NCT02436369

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
Last Updated

May 6, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

April 19, 2015

Last Update Submit

May 3, 2015

Conditions

Diabetes Mellitus

Keywords

diabetic patientsflaxseedlipid profilecardiovascular risc factors

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in values of FBS at 8 week

    FBS: Fasting blood sugar

    8 weeks

  • Change from baseline in values of HbA1c at 8 week

    HbA1C: glycosylated hemoglobin

    8 weeks

Secondary Outcomes (5)

  • Change from baseline in values of weight at 8 week

    8 weeks

  • Change from baseline in values of waist circumference at 8 week

    8 weeks

  • Change from baseline in values of body mass index at 8 week

    8 weeks

  • Change from baseline in values of blood pressure at 8 week

    8 weeks

  • Change from baseline in values of Lipid profile (Total cholesterol, triglyceride, LDL-C, HDL-C) at 8 week

    8 weeks

Study Arms (2)

low fat yogurt enriched with flaxseed

EXPERIMENTAL

200 gr low fat yogurt enriched with 30 gr flaxseed

Dietary Supplement: low fat yogurt enriched with flaxseed

low fat yogurt

PLACEBO COMPARATOR

200 gr low fat yogurt

Dietary Supplement: low fat yogurt

Interventions

low fat yogurt enriched with flaxseedDIETARY_SUPPLEMENT

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

low fat yogurt enriched with flaxseed
low fat yogurtDIETARY_SUPPLEMENT

daily intake of low fat yogurt for 8 weeks

low fat yogurt

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31720254DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2015

First Posted

May 6, 2015

Study Start

September 1, 2014

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

May 6, 2015

Record last verified: 2015-04