Clinical trial NCT02436369: The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic Patients
Official title: The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetic patients
flaxseed
lipid profile
cardiovascular risc factors
Lead sponsor: Urmia University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in values of FBS at 8 week
timeFrame: 8 weeks
measure: Change from baseline in values of HbA1c at 8 week
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in values of weight at 8 week
timeFrame: 8 weeks
measure: Change from baseline in values of waist circumference at 8 week
timeFrame: 8 weeks
measure: Change from baseline in values of body mass index at 8 week
timeFrame: 8 weeks
measure: Change from baseline in values of blood pressure at 8 week
timeFrame: 8 weeks
measure: Change from baseline in values of Lipid profile (Total cholesterol, triglyceride, LDL-C, HDL-C) at 8 week
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Hasaniani N, Rahimlou M, Ramezani Ahmadi A, Mehdizadeh Khalifani A, Alizadeh M. The Effect of Flaxseed Enriched Yogurt on the Glycemic Status and Cardiovascular Risk Factors in Patients with Type 2 Diabetes Mellitus: Randomized, Open-labeled, Controlled Study. Clin Nutr Res. 2019 Oct 2;8(4):284-295. doi: 10.7762/cnr.2019.8.4.284. eCollection 2019 Oct.