NCT01779245

Brief Summary

A high-calcium intake can accelerate fat loss under energy-restricted diets. Part of this may be due to a shift in substrate metabolism where there is an increase in the rate of fat oxidation. However, whether high-calcium intake can influence substrate metabolism during exercise is not known. Accordingly, we aim to investigate the effect of 2 weeks of high-calcium intake on substrate metabolism during exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 6, 2013

Status Verified

September 1, 2013

Enrollment Period

4 months

First QC Date

January 28, 2013

Last Update Submit

September 4, 2013

Conditions

Lipid Metabolism

Outcome Measures

Primary Outcomes (1)

  • Substrate metabolism

    Substrate metabolism will be assessed by the respiratory exchange ratio (rate of carbon dioxide production/rate of oxygen consumption) from samples of expired gas collected during the first 15 minutes of an incremental cycling test.

    60 s samples every 3 min for 15 min

Secondary Outcomes (2)

  • Plasma non-esterified fatty acid concentrations

    Every 3 min for 15 min

  • Plasma glycerol concentrations

    Every 3 min for 15 min

Other Outcomes (3)

  • Serum parathyroid hormone concentration

    Baseline (Pre-post 2 week supplementation)

  • Plasma glucose-dependent insulinotropic peptide concentration

    Baseline (Pre-post 2 week supplementation)

  • Plasma glucagon-like peptide-1 concentration

    Baseline (Pre-post 2 week supplementation)

Study Arms (2)

Control

PLACEBO COMPARATOR

A chocolate milkshake with a normal calcium content will be consumed daily (235 kcal; 13 g protein; 42 g carbohydrate; 1 g fat, 400 mg calcium per serving).

Dietary Supplement: Placebo

High-Calcium

EXPERIMENTAL

A chocolate milkshake with a high calcium content will be consumed daily (235 kcal; 13 g protein; 42 g carbohydrate; 1 g fat, 1400 mg calcium per serving).

Dietary Supplement: Calcium

Interventions

CalciumDIETARY_SUPPLEMENT

Milk-extracted calcium supplement will be used to modulate the calcium content of the milkshakes used.

High-Calcium
PlaceboDIETARY_SUPPLEMENT
Control

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physically active (moderate-vigorous exercise \>3 time per week)
  • Male
  • yrs of age

You may not qualify if:

  • Smoker
  • Known Food Allergies
  • Metabolic disorders

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

MeSH Terms

Interventions

Calcium

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Emma J Stevenson, PhD

    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
Principal Investigator

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 30, 2013

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

September 6, 2013

Record last verified: 2013-09

Locations

GB(1)