Diabetes Mellitus
Conditions
Keywords
diabetic patients, flaxseed, lipid profile, cardiovascular risc factors
Brief summary
The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel randomized controlled trial the investigators recruited 70 diabetic patients and randomly allocated to control and treatment groups. Participants in treatment group consumed 30 gr flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily. Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood pressure, weight, waist circumference and body mass index were measured at the first and end of the trial.
Detailed description
Nutritionists have concern about consumption of full fat dairy in diabetic patients due to their content of saturated fatty acids. The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel randomized controlled trial the investigators recruited 70 diabetic patients and randomly allocated to control and treatment groups. Participants in treatment group consumed 30 gr flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily. Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood pressure, weight, waist circumference and body mass index were measured at the first and end of the trial.
Interventions
DIETARY_SUPPLEMENTlow fat yogurt enriched with flaxseed
daily intake of low fat yogurt enriched with flaxseed for 8 weeks
DIETARY_SUPPLEMENTlow fat yogurt
daily intake of low fat yogurt for 8 weeks
Sponsors
Urmia University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BMI between 20 and 35 kg/m2 - * treated with oral hypoglycemic agents (Metformin or Glibenclamide) * no use of insulin * fasting blood glucose≥ 126 (but less than 400 mg/dl)or 2 hours blood sugar ≤ 200 mg/dl * no pregnancy and lactation * Blood lipids and blood pressure-lowering agents must remained unalteredwithin the last 3 months.
Exclusion criteria
* Participants were excluded if they smoked, used alcohol, took dietary supplements containing Omega 3, phytoestrogens, antioxidants and fiber regularly, had been diagnosed with GI disease or renal, liver, cancer , inflammatory disease, had food allergies or intolerances
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in values of FBS at 8 week | 8 weeks | FBS: Fasting blood sugar |
| Change from baseline in values of HbA1c at 8 week | 8 weeks | HbA1C: glycosylated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in values of body mass index at 8 week | 8 weeks | — |
| Change from baseline in values of weight at 8 week | 8 weeks | — |
| Change from baseline in values of Lipid profile (Total cholesterol, triglyceride, LDL-C, HDL-C) at 8 week | 8 weeks | Lipid profile:Total cholesterol, triglyceride, LDL-C, HDL-C |
| Change from baseline in values of blood pressure at 8 week | 8 weeks | Blood pressure: systolic blood pressure, diastolic blood pressure |
| Change from baseline in values of waist circumference at 8 week | 8 weeks | — |
Outcome results
None listed