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Effects of Low- or High-glycemic Index Diets on Metabolic and Inflammatory Responses in Diabetics

F

Federal University of Vicosa

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Dietary Supplement: High GI diet
Dietary Supplement: Low GI index diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02383784
40501156099

Details and patient eligibility

About

Background/Aims: Verify the effects of glycemic index (GI) on body composition, and on inflammatory and metabolic markers concentrations. Methods: Eighteen type 2 diabetics, (aged 42.4 + 5.1 years, BMI 29.2 + 4.8 kg.m-2) were randomly allocated to low GI (LGI) or high GI (HGI) groups. High or low GI meals were provided in the laboratory twice a day during 30 consecutive days. The other meals were consumed under free living condition and subjects were instructed to select foods presenting GI values corresponding to the allocated group. Body composition (body mass index, body fat percentage, waist circumference and waist-hip ratio), and inflammatory markers concentrations (interleukin-6, tumor necrosis factor-alpha, high molecular weight adiponectin, ultra-sensitive C-reactive protein and fibrinogen) and metabolic markers (glucose, insulin, total cholesterol, HDL cholesterol, free fatty acids, triglycerides and fructosamine) were assessed at baseline and after intervention. Food intake was monitored during the study. The criterion for statistical significance was P<0.05.

Enrollment

18 patients

Sex

All

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Type 2 diabetes mellitus
  • Level of physical activity light to moderate
  • Use of sulfonylureas or biguanides oral hypoglycemic drugs
  • Stable medications for the previous 3 months

Exclusion criteria

  • Cardiovascular, renal, or liver disease
  • Treatment for cancer
  • Smokers
  • Daily consumption of > 50g/day of alcohol
  • Pregnant, lactating, postmenopausal women,
  • Hormone replacement therapy
  • Recent change (last three months) in the level of physical activity or diet
  • Weight instability (> 3 kg in the previous three months),
  • Therapeutic diet
  • Allergies, test foods intolerance
  • Use of drugs affecting body metabolism and/or food intake.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

18 participants in 2 patient groups

Low-GI diet
Experimental group
Description:
Low glycemic index diet
Treatment:
Dietary Supplement: Low GI index diet
High-GI diet
Experimental group
Description:
High glycemic index diet
Treatment:
Dietary Supplement: High GI diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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