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

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%).

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metabolism and body composition laboratory, Federal University of Vicosa

Viçosa, Minas Gerais, 36570-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary calcium supplementation

Dietary Supplement

Dietary calcium supplementation as milk powder

Control

Dietary Supplement

Control (Whey protein, vitamin D, sugar and salt)

Primary outcomes

HbA1c

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Federal University of Vicosa

Other

Collaborators

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

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Mar 3, 2015
Registry last updated: Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed