Lipid MetabolismNCT01779245
Effect of High-calcium Intake on Substrate Metabolism During Exercise
A study testing Calcium in people with Lipid Metabolism, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism
- What is being tested?
- Calcium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Feb 2013
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active (moderate-vigorous exercise >3 time per week)
- Male
- 18-40 yrs of age
Who cannot join
- Smoker
- Known Food Allergies
- Metabolic disorders
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
Official title: The Impact of a Calcium Supplementation on Lipid Metabolism During Exercise.
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.
- Conditions
- Lipid Metabolism
- Being tested
- Calcium, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalciumDietary supplement
Milk-extracted calcium supplement will be used to modulate the calcium content of the milkshakes used.
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 s samples every 3 min for 15 min
Secondary outcomes (2)
Plasma non-esterified fatty acid concentrations
Non-esterified fatty acid concentrations will be determined from plasma samples collected during the first 15 minutes of an incremental cycling test to indicate fatty acid availability.
Measured: Every 3 min for 15 min
Plasma glycerol concentrations
Glycerol concentrations will be determined from plasma samples collected during the first 15 minutes of an incremental cycling test as a marker of lipolysis.
Measured: Every 3 min for 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid MetabolismStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, Northumbria University
- Investigators
- Emma J Stevenson, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779245
- Sponsor's protocol ID
- 32AN3
- Status last verified
- Sep 2013
- First submitted
- 28 Jan 2013
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Calcium Supplementation on Lipid Metabolism During Exercise.
- ClinicalTrials.gov ID
- NCT01779245
- Acronym / sponsor ID
- 32AN3
- Conditions
- Lipid Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 30 Jan 2013 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: PlaceboA 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). |
| High-Calcium | Experimental | Dietary Supplement: CalciumA 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Physically active (moderate-vigorous exercise >3 time per week)
- Male
- 18-40 yrs of age
Key exclusion criteria (3 listed)
- Smoker
- Known Food Allergies
- Metabolic disorders
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 |
|---|---|---|
| CalciumMilk-extracted calcium supplement will be used to modulate the calcium content of the milkshakes used. | Dietary supplement | High-Calcium |
| Placebo | Dietary supplement | Control |
Primary outcome
Substrate metabolism
Time frame: 60 s samples every 3 min for 15 min
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.
2 secondary outcomes
Plasma non-esterified fatty acid concentrations
Time frame: Every 3 min for 15 min
Plasma glycerol concentrations
Time frame: Every 3 min for 15 min
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 6 Sep 2013.
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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.
Emma J Stevenson, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium in people with Lipid Metabolism, 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 3 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 6 Sep 2013. 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?
Substrate metabolism (time frame: 60 s samples every 3 min for 15 min). 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 6 Sep 2013.