NCT01358591

Brief Summary

The purpose of this study is to assess the effect of a high calcium breakfast on substrate metabolism during exercise and appetite throughout the day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

Enrollment Period

6 months

First QC Date

May 20, 2011

Last Update Submit

June 2, 2012

Conditions

Exercise Fat Oxidation

Outcome Measures

Primary Outcomes (1)

  • Total fat oxidised during 60 min of exercise (g).

    Assessed by indirect calorimetry

    1 hour

Secondary Outcomes (3)

  • Blood glucose concentration

    2 hour

  • Serum Insulin Concentration

    2 hour

  • Subjective appetite ratings

    3 hour

Study Arms (2)

Control Breakfast

SHAM COMPARATOR

Normal calcium breakfast.

Dietary Supplement: Control

High calcium breakfast

EXPERIMENTAL

High calcium breakfast.

Dietary Supplement: High calcium milk

Interventions

High calcium milkDIETARY_SUPPLEMENT

High calcium milk (9 mg/kgBM)

High calcium breakfast
ControlDIETARY_SUPPLEMENT

Regular Milk

Control Breakfast

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Aged 18-45 years
  • Physically active - able to run continuously for 1 h.

You may not qualify if:

  • Smokers
  • Food Allergies
  • Metabolic Disorders
  • Consuming herbal/dietary supplements
  • Gastric Problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

May 20, 2011

First Posted

May 23, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations

GB(1)