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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377076
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Dr Junia Maria Geraldo Gomes, Federal University of Vicosa

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%).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Overweight Dietary Supplement: Dietary calcium supplementation Dietary Supplement: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : September 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: DAIRY
Dietary calcium supplementation
Dietary Supplement: Dietary calcium supplementation
Dietary calcium supplementation as milk powder

Placebo Comparator: CONTROL
Control
Dietary Supplement: Control
Control (Whey protein, vitamin D, sugar and salt)




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377076


Locations
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Brazil
Metabolism and body composition laboratory, Federal University of Vicosa
Viçosa, Minas Gerais, Brazil, 36570-000
Sponsors and Collaborators
Federal University of Vicosa
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Junia Maria Geraldo Gomes, Dr, Federal University of Vicosa
ClinicalTrials.gov Identifier: NCT02377076    
Other Study ID Numbers: 526.005
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms
Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents