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

Primary Purpose

Type 2 Diabetes Mellitus, Overweight

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dietary calcium supplementation
Control
Sponsored by
Federal University of Vicosa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Metabolism and body composition laboratory, Federal University of Vicosa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DAIRY

CONTROL

Arm Description

Dietary calcium supplementation

Control

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

Full Information

First Posted
February 25, 2015
Last Updated
February 3, 2018
Sponsor
Federal University of Vicosa
Collaborators
Fundação de Amparo à Pesquisa do estado de Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02377076
Brief Title
Dietary Calcium Supplementation, Gut Permeability and Microbiota in Type 2 Diabetics
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Vicosa
Collaborators
Fundação de Amparo à Pesquisa do estado de Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DAIRY
Arm Type
Experimental
Arm Description
Dietary calcium supplementation
Arm Title
CONTROL
Arm Type
Placebo Comparator
Arm Description
Control
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary calcium supplementation
Intervention Description
Dietary calcium supplementation as milk powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Control (Whey protein, vitamin D, sugar and salt)
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Metabolism and body composition laboratory, Federal University of Vicosa
City
Viçosa
State/Province
Minas Gerais
ZIP/Postal Code
36570-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
29498351
Citation
Gomes 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.
Results Reference
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Dietary Calcium Supplementation, Gut Permeability and Microbiota in Type 2 Diabetics

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