Metabolic SyndromeNCT03734835
The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome
A study testing hesperidin, hesperidin and flaxseed and flaxseed in people with Metabolic Syndrome, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial summary
To study the effects of Hesperidin, flaxseed and both together in patients with metabolic syndrome, 100 patients will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- hesperidin, hesperidin and flaxseed and flaxseed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- 1 Apr 2018to 1 Mar 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 to 70 years
- having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HD
Who cannot join
- pregnancy or lactation
- history of Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
- Following a program to lose weight in recent 3 mo
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
National Nutrition and Food Technology Research Institute
Tehran, Iran (the Islamic Republic Of), 1981619573
Azits Hekmatdoost, MD,PhD, +982122357484
About this study
Official title: The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome and Its Components: A Randomized, Controlled Study
To study the effects of Hesperidin, flaxseed and both together in patients with metabolic syndrome, 100 patients will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, metabolic factors will be assessed and compared between groups.
- Conditions
- Metabolic Syndrome
- Being tested
- hesperidin, hesperidin and flaxseed, flaxseed, control
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hesperidinDietary supplement
1000 mg hesperidin as two capsules
hesperidin and flaxseedDietary supplement
1000 mg hesperidin as two capsules and 30 grams flaxseed
flaxseedDietary supplement
30 grams flaxseed
controlOther
no supplementation
| Study group | Role | What they receive |
|---|---|---|
| hesperidin and flaxseed | Active comparator | 1000 mg hesperidin as two capsules and 30 grams flaxseed Receives: Dietary Supplement: hesperidin and flaxseed |
| control | Placebo comparator | no supplementation Receives: Other: control |
| flaxseed | Active comparator | 30 grams flaxseed Receives: Dietary Supplement: flaxseed |
| hesperidin | Active comparator | 1000 mg hesperidin as two capsules Receives: Dietary Supplement: hesperidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome: Number of participants with treated metabolic syndrome
Number of participants with treated metabolic syndrome
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Apr 2018
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734835
- Sponsor's protocol ID
- 13678
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome and Its Components: A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03734835
- Acronym / sponsor ID
- 13678
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 8 Nov 2018 (actual)
- 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.
To study the effects of Hesperidin, flaxseed and both together in patients with metabolic syndrome, 100 patients will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, metabolic factors will be assessed and compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| hesperidin and flaxseed | Active comparator | Dietary Supplement: hesperidin and flaxseed1000 mg hesperidin as two capsules and 30 grams flaxseed |
| control | Placebo comparator | Other: controlno supplementation |
| flaxseed | Active comparator | Dietary Supplement: flaxseed30 grams flaxseed |
| hesperidin | Active comparator | Dietary Supplement: hesperidin1000 mg hesperidin as two capsules |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 18 to 70 years
- having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HD
Key exclusion criteria (3 listed)
- pregnancy or lactation
- history of Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
- Following a program to lose weight in recent 3 mo
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 |
|---|---|---|
| hesperidin1000 mg hesperidin as two capsules | Dietary supplement | hesperidin |
| hesperidin and flaxseed1000 mg hesperidin as two capsules and 30 grams flaxseed | Dietary supplement | hesperidin and flaxseed |
| flaxseed30 grams flaxseed | Dietary supplement | flaxseed |
| controlno supplementation | Other | control |
Primary outcome
Metabolic syndrome: Number of participants with treated metabolic syndrome
Time frame: 12 weeks
Number of participants with treated metabolic syndrome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hesperidin, hesperidin and flaxseed and flaxseed in people with Metabolic Syndrome, run by National Nutrition and Food Technology Institute at 1 site in Iran.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact azita Hekmatdoost, MD.PhD (+982122357484, a_hekmat2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome: Number of participants with treated metabolic syndrome (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.