NCT01682343

Brief Summary

The purpose of this study is to investigate the appetite, insulin and incretin hormone responses to a high-calcium meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

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, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

3 months

First QC Date

September 6, 2012

Last Update Submit

September 10, 2012

Conditions

Nutritional and Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

  • Subjective appetite ratings

    Subjective ratings of appetite assessed by visual analogue scales.

    3 hour

Secondary Outcomes (3)

  • Serum insulin concentration

    2 hour

  • Plasma glucose-dependent insulinotropic peptide concentration

    2 hour

  • Plasma glucagon-like peptide-1 concentration

    2 hour

Other Outcomes (1)

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

    1 hour

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Breakfast consisting of milk-based porridge with a normal calcium content.

High-Calcium

EXPERIMENTAL

As control, but with a high-calcium content.

Dietary Supplement: Calcium

Interventions

CalciumDIETARY_SUPPLEMENT

Milk-calcium supplement

High-Calcium

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • recreationally active
  • male

You may not qualify if:

  • food intolerances/allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

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

Location

MeSH Terms

Conditions

Nutritional and Metabolic Diseases

Interventions

Calcium

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Javier T Gonzalez, MRes

    Northumbria University

    PRINCIPAL INVESTIGATOR

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

September 6, 2012

First Posted

September 10, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

GB(1)