Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 97 of 122 for:    hypertension "vitamin d"

Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk (FitALA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03227497
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Collaborator:
Centre of Research Excellence in Nutrition and Metabolism
Information provided by (Responsible Party):
Manja Zec, University of Belgrade

Brief 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 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Metabolic Syndrome Hypertension Dietary Supplement: Whole Walnuts Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Masking Description: Independent researcher will perform statistical analyses, without prior knowledge on study treatment allocation.
Primary Purpose: Prevention
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
Actual Study Start Date : April 21, 2017
Actual Primary Completion Date : July 15, 2017
Actual Study Completion Date : July 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Walnut

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.

Dietary Supplement: Whole Walnuts
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.

No Intervention: Control
At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Changes in HDL-cholesterol [ Time Frame: Baseline, 5 weeks, 10 weeks ]
    Changes in HDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

  2. Changes in total cholesterol [ Time Frame: Baseline, 5 weeks, 10 weeks ]
    Changes in total cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

  3. Changes in triglycerides [ Time Frame: Baseline, 5 weeks, 10 weeks ]
    Changes in triglycerides measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

  4. Changes in glucose metabolism biomarkers [ Time Frame: Baseline, 5 weeks, 10 weeks ]
    Changes in glucose biomarkers measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

  5. Changes in renal function parameters [ Time Frame: Baseline, 5 weeks, 10 weeks ]
    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.

  6. Changes in liver function parameters [ Time Frame: Baseline, 5 weeks, 10 weeks ]
    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.

  7. Changes in body weight [ Time Frame: Baseline, 5 weeks, 10 weeks ]
    Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

  8. Changes in waist circumference [ Time Frame: Baseline, 5 weeks, 10 weeks ]
    Changes in waist circumference, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

  9. Changes in percent of total body fat [ Time Frame: Baseline, 5 weeks, 10 weeks ]
    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.

  10. Level of Physical Activity [ Time Frame: Baseline ]
    Level of physical activity is assessed by use of standardized Physical Activity Questionnaire.

  11. Psychological parameters [ Time Frame: 5 weeks ]
    Psychological parameters are assessed by use of standardized questionnaire for self-assessment of psychological implications of daily activities related to cardiovascular health .

  12. Changes in hematological parameters [ Time Frame: Baseline, 5 weeks, 10 weeks ]
    Changes in hematological, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.

  13. Changes in number of leukocyte cells [ Time Frame: Baseline, 5 weeks, 10 weeks ]
    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.

  14. Changes in total caloric intake [ Time Frame: Baseline, 5 weeks, 10 weeks ]

    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.


  15. Changes in caloric intake of fats [ Time Frame: Baseline, 5 weeks, 10 weeks ]

    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.


  16. Changes in caloric intake of carbohydrates [ Time Frame: Baseline, 5 weeks, 10 weeks ]

    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.


  17. Changes in caloric intake of vitamin D [ Time Frame: Baseline, 5 weeks, 10 weeks ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227497


Locations
Layout table for location information
Serbia
Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
Belgrade, Serbia, 11000
Sponsors and Collaborators
University of Belgrade
Centre of Research Excellence in Nutrition and Metabolism
Investigators
Layout table for investigator information
Principal Investigator: Maria Glibetic, Prof Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Resaerch

Layout table for additonal information
Responsible Party: Manja Zec, Dr, University of Belgrade
ClinicalTrials.gov Identifier: NCT03227497     History of Changes
Other Study ID Numbers: EO120/2017
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manja Zec, University of Belgrade:
Blood Pressure
Cholesterol
Triglycerides
Walnuts

Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases