ObesityNCT02137434
Calcium Over Postprandial Effects of Fatty Meal on Metabolism, Blood Pressure, Oxidative Stress, Endothelial Function.
A study testing Dietary calcium and Supplementary calcium in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The purpose of the study is to investigate calcium acute influence over the postprandial effects of a fatty meal on serum calcium, plasma glucose and triglycerides, blood pressure, oxidative stress, and endothelial function in obese women. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Dietary calcium and Supplementary calcium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2014to Dec 2015
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- body mass index (BMI) greater than or equal to 30 kg/m2 and below 40 kg/m2
- habitual dietary calcium intake below 500 mg per day
Who cannot join
- smoking
- dietary supplements or drugs that could interfere with body weight, metabolic profile and blood pressure
- diabetes
- thyroid dysfunction
- hypertension
- angina pectoris
Show all 17Show fewer
- heart kidney or liver failure
- intestinal malabsorption
- acute or chronic inflammation
- HIV infection
- autoimmune diseases
- cancer
- chronic obstructive pulmonary disease
- dyslipidemia with indication for drug treatment
- history of myocardial infarction or stroke
- pregnancy and lactation
- menopause
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Discipline of Clinical and Experimental Pathophysiology, Rio de Janeiro State University
Rio de Janeiro, Rio de Janeiro, 20551-030
Márcia G Torres, PhD., 55 21 23342063, marciarsimas@gmail.com
Thaís S Ferreira, MSc.
About this study
Official title: Influence of Dietary and Supplementary Calcium Over the Postprandial Effects of a Fatty Meal on Metabolism Profile, Blood Pressure, Oxidative Stress, and Endothelial Function of Obese Women.
The purpose of the study is to investigate calcium acute influence over the postprandial effects of a fatty meal on serum calcium, plasma glucose and triglycerides, blood pressure, oxidative stress, and endothelial function in obese women.
Read the detailed description
Studies suggest that dietary calcium intake is inversely associated with cardiovascular disease, but supplementary calcium appears to be associated with raised risk of cardiovascular events. Fatty meals lead to oxidative and inflammation which seems to interfere in postprandial dismetabolism, a predictor of cardiovascular events. To investigate calcium acute influence over the postprandial effects of a fatty meal a crossover, controlled, and randomized clinical trial will be conducted with obese adult women who will be randomized into one of the three interventions, characterized by a fatty meal with different contents of calcium: low calcium (40 mg), high dietary calcium (540 mg from non-fat milk), and high supplementary calcium (540 mg from calcium carbonate). Each participant will receive all three meals and one of them every week. Before meals' intake blood sample will be collected and endothelial function assess will be performed. Participants will eat the specific meal and endothelial function will be assessed again after 120 minutes. Blood sample collections will be repeated every 60 minutes after meal's intake to perform latter biochemical analyzes to determine: 8-isoprostane levels, to assess oxidative stress status; triglycerides; glucose; insulin; and serum calcium. Blood pressure will be continuously assessed during 25 minutes before meals' intake and during 2 hours after it.
- Conditions
- Obesity
- Being tested
- Dietary calcium, Supplementary calcium
- Keywords
- Acute calcium, Dietary calcium, Supplementary calcium, Postprandial metabolism
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary calciumOther
Dietary calcium from skimmed milk
Supplementary calciumDietary supplement
Supplementary calcium from calcium carbonate
| Study group | Role | What they receive |
|---|---|---|
| Low calcium fatty meal | Placebo comparator | Fatty meal consisting of biscuit, butter and drink made of albumin and sugar containing 40 mg of calcium, 600 kcal, with approximately 10% of energy from protein, 53% from fat, and 37% from carbohydrates. |
| High dietary calcium fatty meal | Experimental | Fatty meal consisting of biscuit, butter and drink made of skimmed milk containing 540 mg of dietary calcium, 600 kcal, with approximately 10% of energy from protein, 53% from fat, and 37% from carbohydrates. Receives: Other: Dietary calcium |
| High supplementary calcium fatty meal | Experimental | Fatty meal consisting of biscuit, butter and drink made of albumin and sugar containing 540 mg of supplementary calcium from calcium carbonate, 600 kcal, with approximately 10% of energy from protein, 53% from fat, and 37% from carbohydrates. Receives: Dietary Supplement: Supplementary calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Blood pressure will be assessed by digital photoplethysmography.
Measured: Blood pressure will be assessed continuously 25 min before meals' intake and 2 hours after it.
Secondary outcomes (1)
Endothelial function
Endothelial function will be assessed by laser doppler fluxometry.
Measured: Endothelial function will be assessed after meals' intake and 2 hours after it.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Antonio Felipe Sanjuliani, Rio de Janeiro State University
- Investigators
- Antonio F Sanjuliani, PhD., Principal investigator, Discipline of Clinical and Experimental Pathophysiology, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137434
- Sponsor's protocol ID
- Acute calcium
- Status last verified
- May 2014
- First submitted
- 9 May 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dietary and Supplementary Calcium Over the Postprandial Effects of a Fatty Meal on Metabolism Profile, Blood Pressure, Oxidative Stress, and Endothelial Function of Obese Women.
- ClinicalTrials.gov ID
- NCT02137434
- Acronym / sponsor ID
- Acute calcium
- Conditions
- Obesity
- Keywords
- Acute calcium, Dietary calcium, Supplementary calcium, Postprandial metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Feb 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 13 May 2014 (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 the study is to investigate calcium acute influence over the postprandial effects of a fatty meal on serum calcium, plasma glucose and triglycerides, blood pressure, oxidative stress, and endothelial function in obese women.
Detailed description
Studies suggest that dietary calcium intake is inversely associated with cardiovascular disease, but supplementary calcium appears to be associated with raised risk of cardiovascular events. Fatty meals lead to oxidative and inflammation which seems to interfere in postprandial dismetabolism, a predictor of cardiovascular events. To investigate calcium acute influence over the postprandial effects of a fatty meal a crossover, controlled, and randomized clinical trial will be conducted with obese adult women who will be randomized into one of the three interventions, characterized by a fatty meal with different contents of calcium: low calcium (40 mg), high dietary calcium (540 mg from non-fat milk), and high supplementary calcium (540 mg from calcium carbonate). Each participant will receive all three meals and one of them every week. Before meals' intake blood sample will be collected and endothelial function assess will be performed. Participants will eat the specific meal and endothelial function will be assessed again after 120 minutes. Blood sample collections will be repeated every 60 minutes after meal's intake to perform latter biochemical analyzes to determine: 8-isoprostane levels, to assess oxidative stress status; triglycerides; glucose; insulin; and serum calcium. Blood pressure will be continuously assessed during 25 minutes before meals' intake and during 2 hours after it.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low calcium fatty meal | Placebo comparator | –Fatty meal consisting of biscuit, butter and drink made of albumin and sugar containing 40 mg of calcium, 600 kcal, with approximately 10% of energy from protein, 53% from fat, and 37% from carbohydrates. |
| High dietary calcium fatty meal | Experimental | Other: Dietary calciumFatty meal consisting of biscuit, butter and drink made of skimmed milk containing 540 mg of dietary calcium, 600 kcal, with approximately 10% of energy from protein, 53% from fat, and 37% from carbohydrates. |
| High supplementary calcium fatty meal | Experimental | Dietary Supplement: Supplementary calciumFatty meal consisting of biscuit, butter and drink made of albumin and sugar containing 540 mg of supplementary calcium from calcium carbonate, 600 kcal, with approximately 10% of energy from protein, 53% from fat, and 37% from carbohydrates. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- body mass index (BMI) greater than or equal to 30 kg/m2 and below 40 kg/m2
- habitual dietary calcium intake below 500 mg per day
Key exclusion criteria (17 listed)
- smoking
- dietary supplements or drugs that could interfere with body weight, metabolic profile and blood pressure
- diabetes
- thyroid dysfunction
- hypertension
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 |
|---|---|---|
| Dietary calciumDietary calcium from skimmed milk | Other | High dietary calcium fatty meal |
| Supplementary calciumSupplementary calcium from calcium carbonate | Dietary supplement | High supplementary calcium fatty meal |
Primary outcome
Blood pressure
Time frame: Blood pressure will be assessed continuously 25 min before meals' intake and 2 hours after it.
Blood pressure will be assessed by digital photoplethysmography.
1 secondary outcome
Endothelial function
Time frame: Endothelial function will be assessed after meals' intake and 2 hours after it.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Antonio F Sanjuliani, PhD. principal investigator
Discipline of Clinical and Experimental Pathophysiology, Rio de Janeiro State 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 Dietary calcium and Supplementary calcium in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
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 17 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: status not confirmed, as of the sponsor's last update on 13 May 2014. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thaís S Ferreira, MSc. (55 21 2334-2063, thaissferreira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Blood pressure will be assessed continuously 25 min before meals' intake and 2 hours after it.). 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 13 May 2014.