Lactose Intolerance. Metabolic Syndrome. Amplified Fragment Length Polymorphism Analysis. Polymorphism, Single Nucleotide
Conditions
Interventions
Three groups with different dietary interventions are compared:
CONTROL GROUP - Two hundrend patients will receive a hypocaloric dietary (with total energy value of 20 Kcal/kg weight), following the
Other
C06.405.469.637.506
Sponsors
Universidade do Estado da Bahia
Associação de Pais e Amigos dos Excepcionais (APAE)
Eligibility
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: Volunteers diagnosed with metabolic syndrome based on the criteria proposed by the International Diabetes Federation (IDF, 2006); both genders; age range from 20 to 80 years old; signature of the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, irritable colon and diverticulitis); with chronic renal failure; with chronic liver disease (with the exception of hepatic steatosis); taking medication for appetite control, hypoglycemic, hypolipidemic or anxiolytic/antidepressant; with autoimmune diseases and/or taking corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We aim to assess anthropometric parameters that compose and / or contribute to the development of metabolic syndrome. Anthropometric parameters will be verified by the presence of central obesity, from the measurement of abdominal circumference with the use of inelastic tape, considered appropriate when the measurements were less than 88cm for women and 94cm for men. This parameter will be verified according to the recommendations available in the I Brazilian Metabolic Syndrome Guideline of 2005. Continuous data will be presented as mean and standard deviation (or median and interquartile ranges) and categorical data with absolute and relative frequency. ;We aim to assess biochemical and clinical parameters that compose and / or contribute to the development of metabolic syndrome. The biochemical parameters will be verified by measuring the serum levels of: - high-density lipoprotein cholesterol (HDL-c), using the colorimetry method. Values are considered adequate when higher than 40 mg/dL in men or 50 mg/dL in women; - triglycerides, using the enzymatic method. Values are considered adequate when lower than 150mg/dL; - glucose, using the enzymatic method. Values are considered adequate between 70 to 99ml / dL. These parameters will be verified in patients after 12h fasting, using specific biomolecule dosing kits available at the laboratory of the Association of Parents and Friends of the Exceptional. The degree of insulin resistance will be evaluated using the Homeostasis Model Assessment Index (HOMA), the HOMA-IR. It is a simple mathematical calculation that is based on fasting insulin and glucose levels. In the following sentence, there is the formula for the calculation of HOMA-IR: Fasting blood glucose x 0.0555 x Fasting insulin / 22.5 (MATTHEWS et al., 1985; OLIVEIRA; SOUZA; LIMA, 2006). The insulin resistance classification was defined according to the instructions of the Brazilian Diabetes Society Guidelines (2015-2016), based on studies by Stern et al. | — |
Secondary
| Measure | Time frame |
|---|---|
| We aim to evaluate the presence of lactose intolerance in patients with metabolic syndrome. To verify whether the individual has lactose intolerance, the oral lactose tolerance test (OLTT) is performed. OLTT uses the biochemical blood glucose test; this test consists of dosing fasting blood glucose and after 30 and 60 minutes of intake of 50g lactose (dose for adult and elderly). If blood glucose after lactose ingestion does not increase more than 20 mg/dl of fasting glucose, lactose intolerance is present. Following the lactose-free diet by metabolic syndrome patients, it is expected to find improvement of lactose intolerance signs and symptoms: - abdominal discomfort and pain - flatulence - diarrhea - borborygmos Such signs and symptoms will be verified in the interview, when patients/volunteers return to the nutrition clinic after experimental period. The results will be expressed as absolute and relative frequencies. | — |
Countries
Brazil
Contacts
Public ContactEdilene Queiroz Araújo
Universidade do Estado da Bahia
Outcome results
None listed