NCT02487342

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

6 months

First QC Date

June 18, 2015

Last Update Submit

September 27, 2016

Conditions

Appetite Regulation

Keywords

Dairyappetitefeeding behaviour

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Postprandial glucagonlike peptide-1 (GLP) area under the curve

    180 min

Other Outcomes (7)

  • Postprandial insulin area under the curve

    180 min

  • Postprandial leptin area under the curve

    180 min

  • Postprandial blood glucose area under the curve

    180 min

  • +4 more other outcomes

Study Arms (2)

milk

EXPERIMENTAL

semi-skimmed milk (\< 2% fat, Tesco, UK). All items were isovolumetric (217 mL) and isoenergetic (427 kJ).

Other: milk

orange fruit-juice

ACTIVE COMPARATOR

orange fruit-juice (Tesco, UK). All items were isovolumetric (217 mL) and isoenergetic (427 kJ).

Other: orange fruit-juice

Interventions

milkOTHER

small serving (217 mL) of british semi-skimmed milk

milk
orange fruit-juiceOTHER

small serving (217 mL) of orange juice

orange fruit-juice

Eligibility Criteria

Age15 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male
  • Non diabetic
  • yrs

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding Behavior

Interventions

Milk

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Benjamin P Green, MSc

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

June 18, 2015

First Posted

July 1, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 28, 2016

Record last verified: 2016-09