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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02487342
Other study ID # HLS-12-290413
Secondary ID
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


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
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