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

September 27, 2016 updated by: Ben Green, Northumbria University
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).

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: milk
semi-skimmed milk (< 2% fat, Tesco, UK). All items were isovolumetric (217 mL) and isoenergetic (427 kJ).
small serving (217 mL) of british semi-skimmed milk
Active Comparator: orange fruit-juice
orange fruit-juice (Tesco, UK). All items were isovolumetric (217 mL) and isoenergetic (427 kJ).
small serving (217 mL) of orange juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glucagon area under the curve
Time Frame: 180 min
Fingertip-capillary measures of GLP-1 were collected at 30 min intervals throughout the 180 min protocol.
180 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glucagonlike peptide-1 (GLP) area under the curve
Time Frame: 180 min
Fingertip-capillary measures of glucagon were collected at 30 min intervals throughout the 180 min protocol.
180 min

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial insulin area under the curve
Time Frame: 180 min
Fingertip-capillary measures of insulin were collected at 30 min intervals throughout the 180 min protocol.
180 min
Postprandial leptin area under the curve
Time Frame: 180 min
Fingertip-capillary measures of insulin were collected at 30 min intervals throughout the 180 min protocol.
180 min
Postprandial blood glucose area under the curve
Time Frame: 180 min
Fingertip-capillary measures of insulin were collected at 30 min intervals throughout the 180 min protocol.
180 min
Feeding behaviour
Time Frame: assessed at 180 min and following 24 h
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
Energy Expenditure
Time Frame: 180 min
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
Substrate oxidation
Time Frame: 180 min
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
Subjective appetite
Time Frame: 180 min
Subjective measures of appetite were collected at 30 min intervals throughout the 180 min protocol.
180 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benjamin P Green, MSc, Northumbria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 18, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • HLS-12-290413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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