Dietary Calcium Supplementation, Gut Permeability and Microbiota in Type 2 Diabetics

February 3, 2018 updated by: Dr Junia Maria Geraldo Gomes, Federal University of Vicosa
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Viçosa, Minas Gerais, Brazil, 36570-000
        • Metabolism and body composition laboratory, Federal University of Vicosa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Use of anti-inflammatory, antacids, antibiotics and laxatives drugs
  • Major gastrointestinal surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: CONTROL
Control
Dietary supplement: Control
Control (Whey protein, vitamin D, sugar and salt)
Experimental: DAIRY
Dietary calcium supplementation
Dietary supplement: Dietary calcium supplementation
Dietary calcium supplementation as milk powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Vicosa

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do estado de Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 3, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 526.005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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