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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436369
• Other study ID #: umsu.rec.1393.3
• Status: Completed
• Phase: N/A
• First received: April 19, 2015
• Last updated: May 3, 2015
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Urmia University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iraq: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Dietary Supplement:
• low fat yogurt enriched with flaxseed
daily intake of low fat yogurt enriched with flaxseed for 8 weeks
• low fat yogurt
daily intake of low fat yogurt for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Urmia University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in values of FBS at 8 week	FBS: Fasting blood sugar	8 weeks	No
Primary	Change from baseline in values of HbA1c at 8 week	HbA1C: glycosylated hemoglobin	8 weeks	No
Secondary	Change from baseline in values of weight at 8 week		8 weeks	No
Secondary	Change from baseline in values of waist circumference at 8 week		8 weeks	No
Secondary	Change from baseline in values of body mass index at 8 week		8 weeks	No
Secondary	Change from baseline in values of blood pressure at 8 week	Blood pressure: systolic blood pressure, diastolic blood pressure	8 weeks	No
Secondary	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	No