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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: low fat yogurt enriched with flaxseed
* Dietary Supplement: low fat yogurt


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low fat yogurt enriched with flaxseed<br>200 gr low fat yogurt enriched with 30 gr flaxseed | Dietary Supplement: low fat yogurt enriched with flaxseed<br>* daily intake of low fat yogurt enriched with flaxseed for 8 weeks<br>|
| Placebo Comparator: low fat yogurt<br>200 gr low fat yogurt | Dietary Supplement: low fat yogurt<br>* daily intake of low fat yogurt for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in values of FBS at 8 week | FBS: Fasting blood sugar | 8 weeks | 
| Change from baseline in values of HbA1c at 8 week | HbA1C: glycosylated hemoglobin | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in values of weight at 8 week |  | 8 weeks | 
| Change from baseline in values of waist circumference at 8 week |  | 8 weeks | 
| Change from baseline in values of body mass index at 8 week |  | 8 weeks | 
| Change from baseline in values of blood pressure at 8 week | Blood pressure: systolic blood pressure, diastolic blood pressure | 8 weeks | 
| Change from baseline in values of Lipid profile (Total cholesterol, triglyceride, LDL-C, HDL-C) at 8 week | Lipid profile:Total cholesterol, triglyceride, LDL-C, HDL-C | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic patients, flaxseed, lipid profile, cardiovascular risc factors