xml: <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/NCT06029647</url>
    </required_header>
    <id_info>
      <org_study_id>603036</org_study_id>
      <nct_id>NCT06029647</nct_id>
    </id_info>
    <brief_title>Mangos to Reduce Cardiometabolic Risk Markers</brief_title>
    <official_title>Mangos to Reduce Cardiometabolic Risk Markers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>California State Polytechnic University, Pomona</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>California State Polytechnic University, Pomona</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 determine the effects of mango consumption on blood pressure, body&#xD;
        weight, dietary nutrient/pattern changes, total cholesterol, LDL-cholesterol,&#xD;
        VLDL-cholesterol, triglycerides, and HDL-cholesterol in individuals with moderately elevated&#xD;
        blood pressure and/or LDL-cholesterol.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiovascular disease (CVD) is the leading cause of death in the United States and&#xD;
        worldwide. Risk factors for CVD include, obesity, high serum concentrations of low-density&#xD;
        lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol,&#xD;
        triglycerides, and total cholesterol, as well as low serum concentrations of high-density&#xD;
        lipoprotein (HDL) cholesterol. Hypertension (high blood pressure) is an additional risk&#xD;
        factor for CVD. Dietary strategies to reduce the risk for CVD include consuming adequate&#xD;
        amounts of fruits, vegetables, and whole grains. However, there is limited published research&#xD;
        regarding the effects of specific food items on CVD risk factors. One such example are&#xD;
        mangos; there are murine studies, but there is a paucity of human clinical trial research on&#xD;
        the effects of mango consumption on decreasing the risk factors for CVD. Therefore, the&#xD;
        objective of this proposed study will examine whether mango consumption lowers these CVD risk&#xD;
        factors in individuals with hypertension and/or dyslipidemia. The hypothesis is that mango&#xD;
        consumption will decrease LDL-cholesterol, VLDL-cholesterol, triglycerides, total&#xD;
        cholesterol, body weight, and blood pressure, and increase HDL-cholesterol. This proposed&#xD;
        study will follow a randomized, controlled, cross-over design. Blood draws will be performed&#xD;
        at baseline, after 8 weeks, and at the end of each dietary treatment, at the Student Health&#xD;
        Services at California State Polytechnic University, Pomona. In addition, height, body&#xD;
        weight, and blood pressure measurements will be taken. Subsequently, lipid panels will be&#xD;
        generated for each participant, and those with dyslipidemia and/or hypertension will consume&#xD;
        either 1 cup of mango or vanilla wafers (iso-caloric control) per day for 16 weeks. After a&#xD;
        4-week washout period, the subjects will consume the other dietary treatment for 16 weeks.&#xD;
        Two-way repeated measures Analysis of Variance (ANOVA), followed by least significant&#xD;
        difference (LSD) post-hoc analysis, will be used to determine if there are significant&#xD;
        differences in CVD risk factors between the mango and wafer diets. Furthermore, the&#xD;
        participants will complete two 24-hour recalls during the week before each laboratory visit.&#xD;
        It is expected that the consumption of mangos will decrease LDL-cholesterol,&#xD;
        VLDL-cholesterol, triglycerides, total cholesterol, body weight, and blood pressure, and&#xD;
        increase HDL-cholesterol compared to the wafer diet. This proposed study will be the first to&#xD;
        determine the cardiovascular health benefits of mango consumption in humans.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>
      <intervention_model_description>The study will follow a randomized, controlled, crossover design with two 16-week dietary interventions separated by 4-week washout periods.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Blood pressure (mm Hg)</measure>
      <time_frame>16 weeks for mango consumption and 16 weeks for vanilla wafer consumption</time_frame>
      <description>Systolic and diastolic blood pressure will be measured.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Body weight (kg) and height (cm)</measure>
      <time_frame>16 weeks for mango consumption and 16 weeks for vanilla wafer consumption</time_frame>
      <description>Body weight, height, and body mass index (BMI) will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood lipids (mg/dL)</measure>
      <time_frame>16 weeks for mango consumption and 16 weeks for vanilla wafer consumption</time_frame>
      <description>Total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary analysis (six 24-hour dietary recalls per person in each treatment arm)</measure>
      <time_frame>16 weeks for mango consumption and 16 weeks for vanilla wafer consumption</time_frame>
      <description>Dietary nutrient consumption will be measured (g or mg).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Mango</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants will consume one cup of fresh mango (100 kcal) per day for sixteen weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wafer</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The participants will consume vanilla wafers (100 kcal) per day for sixteen weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mango</intervention_name>
      <description>The participants will consume the treatment for 16 weeks, followed by a 4-week washout period.</description>
      <arm_group_label>Mango</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>vanilla wafers</intervention_name>
      <description>vanilla wafers</description>
      <arm_group_label>Wafer</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Apparently healthy students (18 to 40 years)&#xD;
  &#xD;
            -  Attend California State Polytechnic University, Pomona&#xD;
  &#xD;
            -  Moderately elevated blood pressure (systolic greater than 120 mm Hg or diastolic&#xD;
               greater than 80 mm Hg) and/or LDL-cholesterol (greater than 100 mg/dL)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smokers&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Any medical issues&#xD;
  &#xD;
            -  Allergies or dislike of mangos&#xD;
  &#xD;
            -  Allergies to wheat, milk, eggs, and/or soy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Erik Froyen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cal Poly Pomona</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Bonny Burns-Whitmore, DrPH, RD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cal Poly Pomona</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Craig LaMunyon, PhD</last_name>
      <phone>909-869-2273</phone>
      <email>cwlamunyon@cpp.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anastasia Rutherford, MA</last_name>
      <phone>909-869-2954</phone>
      <email>arutherford@cpp.edu</email>
    </overall_contact_backup>
    <reference>
      <citation>GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 May 11;393(10184):1958-1972. doi: 10.1016/S0140-6736(19)30041-8. Epub 2019 Apr 4. Erratum In: Lancet. 2021 Jun 26;397(10293):2466.</citation>
      <PMID>30954305</PMID>
    </reference>
    <reference>
      <citation>Lee-Kwan SH, Moore LV, Blanck HM, Harris DM, Galuska D. Disparities in State-Specific Adult Fruit and Vegetable Consumption - United States, 2015. MMWR Morb Mortal Wkly Rep. 2017 Nov 17;66(45):1241-1247. doi: 10.15585/mmwr.mm6645a1.</citation>
      <PMID>29145355</PMID>
    </reference>
    <reference>
      <citation>Gorinstein S, Zemser M, Haruenkit R, Chuthakorn R, Grauer F, Martin-Belloso O, Trakhtenberg S. Comparative content of total polyphenols and dietary fiber in tropical fruits and persimmon. J Nutr Biochem. 1999 Jun;10(6):367-71. doi: 10.1016/s0955-2863(99)00017-0.</citation>
      <PMID>15539312</PMID>
    </reference>
    <reference>
      <citation>Papanikolaou Y, Fulgoni VL 3rd. Mango Consumption Is Associated with Improved Nutrient Intakes, Diet Quality, and Weight-Related Health Outcomes. Nutrients. 2021 Dec 24;14(1):59. doi: 10.3390/nu14010059.</citation>
      <PMID>35010933</PMID>
    </reference>
    <reference>
      <citation>Arshad F, Umbreen H, Aslam I, Hameed A, Aftab K, Al-Qahtani WH, Aslam N, Noreen R. Therapeutic Role of Mango Peels in Management of Dyslipidemia and Oxidative Stress in Obese Females. Biomed Res Int. 2021 Oct 23;2021:3094571. doi: 10.1155/2021/3094571. eCollection 2021.</citation>
      <PMID>34725636</PMID>
    </reference>
    <reference>
      <citation>Evans SF, Beebe M, Mahmood M, Janthachotikun S, Eldoumi H, Peterson S, Payton M, Perkins-Veazie P, Smith BJ, Lucas EA. Mango Supplementation Has No Effects on Inflammatory Mediators in Obese Adults. Nutr Metab Insights. 2017 Sep 25;10:1178638817731770. doi: 10.1177/1178638817731770. eCollection 2017.</citation>
      <PMID>28983188</PMID>
    </reference>
    <reference>
      <citation>O'Hara C, Ojo B, Emerson SR, Simenson AJ, Peterson S, Perkins-Veazie P, Payton ME, Hermann J, Smith BJ, Lucas EA. Acute Freeze-Dried Mango Consumption With a High-Fat Meal has Minimal Effects on Postprandial Metabolism, Inflammation and Antioxidant Enzymes. Nutr Metab Insights. 2019 Aug 19;12:1178638819869946. doi: 10.1177/1178638819869946. eCollection 2019.</citation>
      <PMID>31452602</PMID>
    </reference>
    <reference>
      <citation>Rosas M Jr, Pinneo S, O'Mealy C, Tsang M, Liu C, Kern M, Hooshmand S, Hong MY. Effects of fresh mango consumption on cardiometabolic risk factors in overweight and obese adults. Nutr Metab Cardiovasc Dis. 2022 Feb;32(2):494-503. doi: 10.1016/j.numecd.2021.11.001. Epub 2021 Nov 12.</citation>
      <PMID>34953634</PMID>
    </reference>
    <reference>
      <citation>Ross SM. African mango (IGOB131): a proprietary seed extract of Irvingia gabonensis is found to be effective in reducing body weight and improving metabolic parameters in overweight humans. Holist Nurs Pract. 2011 Jul-Aug;25(4):215-7. doi: 10.1097/HNP.0b013e318222735a. No abstract available.</citation>
      <PMID>21697664</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>California State Polytechnic University, Pomona</investigator_affiliation>
      <investigator_full_name>Erik Froyen, PhD</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>We do not plan to share the data with other researchers.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029647
  org study id: 603036
  nct id: NCT06029647
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research study will determine the effects of mango consumption on blood pressure, body
        weight, dietary nutrient/pattern changes, total cholesterol, LDL-cholesterol,
        VLDL-cholesterol, triglycerides, and HDL-cholesterol in individuals with moderately elevated
        blood pressure and/or LDL-cholesterol.
  Cardiovascular disease (CVD) is the leading cause of death in the United States and
        worldwide. Risk factors for CVD include, obesity, high serum concentrations of low-density
        lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol,
        triglycerides, and total cholesterol, as well as low serum concentrations of high-density
        lipoprotein (HDL) cholesterol. Hypertension (high blood pressure) is an additional risk
        factor for CVD. Dietary strategies to reduce the risk for CVD include consuming adequate
        amounts of fruits, vegetables, and whole grains. However, there is limited published research
        regarding the effects of specific food items on CVD risk factors. One such example are
        mangos; there are murine studies, but there is a paucity of human clinical trial research on
        the effects of mango consumption on decreasing the risk factors for CVD. Therefore, the
        objective of this proposed study will examine whether mango consumption lowers these CVD risk
        factors in individuals with hypertension and/or dyslipidemia. The hypothesis is that mango
        consumption will decrease LDL-cholesterol, VLDL-cholesterol, triglycerides, total
        cholesterol, body weight, and blood pressure, and increase HDL-cholesterol. This proposed
        study will follow a randomized, controlled, cross-over design. Blood draws will be performed
        at baseline, after 8 weeks, and at the end of each dietary treatment, at the Student Health
        Services at California State Polytechnic University, Pomona. In addition, height, body
        weight, and blood pressure measurements will be taken. Subsequently, lipid panels will be
        generated for each participant, and those with dyslipidemia and/or hypertension will consume
        either 1 cup of mango or vanilla wafers (iso-caloric control) per day for 16 weeks. After a
        4-week washout period, the subjects will consume the other dietary treatment for 16 weeks.
        Two-way repeated measures Analysis of Variance (ANOVA), followed by least significant
        difference (LSD) post-hoc analysis, will be used to determine if there are significant
        differences in CVD risk factors between the mango and wafer diets. Furthermore, the
        participants will complete two 24-hour recalls during the week before each laboratory visit.
        It is expected that the consumption of mangos will decrease LDL-cholesterol,
        VLDL-cholesterol, triglycerides, total cholesterol, body weight, and blood pressure, and
        increase HDL-cholesterol compared to the wafer diet. This proposed study will be the first to
        determine the cardiovascular health benefits of mango consumption in humans.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: The study will follow a randomized, controlled, crossover design with two 16-week dietary interventions separated by 4-week washout periods.
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Blood pressure (mm Hg)
  time frame: 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
  description: Systolic and diastolic blood pressure will be measured.
  measure: Body weight (kg) and height (cm)
  time frame: 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
  description: Body weight, height, and body mass index (BMI) will be measured.
  measure: Blood lipids (mg/dL)
  time frame: 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
  description: Total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides will be measured.
  measure: Dietary analysis (six 24-hour dietary recalls per person in each treatment arm)
  time frame: 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
  description: Dietary nutrient consumption will be measured (g or mg).
  arm group label: Mango
  arm group type: Experimental
  description: The participants will consume one cup of fresh mango (100 kcal) per day for sixteen weeks.
  arm group label: Wafer
  arm group type: Placebo Comparator
  description: The participants will consume vanilla wafers (100 kcal) per day for sixteen weeks.
  intervention type: Other
  intervention name: Mango
  description: The participants will consume the treatment for 16 weeks, followed by a 4-week washout period.
  arm group label: Mango
  intervention type: Other
  intervention name: vanilla wafers
  description: vanilla wafers
  arm group label: Wafer
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Erik Froyen, PhD
  role: Principal Investigator
  affiliation: Cal Poly Pomona
  last name: Bonny Burns-Whitmore, DrPH, RD
  role: Principal Investigator
  affiliation: Cal Poly Pomona
  last name: Craig LaMunyon, PhD
  phone: 909-869-2273
  email: cwlamunyon@cpp.edu
  last name: Anastasia Rutherford, MA
  phone: 909-869-2954
  email: arutherford@cpp.edu
  citation: GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 May 11;393(10184):1958-1972. doi: 10.1016/S0140-6736(19)30041-8. Epub 2019 Apr 4. Erratum In: Lancet. 2021 Jun 26;397(10293):2466.
  PMID: 30954305
  citation: Lee-Kwan SH, Moore LV, Blanck HM, Harris DM, Galuska D. Disparities in State-Specific Adult Fruit and Vegetable Consumption - United States, 2015. MMWR Morb Mortal Wkly Rep. 2017 Nov 17;66(45):1241-1247. doi: 10.15585/mmwr.mm6645a1.
  PMID: 29145355
  citation: Gorinstein S, Zemser M, Haruenkit R, Chuthakorn R, Grauer F, Martin-Belloso O, Trakhtenberg S. Comparative content of total polyphenols and dietary fiber in tropical fruits and persimmon. J Nutr Biochem. 1999 Jun;10(6):367-71. doi: 10.1016/s0955-2863(99)00017-0.
  PMID: 15539312
  citation: Papanikolaou Y, Fulgoni VL 3rd. Mango Consumption Is Associated with Improved Nutrient Intakes, Diet Quality, and Weight-Related Health Outcomes. Nutrients. 2021 Dec 24;14(1):59. doi: 10.3390/nu14010059.
  PMID: 35010933
  citation: Arshad F, Umbreen H, Aslam I, Hameed A, Aftab K, Al-Qahtani WH, Aslam N, Noreen R. Therapeutic Role of Mango Peels in Management of Dyslipidemia and Oxidative Stress in Obese Females. Biomed Res Int. 2021 Oct 23;2021:3094571. doi: 10.1155/2021/3094571. eCollection 2021.
  PMID: 34725636
  citation: Evans SF, Beebe M, Mahmood M, Janthachotikun S, Eldoumi H, Peterson S, Payton M, Perkins-Veazie P, Smith BJ, Lucas EA. Mango Supplementation Has No Effects on Inflammatory Mediators in Obese Adults. Nutr Metab Insights. 2017 Sep 25;10:1178638817731770. doi: 10.1177/1178638817731770. eCollection 2017.
  PMID: 28983188
  citation: O'Hara C, Ojo B, Emerson SR, Simenson AJ, Peterson S, Perkins-Veazie P, Payton ME, Hermann J, Smith BJ, Lucas EA. Acute Freeze-Dried Mango Consumption With a High-Fat Meal has Minimal Effects on Postprandial Metabolism, Inflammation and Antioxidant Enzymes. Nutr Metab Insights. 2019 Aug 19;12:1178638819869946. doi: 10.1177/1178638819869946. eCollection 2019.
  PMID: 31452602
  citation: Rosas M Jr, Pinneo S, O'Mealy C, Tsang M, Liu C, Kern M, Hooshmand S, Hong MY. Effects of fresh mango consumption on cardiometabolic risk factors in overweight and obese adults. Nutr Metab Cardiovasc Dis. 2022 Feb;32(2):494-503. doi: 10.1016/j.numecd.2021.11.001. Epub 2021 Nov 12.
  PMID: 34953634
  citation: Ross SM. African mango (IGOB131): a proprietary seed extract of Irvingia gabonensis is found to be effective in reducing body weight and improving metabolic parameters in overweight humans. Holist Nurs Pract. 2011 Jul-Aug;25(4):215-7. doi: 10.1097/HNP.0b013e318222735a. No abstract available.
  PMID: 21697664
  responsible party type: Principal Investigator
  investigator affiliation: California State Polytechnic University, Pomona
  investigator full name: Erik Froyen, PhD
  investigator title: Assistant Professor
  sharing ipd: No
  ipd description: We do not plan to share the data with other researchers.