Non-hodgkin LymphomaLymphoseedNCT03260231
Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma
A study testing Milled seed mix in people with Non-hodgkin Lymphoma, run by University of Belgrade at 1 site in Serbia.
Trial summary
Recent literature data suggest beneficial effects of dietary fats in patients with cancers, in particular polyunsaturated fatty acids (PUFAs). Milled mix of flax, sesame and pumpkin seeds provides a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Non-hodgkin Lymphoma
- What is being tested?
- Milled seed mix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSerbia
- Study dates
- 12 May 2017to 31 Dec 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed Non-Hodgkin lymphoma
- Patients able to understand requirements of the study and provide written informed consent
Who cannot join
- Previous radio- or chemotherapy
- Other serious chronic diseases
- Statin therapy
- Presence of allergy on any seeds
- Use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3 months prior to study
Trial locations and contacts
1 site in 1 country.
Snjezana Petrovic, PhD contact
Serbia1 site, 1 recruiting
- Recruiting
Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
Belgrade, 11129
Vesna Vucic, PhD, +381113031997, vesna.vucic.imr@gmail.com
Danijela Ristic Medic, MD PhD
About this study
Official title: Effects of Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma
Recent literature data suggest beneficial effects of dietary fats in patients with cancers, in particular polyunsaturated fatty acids (PUFAs). Milled mix of flax, sesame and pumpkin seeds provides a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio.
Read the detailed description
Cancers are characterized by inflammation and alternations in lipid and fatty acid metabolism. Patients with non-Hodgkin lymphoma have impaired fatty acid profiles, low level of PUFAs, and high n-6/n-3 PUFAs ratio. Moreover, these changes are related to clinical outcome.
Flax seeds, sesame and pumpkin seeds are rich sources of PUFAs. Dietary intake of milled mix of these seeds has been shown to decrease inflammation and improve PUFAs status in patients on hemodialysis and to decrease breast cancer risk.
The study design is single-blind, controlled, randomized nutritional intervention. The participants are randomly assigned into intervention and control group before starting chemotherapy. All patients receive nutritional counseling to achieve a daily energy and protein intake according to recommended dietary allowances, with (intervention) or without (control) of milled seed mix.
- Conditions
- Non-hodgkin Lymphoma
- Being tested
- Milled seed mix
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milled seed mixDietary supplement
Dietary intervention with or without seed mix
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Dietary Supplement: Milled Seed Mix Intervention arm includes milled mix of flax, sesame and pumpkin seeds (18/6/6 g) in sour milk taken as dietary replacement meal during the day, and between lunch and dinner. Seeds are provided with the same producer at the Belgrade market. Receives: Dietary Supplement: Milled seed mix |
| Control group | No intervention | No supplement Control arm includes nutritional counseling with a similar dietary regime as for the intervention arm, but without milled seed mix. patients were instructed to avoid plant seeds during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease status
Remission, stable disease or progression
Measured: Baseline, 5 months, 1 year
Change in quality of life questionnaire scores
Assessed by standardized questionnaires
Measured: Baseline, 5 months, 1 year
Secondary outcomes (7)
Changes in body weight
Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint
Measured: Baseline, 5 months, 1 year
Changes in leukocyte count
Measures of leukocyte count
Measured: Baseline, 5 months, 1 year
Changes in lipid profiles
Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint
Measured: Baseline, 5 months, 1 year
Changes in plasma fatty acids
Changes in plasma fatty acids profiles from baseline to endpoint
Measured: Baseline, 5 months, 1 year
Changes in CRP
Changes in CRP from baseline to endpoint
Measured: Baseline, 5 months, 1 year
Changes in interleukin (IL)-6
Changes in interleukin (IL)-6 from baseline to endpoint
Measured: Baseline, 5 months, 1 year
Changes in parameters of oxidative stress
Measures of activities of the following enzymes: SOD, catalase, glutathion peroxidase and glutation reductase
Measured: Baseline, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start12 May 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-hodgkin LymphomaStudies 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
- Model description
- This study is a parallel, randomized, single blind, controlled, 5-months nutritional intervention, investigating health effects of dietary intake of milled mix of flax/sesame pumpkin seeds in sour milk, in patients with NHL undergoing chemotherapy. At the beginning of the study, all patients received nutritional counselling, where half of the study subjects are randomly assigned to a treatment arm with milled seed mix consumption, or control arm without seed mix. Treatment arm is provided with 450g of milled seed mix and instructed to consume 30g of the mix daily (18g flax seed, 6g pumpkin seeds, and 6 g sesame) in 180 mL of sour milk. Control arm is instructed to consume180 mL of sour milk.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesna Vucic, University of Belgrade
- Investigators
- Vesna Vucic, PhD, Principal investigator, Institute for medical research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260231
- Sponsor's protocol ID
- 145/1
- Acronym
- Lymphoseed
- Status last verified
- Mar 2020
- First submitted
- 11 Aug 2017
- Last updated
- 20 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cvetkovic Z, Milosevic M, Cvetkovic B, Masnikosa R, Arsic A, Petrovic S, Vucic V. Plasma phospholipid changes are associated with response to chemotherapy in non-Hodgkin lymphoma patients. Leuk Res. 2017 Mar;54:39-46. doi: 10.1016/j.leukres.2017.01.004. Epub 2017 Jan 5.
PubMed 28107691Cvetkovic Z, Vucic V, Cvetkovic B, Petrovic M, Ristic-Medic D, Tepsic J, Glibetic M. Abnormal fatty acid distribution of the serum phospholipids of patients with non-Hodgkin lymphoma. Ann Hematol. 2010 Aug;89(8):775-82. doi: 10.1007/s00277-010-0904-6. Epub 2010 Feb 3.
PubMed 20127484Ristic-Medic D, Perunicic-Pekovic G, Rasic-Milutinovic Z, Takic M, Popovic T, Arsic A, Glibetic M. Effects of dietary milled seed mixture on fatty acid status and inflammatory markers in patients on hemodialysis. ScientificWorldJournal. 2014 Jan 22;2014:563576. doi: 10.1155/2014/563576. eCollection 2014.
PubMed 24578648
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT03260231
- Acronym / sponsor ID
- Lymphoseed / 145/1
- Conditions
- Non-hodgkin Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Aug 2017 (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.
Recent literature data suggest beneficial effects of dietary fats in patients with cancers, in particular polyunsaturated fatty acids (PUFAs). Milled mix of flax, sesame and pumpkin seeds provides a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio.
Detailed description
Cancers are characterized by inflammation and alternations in lipid and fatty acid metabolism. Patients with non-Hodgkin lymphoma have impaired fatty acid profiles, low level of PUFAs, and high n-6/n-3 PUFAs ratio. Moreover, these changes are related to clinical outcome.
Flax seeds, sesame and pumpkin seeds are rich sources of PUFAs. Dietary intake of milled mix of these seeds has been shown to decrease inflammation and improve PUFAs status in patients on hemodialysis and to decrease breast cancer risk.
The study design is single-blind, controlled, randomized nutritional intervention. The participants are randomly assigned into intervention and control group before starting chemotherapy. All patients receive nutritional counseling to achieve a daily energy and protein intake according to recommended dietary allowances, with (intervention) or without (control) of milled seed mix.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- This study is a parallel, randomized, single blind, controlled, 5-months nutritional intervention, investigating health effects of dietary intake of milled mix of flax/sesame pumpkin seeds in sour milk, in patients with NHL undergoing chemotherapy. At the beginning of the study, all patients received nutritional counselling, where half of the study subjects are randomly assigned to a treatment arm with milled seed mix consumption, or control arm without seed mix. Treatment arm is provided with 450g of milled seed mix and instructed to consume 30g of the mix daily (18g flax seed, 6g pumpkin seeds, and 6 g sesame) in 180 mL of sour milk. Control arm is instructed to consume180 mL of sour milk.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Dietary Supplement: Milled seed mixDietary Supplement: Milled Seed Mix Intervention arm includes milled mix of flax, sesame and pumpkin seeds (18/6/6 g) in sour milk taken as dietary replacement meal during the day, and between lunch and dinner. Seeds are provided with the same producer at the Belgrade market. |
| Control group | No intervention | –No supplement Control arm includes nutritional counseling with a similar dietary regime as for the intervention arm, but without milled seed mix. patients were instructed to avoid plant seeds during the study. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically confirmed Non-Hodgkin lymphoma
- Patients able to understand requirements of the study and provide written informed consent
Key exclusion criteria (5 listed)
- Previous radio- or chemotherapy
- Other serious chronic diseases
- Statin therapy
- Presence of allergy on any seeds
- Use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3 months prior to study
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 |
|---|---|---|
| Milled seed mixDietary intervention with or without seed mix | Dietary supplement | Intervention group |
Primary outcome
Change in disease status
Time frame: Baseline, 5 months, 1 year
Remission, stable disease or progression
Change in quality of life questionnaire scores
Time frame: Baseline, 5 months, 1 year
Assessed by standardized questionnaires
7 secondary outcomes
Changes in body weight
Time frame: Baseline, 5 months, 1 year
Changes in leukocyte count
Time frame: Baseline, 5 months, 1 year
Changes in lipid profiles
Time frame: Baseline, 5 months, 1 year
Changes in plasma fatty acids
Time frame: Baseline, 5 months, 1 year
Changes in CRP
Time frame: Baseline, 5 months, 1 year
Changes in interleukin (IL)-6
Time frame: Baseline, 5 months, 1 year
Changes in parameters of oxidative stress
Time frame: Baseline, 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Background: PubMed 28107691Cvetkovic Z, Milosevic M, Cvetkovic B, Masnikosa R, Arsic A, Petrovic S, Vucic V. Plasma phospholipid changes are associated with response to chemotherapy in non-Hodgkin lymphoma patients. Leuk Res. 2017 Mar;54:39-46. doi: 10.1016/j.leukres.2017.01.004. Epub 2017 Jan 5.
- Background: PubMed 20127484Cvetkovic Z, Vucic V, Cvetkovic B, Petrovic M, Ristic-Medic D, Tepsic J, Glibetic M. Abnormal fatty acid distribution of the serum phospholipids of patients with non-Hodgkin lymphoma. Ann Hematol. 2010 Aug;89(8):775-82. doi: 10.1007/s00277-010-0904-6. Epub 2010 Feb 3.
- Background: PubMed 24578648Ristic-Medic D, Perunicic-Pekovic G, Rasic-Milutinovic Z, Takic M, Popovic T, Arsic A, Glibetic M. Effects of dietary milled seed mixture on fatty acid status and inflammatory markers in patients on hemodialysis. ScientificWorldJournal. 2014 Jan 22;2014:563576. doi: 10.1155/2014/563576. eCollection 2014.
- Individual participant dataSharing planned: No
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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.
Snjezana Petrovic, PhD contact
Vesna Vucic, PhD principal investigator
Institute for medical research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milled seed mix in people with Non-hodgkin Lymphoma, run by University of Belgrade at 1 site in Serbia.
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 5 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 20 Mar 2020. 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 Serbia. 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. 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 Zorica Cvetkovic, MD PhD (+381641302624, zokabora@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease status (time frame: Baseline, 5 months, 1 year). 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 NCT03260231, which also lists 3 linked publications.
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 20 Mar 2020.