Type 2 Diabetes MellitusNCT02377076
Dietary Calcium Supplementation, Gut Permeability and Microbiota in Type 2 Diabetics
A study testing Dietary calcium supplementation in people with Type 2 Diabetes Mellitus and Overweight, run by Federal University of Vicosa at 1 site in Brazil.
Trial summary
Dietary calcium seems to act on glycemic control, favoring the prevention and treatment of type 2 diabetes mellitus (DM2). It is possible that calcium modulates gut microbiota and increase the integrity of the intestinal mucosa. Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Overweight
- What is being tested?
- Dietary calcium supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Mar 2017
- 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 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 diabetes mellitus using oral hypoglycemic medication
- Overweight (body mass index between 25 and 34.9 kg / m2)
- Usual intake of calcium less than 600 mg / day
- Level of physical activity light to moderate
- HbA1c above 7% or fasting glucose above 130 mg / dl
Who cannot join
- Smoking
- Use of calcium, vitamin D, magnesium, zinc, chromium, copper supplements or medication affecting the metabolism of these micronutrients,
- Use of drugs, herbs or diets that reduce appetite and body weight
- Estrogen replacement
- Gain or loss of at least 5 kg in the last 3 months
- Recent change in the level of physical activity
Show all 17Show fewer
- Aversion or intolerance to food provided in the study
- Alcohol consumption of more than 2 doses / day (more than 50g ethanol / day)
- Eating disorders
- Endocrine disease, renal disease, hepatic disease or malabsorption syndrome that alters calcium metabolism
- History of recurrent nephrolithiasis
- Caffeine consumption of> 300 mg / day
- Pregnancy, lactation or postmenopausal
- Anemia
- Cardiovascular, infectious, inflammatory, thyroid, liver, kidney or intestinal disease
- Use of anti-inflammatory, antacids, antibiotics and laxatives drugs
- Major gastrointestinal surgery.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Metabolism and body composition laboratory, Federal University of Vicosa
Viçosa, Minas Gerais, 36570-000
About this study
Dietary calcium seems to act on glycemic control, favoring the prevention and treatment of type 2 diabetes mellitus (DM2). It is possible that calcium modulates gut microbiota and increase the integrity of the intestinal mucosa. This study aims to evaluate the effects of dietary calcium supplementation in permeability and intestinal microbiota in overweight type 2 diabetics. This is a single-blind, randomized, placebo-controlled, crossover study. Patients (n=20) with low habitual calcium intake will be allocated in control group (CONTROL) or test group (DAIRY). Hypocaloric diets (restriction of 500 kcal / day) will be prescribed containing 800 mg of calcium from dietary sources / day. During intervention period, a beverage (shake) (CONTROL - without the addition of calcium sources or DAIRY - 700 mg of calcium as milk powder) will be ingested in the laboratory. Food intake, body composition (total body fat and fat free mass) and anthropometric measures (waist circumference, waist-hip ratio, waist-height, neck circumference and sagittal abdominal diameter) will be evaluated at baseline and at the 6th and 12th weeks. Physical activity level, gut permeability, gut microbiota, and biochemical parameters (parathyroid hormone, 25-dihydroxy vitamin D, calcium, fasting glucose, fasting insulin, fructosamine, hemoglobin, HbA1c, uric acid, triglycerides, cholesterol total and partial, lipopolysaccharide, inflammatory markers) will be evaluated at baseline and after 12 weeks. The statistical analysis will be performed with the use of SPSS software (SPSS Inc., Chicago, IL, 2008, version 17.0). Parametric or non-parametric tests will be applied, according to the distribution of variables (level of statistical significance of 5%).
- Conditions
- Type 2 Diabetes Mellitus, Overweight
- Being tested
- Dietary calcium supplementation, Control
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary calcium supplementationDietary supplement
Dietary calcium supplementation as milk powder
ControlDietary supplement
Control (Whey protein, vitamin D, sugar and salt)
| Study group | Role | What they receive |
|---|---|---|
| DAIRY | Experimental | Dietary calcium supplementation Receives: Dietary Supplement: Dietary calcium supplementation |
| CONTROL | Placebo comparator | Control Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Vicosa
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Dr Junia Maria Geraldo Gomes, Federal University of Vicosa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377076
- Sponsor's protocol ID
- 526.005
- Status last verified
- Feb 2018
- First submitted
- 25 Feb 2015
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Oliveira JSE, Gomes JMG, Costa JA, Oliveira LL, Alfenas RCG. Increased calcium intake from skimmed milk in energy-restricted diets reduces glycation markers in adults with type 2 diabetes and overweight: A secondary analysis of a randomized clinical trial. Nutr Res. 2024 Jul;127:40-52. doi: 10.1016/j.nutres.2024.04.008. Epub 2024 May 2.
PubMed 38861793Gomes JMG, Costa JDA, Alfenas RCG. Effect of increased calcium consumption from fat-free milk in an energy-restricted diet on the metabolic syndrome and cardiometabolic outcomes in adults with type 2 diabetes mellitus: a randomised cross-over clinical trial. Br J Nutr. 2018 Feb;119(4):422-430. doi: 10.1017/S0007114517003956.
PubMed 29498351
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Calcium Supplementation, Gut Permeability and Microbiota in Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT02377076
- Acronym / sponsor ID
- 526.005
- Conditions
- Type 2 Diabetes Mellitus, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Federal University of VicosaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 3 Mar 2015 (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.
Dietary calcium seems to act on glycemic control, favoring the prevention and treatment of type 2 diabetes mellitus (DM2). It is possible that calcium modulates gut microbiota and increase the integrity of the intestinal mucosa. This study aims to evaluate the effects of dietary calcium supplementation in permeability and intestinal microbiota in overweight type 2 diabetics. This is a single-blind, randomized, placebo-controlled, crossover study. Patients (n=20) with low habitual calcium intake will be allocated in control group (CONTROL) or test group (DAIRY). Hypocaloric diets (restriction of 500 kcal / day) will be prescribed containing 800 mg of calcium from dietary sources / day. During intervention period, a beverage (shake) (CONTROL - without the addition of calcium sources or DAIRY - 700 mg of calcium as milk powder) will be ingested in the laboratory. Food intake, body composition (total body fat and fat free mass) and anthropometric measures (waist circumference, waist-hip ratio, waist-height, neck circumference and sagittal abdominal diameter) will be evaluated at baseline and at the 6th and 12th weeks. Physical activity level, gut permeability, gut microbiota, and biochemical parameters (parathyroid hormone, 25-dihydroxy vitamin D, calcium, fasting glucose, fasting insulin, fructosamine, hemoglobin, HbA1c, uric acid, triglycerides, cholesterol total and partial, lipopolysaccharide, inflammatory markers) will be evaluated at baseline and after 12 weeks. The statistical analysis will be performed with the use of SPSS software (SPSS Inc., Chicago, IL, 2008, version 17.0). Parametric or non-parametric tests will be applied, according to the distribution of variables (level of statistical significance of 5%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAIRY | Experimental | Dietary Supplement: Dietary calcium supplementationDietary calcium supplementation |
| CONTROL | Placebo comparator | Dietary Supplement: ControlControl |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus using oral hypoglycemic medication
- Overweight (body mass index between 25 and 34.9 kg / m2)
- Usual intake of calcium less than 600 mg / day
- Level of physical activity light to moderate
- HbA1c above 7% or fasting glucose above 130 mg / dl
Key exclusion criteria (17 listed)
- Smoking
- Use of calcium, vitamin D, magnesium, zinc, chromium, copper supplements or medication affecting the metabolism of these micronutrients,
- Use of drugs, herbs or diets that reduce appetite and body weight
- Estrogen replacement
- Gain or loss of at least 5 kg in the last 3 months
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 calcium supplementationDietary calcium supplementation as milk powder | Dietary supplement | DAIRY |
| ControlControl (Whey protein, vitamin D, sugar and salt) | Dietary supplement | CONTROL |
Primary outcome
HbA1c
Time frame: 3 months
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 Feb 2018.
- Derived from this study: PubMed 38861793Oliveira JSE, Gomes JMG, Costa JA, Oliveira LL, Alfenas RCG. Increased calcium intake from skimmed milk in energy-restricted diets reduces glycation markers in adults with type 2 diabetes and overweight: A secondary analysis of a randomized clinical trial. Nutr Res. 2024 Jul;127:40-52. doi: 10.1016/j.nutres.2024.04.008. Epub 2024 May 2.
- Derived from this study: PubMed 29498351Gomes JMG, Costa JDA, Alfenas RCG. Effect of increased calcium consumption from fat-free milk in an energy-restricted diet on the metabolic syndrome and cardiometabolic outcomes in adults with type 2 diabetes mellitus: a randomised cross-over clinical trial. Br J Nutr. 2018 Feb;119(4):422-430. doi: 10.1017/S0007114517003956.
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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 Dietary calcium supplementation in people with Type 2 Diabetes Mellitus and Overweight, run by Federal University of Vicosa 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 5 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: finished, as of the sponsor's last update on 6 Feb 2018. 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?
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?
HbA1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02377076, which also lists 2 linked publications.
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 Feb 2018.