Nutritional and Metabolic DiseasesNCT01682343
Effect of High-calcium Intake on Appetite, Insulinemia and Incretins
A study testing Calcium in people with Nutritional and Metabolic Diseases, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the appetite, insulin and incretin hormone responses to a high-calcium meal. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nutritional and Metabolic Diseases
- What is being tested?
- Calcium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2012to Aug 2012
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- recreationally active
- male
Who cannot join
- food intolerances/allergies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne on Wear, NE1 8ST
About this study
The purpose of this study is to investigate the appetite, insulin and incretin hormone responses to a high-calcium meal.
Read the detailed description
Participants will be provided with control and high-calcium meals. Insulin, appetite, glucagon-like peptide-1 and glucose-dependent insulinotropic peptide responses will be assessed, along with rates of substrate oxidation.
- Conditions
- Nutritional and Metabolic Diseases
- Being tested
- Calcium
- Medical subject headings
- Nutritional and Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalciumDietary supplement
Milk-calcium supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective appetite ratings
Subjective ratings of appetite assessed by visual analogue scales.
Measured: 3 hour
Secondary outcomes (3)
Serum insulin concentration
2 hour area under the curve for serum insulin following breakfast consumption
Measured: 2 hour
Plasma glucose-dependent insulinotropic peptide concentration
2 hour area under the curve for plasma glucose-dependent insulinotropic peptide following breakfast consumption
Measured: 2 hour
Plasma glucagon-like peptide-1 concentration
2 hour area under the curve for plasma glucagon-like peptide-1 following breakfast consumption
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseasesStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, Northumbria University
- Investigators
- Javier T Gonzalez, MRes, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682343
- Sponsor's protocol ID
- 32AN2
- Status last verified
- Sep 2012
- First submitted
- 6 Sep 2012
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-calcium Intake on Appetite, Insulinemia and Incretins
- ClinicalTrials.gov ID
- NCT01682343
- Acronym / sponsor ID
- 32AN2
- Conditions
- Nutritional and Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Sep 2012 (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 investigate the appetite, insulin and incretin hormone responses to a high-calcium meal.
Detailed description
Participants will be provided with control and high-calcium meals. Insulin, appetite, glucagon-like peptide-1 and glucose-dependent insulinotropic peptide responses will be assessed, along with rates of substrate oxidation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | –Breakfast consisting of milk-based porridge with a normal calcium content. |
| High-Calcium | Experimental | Dietary Supplement: CalciumAs control, but with a high-calcium content. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- recreationally active
- male
Key exclusion criteria (1 listed)
- food intolerances/allergies
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-calcium supplement | Dietary supplement | High-Calcium |
Primary outcome
Subjective appetite ratings
Time frame: 3 hour
Subjective ratings of appetite assessed by visual analogue scales.
3 secondary outcomes
Serum insulin concentration
Time frame: 2 hour
Plasma glucose-dependent insulinotropic peptide concentration
Time frame: 2 hour
Plasma glucagon-like peptide-1 concentration
Time frame: 2 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 11 Sep 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.
Javier T Gonzalez, MRes 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 Nutritional and Metabolic Diseases, 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 2 inclusion and 1 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 11 Sep 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?
Subjective appetite ratings (time frame: 3 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 11 Sep 2012.