Diabetes MellitusNCT02436369
The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic Patients
A study testing low fat yogurt enriched with flaxseed and low fat yogurt in people with Diabetes Mellitus, run by Urmia University of Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- low fat yogurt enriched with flaxseed and low fat yogurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- low fat yogurt enriched with flaxseed, low fat yogurt
- Keywords
- diabetic patients, flaxseed, lipid profile, cardiovascular risc factors
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low fat yogurt enriched with flaxseedDietary supplement
daily intake of low fat yogurt enriched with flaxseed for 8 weeks
low fat yogurtDietary supplement
daily intake of low fat yogurt for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| low fat yogurt enriched with flaxseed | Experimental | 200 gr low fat yogurt enriched with 30 gr flaxseed Receives: Dietary Supplement: low fat yogurt enriched with flaxseed |
| low fat yogurt | Placebo comparator | 200 gr low fat yogurt Receives: Dietary Supplement: low fat yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in values of FBS at 8 week
FBS: Fasting blood sugar
Measured: 8 weeks
Change from baseline in values of HbA1c at 8 week
HbA1C: glycosylated hemoglobin
Measured: 8 weeks
Secondary outcomes (5)
Change from baseline in values of weight at 8 week
Measured: 8 weeks
Change from baseline in values of waist circumference at 8 week
Measured: 8 weeks
Change from baseline in values of body mass index at 8 week
Measured: 8 weeks
Change from baseline in values of blood pressure at 8 week
Blood pressure: systolic blood pressure, diastolic blood pressure
Measured: 8 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urmia University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436369
- Sponsor's protocol ID
- umsu.rec.1393.3
- Status last verified
- Apr 2015
- First submitted
- 19 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31720254
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic
- ClinicalTrials.gov ID
- NCT02436369
- Acronym / sponsor ID
- umsu.rec.1393.3
- Conditions
- Diabetes Mellitus
- Keywords
- diabetic patients, flaxseed, lipid profile, cardiovascular risc factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Urmia University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low fat yogurt enriched with flaxseed | Experimental | Dietary Supplement: low fat yogurt enriched with flaxseed200 gr low fat yogurt enriched with 30 gr flaxseed |
| low fat yogurt | Placebo comparator | Dietary Supplement: low fat yogurt200 gr low fat yogurt |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low fat yogurt enriched with flaxseeddaily intake of low fat yogurt enriched with flaxseed for 8 weeks | Dietary supplement | low fat yogurt enriched with flaxseed |
| low fat yogurtdaily intake of low fat yogurt for 8 weeks | Dietary supplement | low fat yogurt |
Primary outcome
Change from baseline in values of FBS at 8 week
Time frame: 8 weeks
FBS: Fasting blood sugar
Change from baseline in values of HbA1c at 8 week
Time frame: 8 weeks
HbA1C: glycosylated hemoglobin
5 secondary outcomes
Change from baseline in values of weight at 8 week
Time frame: 8 weeks
Change from baseline in values of waist circumference at 8 week
Time frame: 8 weeks
Change from baseline in values of body mass index at 8 week
Time frame: 8 weeks
Change from baseline in values of blood pressure at 8 week
Time frame: 8 weeks
Change from baseline in values of Lipid profile (Total cholesterol, triglyceride, LDL-C, HDL-C) at 8 week
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Derived from this study: PubMed 31720254Hasaniani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing low fat yogurt enriched with flaxseed and low fat yogurt in people with Diabetes Mellitus, run by Urmia University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in values of FBS at 8 week (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02436369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.