Dietary Calcium Supplementation, Gut Permeability and Microbiota in Type 2 Diabetics
1 other identifier
interventional
38
1 country
1
Brief 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. 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%).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes-mellitus
Started Sep 2014
Typical duration for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFebruary 6, 2018
February 1, 2018
1.8 years
February 25, 2015
February 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
3 months
Study Arms (2)
DAIRY
EXPERIMENTALDietary calcium supplementation
CONTROL
PLACEBO COMPARATORControl
Interventions
Dietary calcium supplementation as milk powder
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Metabolism and body composition laboratory, Federal University of Vicosa
Viçosa, Minas Gerais, 36570-000, Brazil
Related Publications (2)
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.
PMID: 38861793DERIVEDGomes 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.
PMID: 29498351DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
February 25, 2015
First Posted
March 3, 2015
Study Start
September 1, 2014
Primary Completion
June 1, 2016
Study Completion
March 1, 2017
Last Updated
February 6, 2018
Record last verified: 2018-02