<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03801837</url>
  </required_header>
  <id_info>
    <org_study_id>5190008</org_study_id>
    <nct_id>NCT03801837</nct_id>
  </id_info>
  <brief_title>Effect of Macadamia Nut on Cardiometabolic Risk Factors</brief_title>
  <acronym>MAC</acronym>
  <official_title>Macadamia Nut Effects on Adiposity and Cardiometabolic Risk Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study will test the effects of macadamia nuts on adiposity, and traditional and&#xD;
      emergent risk factors of cardiometabolic disease in adult men and women&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose of this study is to investigate the effects of Macadamia nuts on body weight,&#xD;
      adiposity, , oxidative stress, glucose, insulin an lipid levels. it will a randomized cross&#xD;
      over study that will include two study diets (Macadamia nut diet and control diet) with a&#xD;
      wash out period of 4 weeks in between. 40 subjects will be selected and randomized into&#xD;
      either of the two phases. During the Macadamia nut diet phase subjects will be provided the&#xD;
      appropriate portion of Macadamia nuts (15% of daily calories or 30-45 grams based on kcal&#xD;
      requirement of the individual, instructions will be provided on how to incorporate nuts into&#xD;
      the diet. this phase will last for 8 weeks. During the control diet phase, subjects will&#xD;
      continue with their normal diet and abstain from eating nuts. subjects will be tested for&#xD;
      various outcomes at baseline and twice at the end of each phase. The intervention will last&#xD;
      for 5 months in total.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 24, 2019</start_date>
  <completion_date type="Actual">November 25, 2019</completion_date>
  <primary_completion_date type="Actual">November 25, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in body weight</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>The objective of this measure is to see if eating macadamia nuts could reduce body weight. An In body machine will be used to identify this by measuring the weight of the participants at the baseline and at the end of each diet phase. The weight will be measured in Kilograms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in body adiposity</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>The objective of this measure is to see if eating Macadamia Nuts could reduce percentage body fat. Air Displacement Plethysmography will be used to determine any change in body percentage fat at the baseline and end of each diet phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in body fat mass</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>The objective of this measure is to see if eating Macadamia nuts could change body fat mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in body percentage fat</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>The objective of this measure is to see if eating Macadamia nuts could change body percentage fat at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in total body water</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>The objective of this measure is to see if eating Macadamia nuts could change total body water at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in skeletal muscle mass</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>The objective of this measure is to see if eating Macadamia nuts could change skeletal muscle mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in lean body mass</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>The objective of this measure is to see if eating Macadamia nuts could change lean body mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in dry lean mass</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>The objective of this measure is to see if eating Macadamia nuts could change dry lean mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in fasting plasma cholesterol (mg/dl)</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in fasting plasma cholesterol (mg/dl) will be measured by an enzymatic method with the use of a single aqueous reagent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in fasting plasma low density lipoprotein cholesterol (mg/dl)</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in fasting plasma low density lipoprotein cholesterol (mg/dl) will be estimated by the use of a two reagent calorimetric enzymatic homogeneous system on the AU480 clinical chemistry analyzer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in fasting plasma high density lipoprotein cholesterol (mg/dl)</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in fasting plasma high density lipoprotein cholesterol (mg/dl) will be measured by a two-phase reaction with calorimetric end point detection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in fasting plasma triglycerides(mg/dl)</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in fasting plasma triglycerides(mg/dl) will be measured by an enzymatic hydrolysis method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in serum apolipoprotein B (mg/dl)</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in serum apolipoprotein B (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in serum apolipoprotein A1 (mg/dl)</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in serum apolipoprotein A1 (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in serum small density low density lipoprotein cholesterol (mg/dl)</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in serum small density low density lipoprotein cholesterol (mg/dl) will be measured using a two reagent calorimetric enzymatic homogenous system on the AU480 clinical chemistry analyzer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in serum oxidized low density lipoprotein (mg/dl)</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in serum oxidized low density lipoprotein (mg/dl) will be measured using a sandwich enzyme-linked immunosorbent assay, Human oxidized low density lipoprotein enzyme linked immunosorbent assay kit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in fasting plasma glucose</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in fasting plasma glucose levels (mg/dl) will be measured on a clinical chemistry analyzer,AU480 Clinical Chemistry Analyzer, (Beckman Coulter, Inc., Diagnostics Division Headquarters, Brea CA 92821.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in fasting plasma insulin</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in fasting plasma insulin (uIU/ml) will be measured measured by solid-phase, two-site chemiluminescent immunometric assays using the IMMULITE 2000, (Siemens Healthcare Diagnostics, Los Angeles, CA 90045)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in insulin resistance</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in insulin resistance will be measured using the Homeostatic Model Assessment calculator version 2 (HOMA2-IR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>effect modification of adiposity</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>The objective of this measure is to determine if adiposity is an effect modifier of low density lipoprotein cholesterol, lowering the effect of the macadamia nut intake. The test of this interaction will be performed using statistical analysis system (SAS) software</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in serum Interleukin -6</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in serum interleukin-6 (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in serum tumor necrosis factor alpha</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in serum tumor necrosis factor alpha (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in serum soluble selectin (ng/ml)</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in serum soluble selectin (ng/ml) will be measured by enzyme linked immunosorbent assay(ELISA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in serum soluble -intercellular adhesion molecule 1 (ng/dl)</measure>
    <time_frame>baselline to 18 weeks</time_frame>
    <description>change in serum soluble -intercellular adhesion molecule 1 (ng/dl)will be measured by enzyme linked immunosorbent assay(ELISA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in serum soluble -vascular adhesion molecule 1 (ng/dl)</measure>
    <time_frame>baselline to 18 weeks</time_frame>
    <description>change in serum soluble -intercellular adhesion molecule 1 (ng/dl)will be measured by enzyme linked immunosorbent assay(ELISA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in C reactive protein</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in C reactive protein (mg/l) will be measured by enzyme linked immunosorbent assay(ELISA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Malondialdehyde</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in Malondialdehyde (micromole/l) will be measured by a competitive enzyme-linked immunosorbent assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Prostaglandin F2 alpha</measure>
    <time_frame>baseline to 18 weeks</time_frame>
    <description>change in Prostaglandin F2 alpha will be measured by a competitive enzyme-linked immunosorbent assay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <condition>Heart Diseases</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Macadamia Nut Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will have their habitual diet supplemented with appropriate portion of Macadamia Nuts (15% of daily calories or 30-45 grams based on Kcal requirement of the individual)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Diet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will continue with their Habitual Diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Macadamia Nut</intervention_name>
    <description>Participants will be provided with the appropriate portion of macadamia nuts [15% of daily calories or 30-45 grams based on kcal requirement of the individual]</description>
    <arm_group_label>Macadamia Nut Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control Diet</intervention_name>
    <description>Participants will continue with their Habitual Diet during this part of the intervention</description>
    <arm_group_label>Control Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and post-menopausal women&#xD;
&#xD;
          -  Overweight (BMI 25-&lt;40)&#xD;
&#xD;
          -  Waist circumference ≥88.9 cm for women and ≥101.6 cm for men&#xD;
&#xD;
          -  At least one of the following within the past year:&#xD;
&#xD;
          -  Plasma triglycerides ≥150mg/dl&#xD;
&#xD;
          -  Blood Pressure ≥130/85 mmHg or participants taking Antihypertensive medication&#xD;
&#xD;
          -  Fasting glucose ≥100 mg/dL&#xD;
&#xD;
          -  Low Density Lipoproteins&gt;= 130 mg/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nut allergy, any&#xD;
&#xD;
          -  Significant chronic disease including: diabetes, congestive heart failure, renal&#xD;
             failure, cirrhosis, or autoimmune disease&#xD;
&#xD;
          -  Medications affecting lipid or glucose metabolism, immune modulators, or antibiotics&#xD;
             in the last 6 months&#xD;
&#xD;
          -  Mega-doses of lipid-lowering dietary supplements in the last 6 months&#xD;
&#xD;
          -  Cancer in the last 10 years (with the exception on non-melanoma skin cancer)&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Weight change of &gt;10% of body weight in the last 3 months.&#xD;
&#xD;
          -  Tobacco use&#xD;
&#xD;
          -  Claustrophobia (may affect BOD POD testing)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joan Sabate, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University School of Public Health</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>March 17, 2023</last_update_submitted>
  <last_update_submitted_qc>March 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loma Linda University</investigator_affiliation>
    <investigator_full_name>Joan Sabate,DrPH, MD</investigator_full_name>
    <investigator_title>Professor of Nutrition</investigator_title>
  </responsible_party>
  <keyword>Macadamia Nuts</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>Inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03801837
org study id: 5190008
nct id: NCT03801837
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study will test the effects of macadamia nuts on adiposity, and traditional and
      emergent risk factors of cardiometabolic disease in adult men and women
Purpose of this study is to investigate the effects of Macadamia nuts on body weight,
      adiposity, , oxidative stress, glucose, insulin an lipid levels. it will a randomized cross
      over study that will include two study diets (Macadamia nut diet and control diet) with a
      wash out period of 4 weeks in between. 40 subjects will be selected and randomized into
      either of the two phases. During the Macadamia nut diet phase subjects will be provided the
      appropriate portion of Macadamia nuts (15% of daily calories or 30-45 grams based on kcal
      requirement of the individual, instructions will be provided on how to incorporate nuts into
      the diet. this phase will last for 8 weeks. During the control diet phase, subjects will
      continue with their normal diet and abstain from eating nuts. subjects will be tested for
      various outcomes at baseline and twice at the end of each phase. The intervention will last
      for 5 months in total.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: change in body weight
time frame: baseline to 18 weeks
description: The objective of this measure is to see if eating macadamia nuts could reduce body weight. An In body machine will be used to identify this by measuring the weight of the participants at the baseline and at the end of each diet phase. The weight will be measured in Kilograms
measure: change in body adiposity
time frame: baseline to 18 weeks
description: The objective of this measure is to see if eating Macadamia Nuts could reduce percentage body fat. Air Displacement Plethysmography will be used to determine any change in body percentage fat at the baseline and end of each diet phase
measure: change in body fat mass
time frame: baseline to 18 weeks
description: The objective of this measure is to see if eating Macadamia nuts could change body fat mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
measure: change in body percentage fat
time frame: baseline to 18 weeks
description: The objective of this measure is to see if eating Macadamia nuts could change body percentage fat at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
measure: change in total body water
time frame: baseline to 18 weeks
description: The objective of this measure is to see if eating Macadamia nuts could change total body water at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
measure: change in skeletal muscle mass
time frame: baseline to 18 weeks
description: The objective of this measure is to see if eating Macadamia nuts could change skeletal muscle mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
measure: change in lean body mass
time frame: baseline to 18 weeks
description: The objective of this measure is to see if eating Macadamia nuts could change lean body mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
measure: change in dry lean mass
time frame: baseline to 18 weeks
description: The objective of this measure is to see if eating Macadamia nuts could change dry lean mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
measure: change in fasting plasma cholesterol (mg/dl)
time frame: baseline to 18 weeks
description: change in fasting plasma cholesterol (mg/dl) will be measured by an enzymatic method with the use of a single aqueous reagent
measure: change in fasting plasma low density lipoprotein cholesterol (mg/dl)
time frame: baseline to 18 weeks
description: change in fasting plasma low density lipoprotein cholesterol (mg/dl) will be estimated by the use of a two reagent calorimetric enzymatic homogeneous system on the AU480 clinical chemistry analyzer
measure: change in fasting plasma high density lipoprotein cholesterol (mg/dl)
time frame: baseline to 18 weeks
description: change in fasting plasma high density lipoprotein cholesterol (mg/dl) will be measured by a two-phase reaction with calorimetric end point detection
measure: change in fasting plasma triglycerides(mg/dl)
time frame: baseline to 18 weeks
description: change in fasting plasma triglycerides(mg/dl) will be measured by an enzymatic hydrolysis method
measure: change in serum apolipoprotein B (mg/dl)
time frame: baseline to 18 weeks
description: change in serum apolipoprotein B (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser
measure: change in serum apolipoprotein A1 (mg/dl)
time frame: baseline to 18 weeks
description: change in serum apolipoprotein A1 (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser
measure: change in serum small density low density lipoprotein cholesterol (mg/dl)
time frame: baseline to 18 weeks
description: change in serum small density low density lipoprotein cholesterol (mg/dl) will be measured using a two reagent calorimetric enzymatic homogenous system on the AU480 clinical chemistry analyzer.
measure: change in serum oxidized low density lipoprotein (mg/dl)
time frame: baseline to 18 weeks
description: change in serum oxidized low density lipoprotein (mg/dl) will be measured using a sandwich enzyme-linked immunosorbent assay, Human oxidized low density lipoprotein enzyme linked immunosorbent assay kit
measure: change in fasting plasma glucose
time frame: baseline to 18 weeks
description: change in fasting plasma glucose levels (mg/dl) will be measured on a clinical chemistry analyzer,AU480 Clinical Chemistry Analyzer, (Beckman Coulter, Inc., Diagnostics Division Headquarters, Brea CA 92821.)
measure: change in fasting plasma insulin
time frame: baseline to 18 weeks
description: change in fasting plasma insulin (uIU/ml) will be measured measured by solid-phase, two-site chemiluminescent immunometric assays using the IMMULITE 2000, (Siemens Healthcare Diagnostics, Los Angeles, CA 90045)
measure: change in insulin resistance
time frame: baseline to 18 weeks
description: change in insulin resistance will be measured using the Homeostatic Model Assessment calculator version 2 (HOMA2-IR)
measure: effect modification of adiposity
time frame: baseline to 18 weeks
description: The objective of this measure is to determine if adiposity is an effect modifier of low density lipoprotein cholesterol, lowering the effect of the macadamia nut intake. The test of this interaction will be performed using statistical analysis system (SAS) software
measure: change in serum Interleukin -6
time frame: baseline to 18 weeks
description: change in serum interleukin-6 (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA)
measure: change in serum tumor necrosis factor alpha
time frame: baseline to 18 weeks
description: change in serum tumor necrosis factor alpha (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA)
measure: change in serum soluble selectin (ng/ml)
time frame: baseline to 18 weeks
description: change in serum soluble selectin (ng/ml) will be measured by enzyme linked immunosorbent assay(ELISA)
measure: change in serum soluble -intercellular adhesion molecule 1 (ng/dl)
time frame: baselline to 18 weeks
description: change in serum soluble -intercellular adhesion molecule 1 (ng/dl)will be measured by enzyme linked immunosorbent assay(ELISA)
measure: change in serum soluble -vascular adhesion molecule 1 (ng/dl)
time frame: baselline to 18 weeks
description: change in serum soluble -intercellular adhesion molecule 1 (ng/dl)will be measured by enzyme linked immunosorbent assay(ELISA)
measure: change in C reactive protein
time frame: baseline to 18 weeks
description: change in C reactive protein (mg/l) will be measured by enzyme linked immunosorbent assay(ELISA)
measure: change in Malondialdehyde
time frame: baseline to 18 weeks
description: change in Malondialdehyde (micromole/l) will be measured by a competitive enzyme-linked immunosorbent assay
measure: change in Prostaglandin F2 alpha
time frame: baseline to 18 weeks
description: change in Prostaglandin F2 alpha will be measured by a competitive enzyme-linked immunosorbent assay
arm group label: Macadamia Nut Diet
arm group type: Active Comparator
description: This group will have their habitual diet supplemented with appropriate portion of Macadamia Nuts (15% of daily calories or 30-45 grams based on Kcal requirement of the individual)
arm group label: Control Diet
arm group type: Placebo Comparator
description: This group will continue with their Habitual Diet
intervention type: Dietary Supplement
intervention name: Macadamia Nut
description: Participants will be provided with the appropriate portion of macadamia nuts [15% of daily calories or 30-45 grams based on kcal requirement of the individual]
arm group label: Macadamia Nut Diet
intervention type: Dietary Supplement
intervention name: Control Diet
description: Participants will continue with their Habitual Diet during this part of the intervention
arm group label: Control Diet
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joan Sabate, DrPH
role: Principal Investigator
affiliation: Loma Linda University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Loma Linda University
investigator full name: Joan Sabate,DrPH, MD
investigator title: Professor of Nutrition
mesh term: Heart Diseases
mesh term: Inflammation
sharing ipd: No