Appetite RegulationNCT02487342
Metabolic, Endocrine and Appetite-related Responses in Healthy, Adolescent Males After Acute and Daily Milk Consumption
A study testing milk and orange fruit-juice in people with Appetite Regulation, run by Northumbria University.
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). Read more about this study
- Who is it for?
- Ages 15 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation
- What is being tested?
- milk and orange fruit-juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male
- Non diabetic
- 15-18 yrs
Who cannot join
- Are outside of the stipulated age range (15-18 years old)
- A diabetic
- Hold an aversion/dislike to milk, milk based products and the test meals provided.
- Are known to be lactose intolerant
- Currently taking any form of medication known to affect taste, smell and appetite
- Female
About this study
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).
Read the 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.
- Conditions
- Appetite Regulation
- Being tested
- milk, orange fruit-juice
- Keywords
- Dairy, appetite, feeding behaviour
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milkOther
small serving (217 mL) of british semi-skimmed milk
orange fruit-juiceOther
small serving (217 mL) of orange juice
| Study group | Role | What they receive |
|---|---|---|
| milk | Experimental | semi-skimmed milk (< 2% fat, Tesco, UK). All items were isovolumetric (217 mL) and isoenergetic (427 kJ). Receives: Other: milk |
| orange fruit-juice | Active comparator | orange fruit-juice (Tesco, UK). All items were isovolumetric (217 mL) and isoenergetic (427 kJ). Receives: Other: orange fruit-juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucagon area under the curve
Fingertip-capillary measures of GLP-1 were collected at 30 min intervals throughout the 180 min protocol.
Measured: 180 min
Secondary outcomes (1)
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.
Measured: 180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetite RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Council, United Kingdom
- Responsible party
- Principal investigator, Ben Green, Northumbria University
- Investigators
- Benjamin P Green, MSc, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487342
- Sponsor's protocol ID
- HLS-12-290413
- Status last verified
- Sep 2016
- First submitted
- 18 Jun 2015
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic, Endocrine and Appetite-related Responses in Healthy, Adolescent Males After Acute and Daily Milk Consumption
- ClinicalTrials.gov ID
- NCT02487342
- Acronym / sponsor ID
- HLS-12-290413
- Conditions
- Appetite Regulation
- Keywords
- Dairy, appetite, feeding behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Dairy Council, United Kingdom
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| milk | Experimental | Other: milksemi-skimmed milk (< 2% fat, Tesco, UK). All items were isovolumetric (217 mL) and isoenergetic (427 kJ). |
| orange fruit-juice | Active comparator | Other: orange fruit-juiceorange fruit-juice (Tesco, UK). All items were isovolumetric (217 mL) and isoenergetic (427 kJ). |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male
- Non diabetic
- 15-18 yrs
Key exclusion criteria (6 listed)
- Are outside of the stipulated age range (15-18 years old)
- A diabetic
- Hold an aversion/dislike to milk, milk based products and the test meals provided.
- Are known to be lactose intolerant
- Currently taking any form of medication known to affect taste, smell and appetite
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| milksmall serving (217 mL) of british semi-skimmed milk | Other | milk |
| orange fruit-juicesmall serving (217 mL) of orange juice | Other | orange fruit-juice |
Primary outcome
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.
1 secondary outcome
Postprandial glucagonlike peptide-1 (GLP) area under the curve
Time frame: 180 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin P Green, MSc principal investigator
Northumbria University
Questions about this trial
What is this clinical trial studying?
A study testing milk and orange fruit-juice in people with Appetite Regulation, run by Northumbria University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucagon area under the curve (time frame: 180 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.