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

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ClinicalTrials.gov Identifier: NCT02487342
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : September 28, 2016
Sponsor:
Collaborator:
Dairy Council, United Kingdom
Information provided by (Responsible Party):
Ben Green, Northumbria University

Brief 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).

Condition or disease Intervention/treatment Phase
Appetite Regulation Other: milk Other: orange fruit-juice Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Metabolic, Endocrine and Appetite-related Responses in Healthy, Adolescent Males After Acute and Daily Milk Consumption
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Subjective appetite [ Time Frame: 180 min ]
    Subjective measures of appetite were collected at 30 min intervals throughout the 180 min protocol.



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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487342


Sponsors and Collaborators
Northumbria University
Dairy Council, United Kingdom
Investigators
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Principal Investigator: Benjamin P Green, MSc Northumbria University

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Responsible Party: Ben Green, Mr, Northumbria University
ClinicalTrials.gov Identifier: NCT02487342     History of Changes
Other Study ID Numbers: HLS-12-290413
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Keywords provided by Ben Green, Northumbria University:
Dairy
appetite
feeding behaviour