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Completed

NCT Number: NCT02436369

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low fat yogurt enriched with flaxseed

Dietary Supplement

daily intake of low fat yogurt enriched with flaxseed for 8 weeks

low fat yogurt

Dietary Supplement

daily intake of low fat yogurt for 8 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Urmia University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
May 6, 2015
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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