The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic Patients

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Dietary Supplement: low fat yogurt enriched with flaxseed; Dietary Supplement: low fat yogurt

• Registration Number: NCT02436369
• Lead Sponsor: Urmia University of Medical Sciences

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 Timeline

• Study Start: 2014-09
• Primary Completion: 2014-11
• Study Completion: 2015-01
• Status Verified: 2015-04
• Study First Submitted: 2015-04-19
• Study First Submitted QC: 2015-05-03
• Last Update Submitted: 2015-05-03
• Study First Posted: 2015-05-06
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low fat yogurt enriched with flaxseed	low fat yogurt enriched with flaxseed	200 gr low fat yogurt enriched with 30 gr flaxseed
low fat yogurt	low fat yogurt	200 gr low fat yogurt

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Blood pressure: systolic blood pressure, diastolic blood pressure
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	Lipid profile:Total cholesterol, triglyceride, LDL-C, HDL-C