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

U

Urmia University of Medical Sciences

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Dietary Supplement: low fat yogurt enriched with flaxseed
Dietary Supplement: low fat yogurt

Study type

Interventional

Funder types

Other

Identifiers

NCT02436369
umsu.rec.1393.3

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups, including a placebo group

low fat yogurt enriched with flaxseed
Experimental group
Description:
200 gr low fat yogurt enriched with 30 gr flaxseed
Treatment:
Dietary Supplement: low fat yogurt enriched with flaxseed
low fat yogurt
Placebo Comparator group
Description:
200 gr low fat yogurt
Treatment:
Dietary Supplement: low fat yogurt

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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