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

NCT ID: NCT02377076

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-03-31

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%).

Conditions

Type 2 Diabetes Mellitus; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DAIRY

Dietary calcium supplementation

Group Type: EXPERIMENTAL

Dietary calcium supplementation

Intervention Type: DIETARY_SUPPLEMENT

Dietary calcium supplementation as milk powder

CONTROL

Control

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Dietary calcium supplementation

Dietary calcium supplementation as milk powder

Intervention Type: DIETARY_SUPPLEMENT

Control

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Federal University of Vicosa

OTHER

Sponsor Role: lead

Responsible Party

Dr Junia Maria Geraldo Gomes

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Metabolism and body composition laboratory, Federal University of Vicosa

Viçosa, Minas Gerais, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 38861793 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29498351 (View on PubMed)

Other Identifiers

526.005

Identifier Type: -

Identifier Source: org_study_id