	No
Primary	Postprandial glucagon area under the curve	Fingertip-capillary measures of GLP-1 were collected at 30 min intervals throughout the 180 min protocol.	180 min	No
Secondary	Postprandial glucagonlike peptide-1 (GLP) area under the curve	Fingertip-capillary measures of glucagon were collected at 30 min intervals throughout the 180 min protocol.	180 min	No