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

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ClinicalTrials.gov Identifier: NCT02436369
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Dietary Supplement: low fat yogurt enriched with flaxseed Dietary Supplement: low fat yogurt Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic
Study Start Date : September 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: low fat yogurt enriched with flaxseed
200 gr low fat yogurt enriched with 30 gr flaxseed
Dietary Supplement: low fat yogurt enriched with flaxseed
daily intake of low fat yogurt enriched with flaxseed for 8 weeks

Placebo Comparator: low fat yogurt
200 gr low fat yogurt
Dietary Supplement: low fat yogurt
daily intake of low fat yogurt for 8 weeks




Primary Outcome Measures :
  1. Change from baseline in values of FBS at 8 week [ Time Frame: 8 weeks ]
    FBS: Fasting blood sugar

  2. Change from baseline in values of HbA1c at 8 week [ Time Frame: 8 weeks ]
    HbA1C: glycosylated hemoglobin


Secondary Outcome Measures :
  1. Change from baseline in values of weight at 8 week [ Time Frame: 8 weeks ]
  2. Change from baseline in values of waist circumference at 8 week [ Time Frame: 8 weeks ]
  3. Change from baseline in values of body mass index at 8 week [ Time Frame: 8 weeks ]
  4. Change from baseline in values of blood pressure at 8 week [ Time Frame: 8 weeks ]
    Blood pressure: systolic blood pressure, diastolic blood pressure

  5. Change from baseline in values of Lipid profile (Total cholesterol, triglyceride, LDL-C, HDL-C) at 8 week [ Time Frame: 8 weeks ]
    Lipid profile:Total cholesterol, triglyceride, LDL-C, HDL-C



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Urmia University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02436369     History of Changes
Other Study ID Numbers: umsu.rec.1393.3
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: April 2015

Keywords provided by Urmia University of Medical Sciences:
diabetic patients
flaxseed
lipid profile
cardiovascular risc factors

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases