Exercise Fat OxidationNCT01358591
Effect of a High Calcium Breakfast on Exercise Metabolism and Appetite
A study testing High calcium milk in people with Exercise Fat Oxidation, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Fat Oxidation
- What is being tested?
- High calcium milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Nov 2011
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged 18-45 years
- Physically active - able to run continuously for 1 h.
Who cannot join
- Smokers
- Food Allergies
- Metabolic Disorders
- Consuming herbal/dietary supplements
- Gastric Problems
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
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.
- Conditions
- Exercise Fat Oxidation
- Being tested
- High calcium milk, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High calcium milkDietary supplement
High calcium milk (9 mg/kgBM)
ControlDietary supplement
Regular Milk
| Study group | Role | What they receive |
|---|---|---|
| Control Breakfast | Sham comparator | Normal calcium breakfast. Receives: Dietary Supplement: Control |
| High calcium breakfast | Experimental | High calcium breakfast. Receives: Dietary Supplement: High calcium milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fat oxidised during 60 min of exercise (g).
Assessed by indirect calorimetry
Measured: 1 hour
Secondary outcomes (3)
Blood glucose concentration
2 h incremental area under the curve for blood glucose following breakfast consumption
Measured: 2 hour
Serum Insulin Concentration
2 h area under the curve for serum insulin following breakfast consumption
Measured: 2 hour
Subjective appetite ratings
Subjective ratings of appetite assessed by visual analogue scales.
Measured: 3 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Fat OxidationStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358591
- Sponsor's protocol ID
- 32AN1
- Status last verified
- Jun 2012
- First submitted
- 20 May 2011
- Last updated
- 5 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a High Calcium Breakfast on Exercise Metabolism and Appetite
- ClinicalTrials.gov ID
- NCT01358591
- Acronym / sponsor ID
- 32AN1
- Conditions
- Exercise Fat Oxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 May 2011 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Breakfast | Sham comparator | Dietary Supplement: ControlNormal calcium breakfast. |
| High calcium breakfast | Experimental | Dietary Supplement: High calcium milkHigh calcium breakfast. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- Aged 18-45 years
- Physically active - able to run continuously for 1 h.
Key exclusion criteria (5 listed)
- Smokers
- Food Allergies
- Metabolic Disorders
- Consuming herbal/dietary supplements
- Gastric Problems
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 |
|---|---|---|
| High calcium milkHigh calcium milk (9 mg/kgBM) | Dietary supplement | High calcium breakfast |
| ControlRegular Milk | Dietary supplement | Control Breakfast |
Primary outcome
Total fat oxidised during 60 min of exercise (g).
Time frame: 1 hour
Assessed by indirect calorimetry
3 secondary outcomes
Blood glucose concentration
Time frame: 2 hour
Serum Insulin Concentration
Time frame: 2 hour
Subjective appetite ratings
Time frame: 3 hour
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 5 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High calcium milk in people with Exercise Fat Oxidation, run by Northumbria University at 1 site in United Kingdom.
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 5 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 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Total fat oxidised during 60 min of exercise (g). (time frame: 1 hour). 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 5 Jun 2012.