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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northumbria University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dairy Council, United Kingdom

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Appetite Regulation

Clinical Trials on milk

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings