Cardiovascular Risk FactorFitALANCT03227497
Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk
A study testing Whole Walnuts in people with Cardiovascular Risk Factor and Metabolic Syndrome, run by University of Belgrade at 1 site in Serbia.
Trial summary
This cross-over study investigates health effects of dietary intake of whole walnuts towards cardiovascular risk factors in adults under low cardiovascular risk. Investigators hypothesize that daily intake of whole nuts as a replacement meal, would improve cardiovascular risk factors, including traditional risk… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Metabolic Syndrome, Hypertension
- What is being tested?
- Whole Walnuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSerbia
- Study dates
- 21 Apr 2017to 15 Jul 2017
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of at least one of the following criteria, formerly assessed through routine medical examination:
- dyslipidemia, defined as the presence of either: elevated total cholesterol (>5.2 mmoL/L), and/or elevated LDL-cholesterol (>3.4 mmoL/L), and/or elevated triglycerides (>1.7 mmoL/L), and/or decreased HDL-cholesterol (<1.6 mmoL/L)
- elevated blood pressure (systolic/diastolic ≥120/80 mmHg), or regular anti-hypertension therapy
Who cannot join
- presence of allergy on any nuts
- presence of any chronic disease, excluding following conditions: hypertension and diabetes mellitus type 2
- smoking
- statin therapy
- pregnancy and/or lactation
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
Belgrade, 11000
About this study
Official title: Investigation of Health Effects of Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk Towards Established and Molecular Cardiovascular Risk Factors
This cross-over study investigates health effects of dietary intake of whole walnuts towards cardiovascular risk factors in adults under low cardiovascular risk.
Investigators hypothesize that daily intake of whole nuts as a replacement meal, would improve cardiovascular risk factors, including traditional risk factors and molecular biomarkers.
The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks.
The study subjects are instructed to continue with their habitual diet and physical activity.
Read the detailed description
Recent literature data raise important questions on the beneficial effect of dietary fats. Dietary intake of nuts, although with high caloric burden, is however characterized with high intake of fatty acids with known beneficial health effects. Those fatty acids include mono- (MUFA) and polyunsaturated fatty acids (PUFA), to whom beneficial health effects are ascribed.
Among nuts, walnuts are characterized with comparatively high levels of MUFA and PUFA, especially content of alpha-linolenic PUFA, considered essential fatty acid, since not synthesized endogenously in humans. Dietary intake of alpha-linolenic acid is shown to be inversely related with cardiovascular risk factors, both in interventional studies and epidemiological cohorts. Molecular background of alpha-linolenic actions is bidirectional, and includes the action itself, as well as beneficial endogenous conversion towards long-chain fatty acids, including eicosapentaenoic and docosahexaenoic fatty acid.
Although high caloric intake is indicated with intake of walnuts, literature data suggest that consumption of walnuts does not increase body weight.
Dietary intake of walnuts has been shown to decrease cholesterol fractions, triglycerides and apolipoproteins in adult population. Also, consumption of walnuts was associated with decrease in blood pressure.
The study design is cross-over, controlled, randomized nutritional intervention. The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks.
The study subjects are instructed to continue with their habitual diet and physical activity. Additionally, study subjects are instructed to avoid walnuts and nuts other then study treatment, during the complete study period of 10 weeks.
Sample size calculation was conducted by use of online calculators, and was based on the low density lipoprotein (LDL) cholesterol. Namely, in order to achieve decrease in 0.5 mmol/L, in a sample with projected standard deviation of 0.7 mmol/L, and type I and II errors being 0.2 and 0.05, respectively, 62 subjects are needed.
- Conditions
- Cardiovascular Risk Factor, Metabolic Syndrome, Hypertension
- Being tested
- Whole Walnuts
- Keywords
- Blood Pressure, Cholesterol, Triglycerides, Walnuts
- Medical subject headings
- Metabolic Syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole WalnutsDietary supplement
Intervention arm includes whole walnuts taken as dietary replacement meal during the day, and between breakfast and lunch, and/or lunch and dinner. Importantly, none of the main meals, including breakfast, lunch and dinner are to be replaced by study intervention, and the study subjects are instructed to do so. Walnuts are provided with the same producer at the Belgrade market.
| Study group | Role | What they receive |
|---|---|---|
| Walnut | Active comparator | At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).
Treatment arm includes 56 g of whole walnuts daily. Receives: Dietary Supplement: Whole Walnuts |
| Control | No intervention | At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in LDL-cholesterol
Changes in LDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Changes in Systolic Blood Pressure
Changes in Systolic Blood Pressure, from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Changes in Diastolic Blood Pressure
Changes in Diastolic Blood Pressure from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Secondary outcomes (17)
Changes in HDL-cholesterol
Changes in HDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Changes in total cholesterol
Changes in total cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Changes in triglycerides
Changes in triglycerides measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Changes in glucose metabolism biomarkers
Changes in glucose biomarkers measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Changes in renal function parameters
Changes in renal function parameters measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Changes in liver function parameters
Changes in liver function parameters measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Changes in body weight
Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Changes in waist circumference
Changes in waist circumference, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Changes in percent of total body fat
Changes in percent of total body fat measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Level of Physical Activity
Level of physical activity is assessed by use of standardized Physical Activity Questionnaire.
Measured: Baseline
Psychological parameters
Psychological parameters are assessed by use of standardized questionnaire for self-assessment of psychological implications of daily activities related to cardiovascular health .
Measured: 5 weeks
Changes in hematological parameters
Changes in hematological, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Changes in number of leukocyte cells
Changes in number of leukocyte cells, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.
Measured: Baseline, 5 weeks, 10 weeks
Changes in total caloric intake
Changes in total caloric intake, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Total caloric intake is measured by use of standardized dietary questionnaire namely 24-hour Dietary Recall.
Measured: Baseline, 5 weeks, 10 weeks
Changes in caloric intake of fats
Changes in caloric intake of fats, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.
Measured: Baseline, 5 weeks, 10 weeks
Changes in caloric intake of carbohydrates
Changes in caloric intake of carbohydrates, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.
Measured: Baseline, 5 weeks, 10 weeks
Changes in caloric intake of vitamin D
Changes in caloric intake of vitamin D, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.
Measured: Baseline, 5 weeks, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start21 Apr 2017
- Primary completion15 Jul 2017
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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
- Crossover
- Model description
- This study is a randomized, cross-over, controlled, 5-week nutritional intervention, investigating health effects of dietary intake of whole walnuts, as a replacement meal within habitual diet and lifestyle. At the beginning of the study, half of the study subjects are randomly assigned to a treatment arm with walnut consumption, or control arm without study intervention. Treatment arm considers consumption of pre-packed 56 g of whole walnuts daily, as a replacement meal. After 5 weeks, study subjects are crossed, for additional 5 weeks. At the beginning of the study, all subjects are instructed to continue with their habitual diet and physical activity during the study period of 10 weeks.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Research Excellence in Nutrition and Metabolism
- Responsible party
- Principal investigator, Manja Zec, University of Belgrade
- Investigators
- Maria Glibetic, Prof, Principal investigator, Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Resaerch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227497
- Sponsor's protocol ID
- EO120/2017
- Acronym
- FitALA
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Health Effects of Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk Towards Established and Molecular Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT03227497
- Acronym / sponsor ID
- FitALA / EO120/2017
- Conditions
- Cardiovascular Risk Factor, Metabolic Syndrome, Hypertension
- Keywords
- Blood Pressure, Cholesterol, Triglycerides, Walnuts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Collaborators
- Centre of Research Excellence in Nutrition and Metabolism
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 24 Jul 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.
This cross-over study investigates health effects of dietary intake of whole walnuts towards cardiovascular risk factors in adults under low cardiovascular risk.
Investigators hypothesize that daily intake of whole nuts as a replacement meal, would improve cardiovascular risk factors, including traditional risk factors and molecular biomarkers.
The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks.
The study subjects are instructed to continue with their habitual diet and physical activity.
Detailed description
Recent literature data raise important questions on the beneficial effect of dietary fats. Dietary intake of nuts, although with high caloric burden, is however characterized with high intake of fatty acids with known beneficial health effects. Those fatty acids include mono- (MUFA) and polyunsaturated fatty acids (PUFA), to whom beneficial health effects are ascribed.
Among nuts, walnuts are characterized with comparatively high levels of MUFA and PUFA, especially content of alpha-linolenic PUFA, considered essential fatty acid, since not synthesized endogenously in humans. Dietary intake of alpha-linolenic acid is shown to be inversely related with cardiovascular risk factors, both in interventional studies and epidemiological cohorts. Molecular background of alpha-linolenic actions is bidirectional, and includes the action itself, as well as beneficial endogenous conversion towards long-chain fatty acids, including eicosapentaenoic and docosahexaenoic fatty acid.
Although high caloric intake is indicated with intake of walnuts, literature data suggest that consumption of walnuts does not increase body weight.
Dietary intake of walnuts has been shown to decrease cholesterol fractions, triglycerides and apolipoproteins in adult population. Also, consumption of walnuts was associated with decrease in blood pressure.
The study design is cross-over, controlled, randomized nutritional intervention. The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks.
The study subjects are instructed to continue with their habitual diet and physical activity. Additionally, study subjects are instructed to avoid walnuts and nuts other then study treatment, during the complete study period of 10 weeks.
Sample size calculation was conducted by use of online calculators, and was based on the low density lipoprotein (LDL) cholesterol. Namely, in order to achieve decrease in 0.5 mmol/L, in a sample with projected standard deviation of 0.7 mmol/L, and type I and II errors being 0.2 and 0.05, respectively, 62 subjects are needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized, cross-over, controlled, 5-week nutritional intervention, investigating health effects of dietary intake of whole walnuts, as a replacement meal within habitual diet and lifestyle. At the beginning of the study, half of the study subjects are randomly assigned to a treatment arm with walnut consumption, or control arm without study intervention. Treatment arm considers consumption of pre-packed 56 g of whole walnuts daily, as a replacement meal. After 5 weeks, study subjects are crossed, for additional 5 weeks. At the beginning of the study, all subjects are instructed to continue with their habitual diet and physical activity during the study period of 10 weeks.
| Arm | Type | Receives |
|---|---|---|
| Walnut | Active comparator | Dietary Supplement: Whole WalnutsAt the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm). Treatment arm includes 56 g of whole walnuts daily. |
| Control | No intervention | –At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of at least one of the following criteria, formerly assessed through routine medical examination:
- dyslipidemia, defined as the presence of either: elevated total cholesterol (>5.2 mmoL/L), and/or elevated LDL-cholesterol (>3.4 mmoL/L), and/or elevated triglycerides (>1.7 mmoL/L), and/or decreased HDL-cholesterol (<1.6 mmoL/L)
- elevated blood pressure (systolic/diastolic ≥120/80 mmHg), or regular anti-hypertension therapy
Key exclusion criteria (5 listed)
- presence of allergy on any nuts
- presence of any chronic disease, excluding following conditions: hypertension and diabetes mellitus type 2
- smoking
- statin therapy
- pregnancy and/or lactation
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 |
|---|---|---|
| Whole WalnutsIntervention arm includes whole walnuts taken as dietary replacement meal during the day, and between breakfast and lunch, and/or lunch and dinner. Importantly, none of the main meals, including breakfast, lunch and dinner are to be replaced by study intervention, and the study subjects are instructed to do so. Walnuts are provided with the same producer at the Belgrade market. | Dietary supplement | Walnut |
Primary outcome
Changes in LDL-cholesterol
Time frame: Baseline, 5 weeks, 10 weeks
Changes in LDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Changes in Systolic Blood Pressure
Time frame: Baseline, 5 weeks, 10 weeks
Changes in Systolic Blood Pressure, from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
Changes in Diastolic Blood Pressure
Time frame: Baseline, 5 weeks, 10 weeks
Changes in Diastolic Blood Pressure from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
17 secondary outcomes
Changes in HDL-cholesterol
Time frame: Baseline, 5 weeks, 10 weeks
Changes in total cholesterol
Time frame: Baseline, 5 weeks, 10 weeks
Changes in triglycerides
Time frame: Baseline, 5 weeks, 10 weeks
Changes in glucose metabolism biomarkers
Time frame: Baseline, 5 weeks, 10 weeks
Changes in renal function parameters
Time frame: Baseline, 5 weeks, 10 weeks
Changes in liver function parameters
Time frame: Baseline, 5 weeks, 10 weeks
Changes in body weight
Time frame: Baseline, 5 weeks, 10 weeks
Changes in waist circumference
Time frame: Baseline, 5 weeks, 10 weeks
Changes in percent of total body fat
Time frame: Baseline, 5 weeks, 10 weeks
Level of Physical Activity
Time frame: Baseline
Psychological parameters
Time frame: 5 weeks
Changes in hematological parameters
Time frame: Baseline, 5 weeks, 10 weeks
Changes in number of leukocyte cells
Time frame: Baseline, 5 weeks, 10 weeks
Changes in total caloric intake
Time frame: Baseline, 5 weeks, 10 weeks
Changes in caloric intake of fats
Time frame: Baseline, 5 weeks, 10 weeks
Changes in caloric intake of carbohydrates
Time frame: Baseline, 5 weeks, 10 weeks
Changes in caloric intake of vitamin D
Time frame: Baseline, 5 weeks, 10 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 24 Jul 2017.
- 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.
Maria Glibetic, Prof principal investigator
Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Resaerch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Walnuts in people with Cardiovascular Risk Factor and Metabolic Syndrome, 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 3 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: finished, as of the sponsor's last update on 24 Jul 2017. 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?
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?
Changes in LDL-cholesterol (time frame: Baseline, 5 weeks, 10 weeks). The study lists 3 primary outcomes in all. 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 24 Jul 2017.