The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 70
- Primary Endpoint
- Change from baseline in values of FBS at 8 week
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
low fat yogurt enriched with flaxseed
200 gr low fat yogurt enriched with 30 gr flaxseed
Intervention: low fat yogurt enriched with flaxseed (Dietary Supplement)
low fat yogurt
200 gr low fat yogurt
Intervention: low fat yogurt (Dietary Supplement)
Outcomes
Primary Outcomes
Change from baseline in values of FBS at 8 week
Time Frame: 8 weeks
FBS: Fasting blood sugar
Change from baseline in values of HbA1c at 8 week
Time Frame: 8 weeks
HbA1C: glycosylated hemoglobin
Secondary Outcomes
- 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 blood pressure at 8 week(8 weeks)
- Change from baseline in values of waist circumference 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)