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/NCT05977179</url>
    </required_header>
    <id_info>
      <org_study_id>HP-00106745</org_study_id>
      <nct_id>NCT05977179</nct_id>
    </id_info>
    <brief_title>Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome</brief_title>
    <official_title>A Diet Intervention Study To Mitigate Fatigue Symptoms And To Improve Muscle And Physical Function In Older Adults With Post-Acute COVID-19 Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Maryland, Baltimore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Maryland, Baltimore</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective of this study is to conduct a 16-week randomized controlled trial aimed&#xD;
        at investigating the effectiveness of the Whole-Diet Approach when following a healthy&#xD;
        US-style diet rich in anti-inflammatory properties. The study will focus on evaluating its&#xD;
        impact on reducing symptoms related to Post-Acute Sequelae of SARS-CoV-2 Infection (PACS) in&#xD;
        adults aged 50 years and older.&#xD;
  &#xD;
        The main research questions this study aims to answer are:&#xD;
  &#xD;
          1. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory&#xD;
             properties, effectively mitigate fatigue symptoms in adults with PACS?&#xD;
  &#xD;
          2. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory&#xD;
             properties, effectively mitigate declines in muscle function and physical performance in&#xD;
             adults with PACS?&#xD;
  &#xD;
        At the beginning of the study, eligible participants will be randomly assigned to either the&#xD;
        Dietary Intervention Group, where they will receive personalized dietary plans and weekly&#xD;
        sessions, or the Attention Control Group, where they will attend general health sessions on a&#xD;
        weekly basis as well.&#xD;
  &#xD;
        This research intends to shed light on the potential benefits of the Whole-Diet Approach and&#xD;
        its role in ameliorating PACS-related symptoms among older adults. By comparing the outcomes&#xD;
        of the two groups, we hope to gain valuable insights into the effectiveness of this dietary&#xD;
        intervention in improving the quality of life for individuals dealing with PACS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main objective of this research is to evaluate the impact of the 'Whole-Diet Approach'&#xD;
        through a 16-week randomized-controlled dietary intervention on reducing symptoms of PACS&#xD;
        (Post-Acute Sequelae of SARS-CoV-2 Infection), specifically targeting fatigue and muscle&#xD;
        weakness.&#xD;
  &#xD;
        The study will include 56 men and women aged 50 years or older, all diagnosed with PACS.&#xD;
        These participants will be randomly assigned to one of the two groups:&#xD;
  &#xD;
          1. Dietary Intervention Group: Participants in this group will benefit from a personalized&#xD;
             dietary plan created by a skilled Registered Dietitian (RD). The dietary recommendations&#xD;
             will align with the U.S. Healthy diet style as outlined by the Dietary Guidelines for&#xD;
             Americans 2020-2025. Weekly group sessions with the RD/Principal Investigator (PI) will&#xD;
             facilitate the practical application of the personalized diet. The RD will also focus on&#xD;
             promoting the intake of foods with high anti-inflammatory activities.&#xD;
  &#xD;
          2. Attention Control Group: Participants in this group will attend educational sessions on&#xD;
             general health topics, such as healthy aging (e.g., oral health, hearing loss, eyesight)&#xD;
             and safety environment (e.g., gas leaks, fire, fall hazards). However, they will not&#xD;
             receive any specific dietary information.&#xD;
  &#xD;
        Throughout the 16-week intervention period, all participants will be required to strictly&#xD;
        adhere to their prescribed dietary plan and attend the designated sessions.&#xD;
  &#xD;
        The study's primary objectives are as follows:&#xD;
  &#xD;
        Aim 1: Evaluate the effect of the Whole-Diet Approach on the participants' Healthy Eating&#xD;
        Index and fatigue levels, in comparison to the attention control group, among adults with&#xD;
        PACS.&#xD;
  &#xD;
        Aim 2: Assess the impact of the dietary intervention on muscle mass, strength, and physical&#xD;
        function in adults with PACS, and compare these outcomes with the attention control group.&#xD;
  &#xD;
        By addressing these key aims, this research aims to provide valuable insights into the&#xD;
        effectiveness of the Whole-Diet Approach as a potential intervention for alleviating symptoms&#xD;
        related to PACS and enhancing overall well-being among older adults.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2026</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>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fatigue</measure>
      <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)</time_frame>
      <description>Fatigue will be assessed by the brief fatigue inventory (BFI)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical Function</measure>
      <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)</time_frame>
      <description>Physical Function will be measured by the Short Physical Performance Battery(SPPB)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Post-Acute COVID-19 Syndrome</condition>
    <condition>Fatigue</condition>
    <arm_group>
      <arm_group_label>Dietary intervention to mitigate Post-Acute COVID-19 Syndrome</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During the intervention, participants will receive an individual dietary plan from a Registered Dietitian (RD) that emphasizes nutrients with high anti-inflammatory activity, which can be obtained from various foods and supplements (e.g., vitamin D, omega-3, and quality protein). Additionally, participants will actively participate in weekly dietary sessions that cover topics from 'What's On Your Plate?', specifically tailored to address the nutrition recommendations for older adults in the Dietary Guidelines for Americans 2020-2025.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Attention Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants in the control group will receive an equal amount of social attention, in terms of both dose and duration, comparable to that provided in the intervention group. Topics covered during these sessions will focus on healthy aging, including oral health, hearing loss, eyesight, and ensuring a safe environment by addressing issues such as gas leaks, fire hazards, and fall prevention. No dietary information will be included in these discussions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dietary intervention to mitigate Post-Acute COVID-19 Syndrome</intervention_name>
      <description>As it was described in the arm/group descriptions.</description>
      <arm_group_label>Dietary intervention to mitigate Post-Acute COVID-19 Syndrome</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Attention Control</intervention_name>
      <description>As it was described in the arm/group descriptions.</description>
      <arm_group_label>Attention Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age of 50 years or older&#xD;
  &#xD;
            2. No known active infectious disease (COVID-19 or other).&#xD;
  &#xD;
            3. Participant diagnosed with long-COVID/ post- acute COVID-19 syndrome (PACS) /ICD-10-CM&#xD;
               codes U09.9&#xD;
  &#xD;
            4. Moderate/severe fatigue Brief Fatigue Inventory (BFI)≥4&#xD;
  &#xD;
            5. Poor diet quality assessed by the short Healthy Eating Index (HEI)&lt;70&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participants with a home oxygen requirement or requiring chronic ventilator support&#xD;
  &#xD;
            2. Participants diagnosed with diabetes who do not have a recent HbA1c level or with&#xD;
               HbA1c &gt; 9%&#xD;
  &#xD;
            3. Participants diagnosed with Congestive Heart Failure (CHF New York Heart Association)&#xD;
               &gt; class 2&#xD;
  &#xD;
            4. Participants with dietary restrictions due to medication use that affects blood&#xD;
               clotting, such as Warfarin or other reasons.&#xD;
  &#xD;
            5. Evidence of any condition as determined by a physician or the study team that would&#xD;
               lead to an increased risk of illness due to any aspect of proposed testing and&#xD;
               interventions, or introduce unanticipated confounding of study results.&#xD;
  &#xD;
            6. Participants diagnosed with uncontrolled hypertension that will be defined as:&#xD;
  &#xD;
                 1. Systolic blood pressure consistently equal to or higher than 190 mmHg.&#xD;
  &#xD;
                 2. Diastolic blood pressure consistently equal to or higher than 110 mmHg.&#xD;
  &#xD;
                 3. Participants with a recent history of hypertensive crisis (severe elevation in&#xD;
                    blood pressure requiring immediate medical intervention), regardless of current&#xD;
                    blood pressure levels.&#xD;
  &#xD;
            7. Participants with diet restrictions or allergies that can affect adherence to the&#xD;
               diet, such as allergy to fish or shellfish.&#xD;
  &#xD;
            8. Participation in another trial in which active intervention is being received.&#xD;
  &#xD;
            9. Participants with active drug or alcohol use/dependence that would interfere with&#xD;
               adherence to the study.&#xD;
  &#xD;
           10. Participants scheduled for surgical procedures within the next 6 months.&#xD;
  &#xD;
           11. Participants diagnosed with active cancer.&#xD;
  &#xD;
           12. Participants diagnosed with liver diseases.&#xD;
  &#xD;
           13. Participants diagnosed with kidney-related conditions, including Chronic Kidney&#xD;
               Disease (CKD) &gt; stage 3.&#xD;
  &#xD;
           14. Below the age of 50 years.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>94 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Galya Bigman, PhD</last_name>
      <phone>5125763823</phone>
      <email>bigman.galya@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alice Ryan, PhD</last_name>
      <email>aryan@som.umaryland.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
      <investigator_full_name>Alice Ryan</investigator_full_name>
      <investigator_title>Professor, Tenure, University of Maryland, School of Medicine, Baltimore, MD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Post-Acute COVID-19 Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Fatigue</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05977179
  org study id: HP-00106745
  nct id: NCT05977179
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of this study is to conduct a 16-week randomized controlled trial aimed
        at investigating the effectiveness of the Whole-Diet Approach when following a healthy
        US-style diet rich in anti-inflammatory properties. The study will focus on evaluating its
        impact on reducing symptoms related to Post-Acute Sequelae of SARS-CoV-2 Infection (PACS) in
        adults aged 50 years and older.
  
        The main research questions this study aims to answer are:
  
          1. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory
             properties, effectively mitigate fatigue symptoms in adults with PACS?
  
          2. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory
             properties, effectively mitigate declines in muscle function and physical performance in
             adults with PACS?
  
        At the beginning of the study, eligible participants will be randomly assigned to either the
        Dietary Intervention Group, where they will receive personalized dietary plans and weekly
        sessions, or the Attention Control Group, where they will attend general health sessions on a
        weekly basis as well.
  
        This research intends to shed light on the potential benefits of the Whole-Diet Approach and
        its role in ameliorating PACS-related symptoms among older adults. By comparing the outcomes
        of the two groups, we hope to gain valuable insights into the effectiveness of this dietary
        intervention in improving the quality of life for individuals dealing with PACS.
  The main objective of this research is to evaluate the impact of the 'Whole-Diet Approach'
        through a 16-week randomized-controlled dietary intervention on reducing symptoms of PACS
        (Post-Acute Sequelae of SARS-CoV-2 Infection), specifically targeting fatigue and muscle
        weakness.
  
        The study will include 56 men and women aged 50 years or older, all diagnosed with PACS.
        These participants will be randomly assigned to one of the two groups:
  
          1. Dietary Intervention Group: Participants in this group will benefit from a personalized
             dietary plan created by a skilled Registered Dietitian (RD). The dietary recommendations
             will align with the U.S. Healthy diet style as outlined by the Dietary Guidelines for
             Americans 2020-2025. Weekly group sessions with the RD/Principal Investigator (PI) will
             facilitate the practical application of the personalized diet. The RD will also focus on
             promoting the intake of foods with high anti-inflammatory activities.
  
          2. Attention Control Group: Participants in this group will attend educational sessions on
             general health topics, such as healthy aging (e.g., oral health, hearing loss, eyesight)
             and safety environment (e.g., gas leaks, fire, fall hazards). However, they will not
             receive any specific dietary information.
  
        Throughout the 16-week intervention period, all participants will be required to strictly
        adhere to their prescribed dietary plan and attend the designated sessions.
  
        The study's primary objectives are as follows:
  
        Aim 1: Evaluate the effect of the Whole-Diet Approach on the participants' Healthy Eating
        Index and fatigue levels, in comparison to the attention control group, among adults with
        PACS.
  
        Aim 2: Assess the impact of the dietary intervention on muscle mass, strength, and physical
        function in adults with PACS, and compare these outcomes with the attention control group.
  
        By addressing these key aims, this research aims to provide valuable insights into the
        effectiveness of the Whole-Diet Approach as a potential intervention for alleviating symptoms
        related to PACS and enhancing overall well-being among older adults.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Fatigue
  time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)
  description: Fatigue will be assessed by the brief fatigue inventory (BFI)
  measure: Physical Function
  time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)
  description: Physical Function will be measured by the Short Physical Performance Battery(SPPB)
  arm group label: Dietary intervention to mitigate Post-Acute COVID-19 Syndrome
  arm group type: Experimental
  description: During the intervention, participants will receive an individual dietary plan from a Registered Dietitian (RD) that emphasizes nutrients with high anti-inflammatory activity, which can be obtained from various foods and supplements (e.g., vitamin D, omega-3, and quality protein). Additionally, participants will actively participate in weekly dietary sessions that cover topics from 'What's On Your Plate?', specifically tailored to address the nutrition recommendations for older adults in the Dietary Guidelines for Americans 2020-2025.
  arm group label: Attention Control
  arm group type: Other
  description: Participants in the control group will receive an equal amount of social attention, in terms of both dose and duration, comparable to that provided in the intervention group. Topics covered during these sessions will focus on healthy aging, including oral health, hearing loss, eyesight, and ensuring a safe environment by addressing issues such as gas leaks, fire hazards, and fall prevention. No dietary information will be included in these discussions.
  intervention type: Other
  intervention name: Dietary intervention to mitigate Post-Acute COVID-19 Syndrome
  description: As it was described in the arm/group descriptions.
  arm group label: Dietary intervention to mitigate Post-Acute COVID-19 Syndrome
  intervention type: Other
  intervention name: Attention Control
  description: As it was described in the arm/group descriptions.
  arm group label: Attention Control
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 94 Years
  healthy volunteers: No
  last name: Galya Bigman, PhD
  phone: 5125763823
  email: bigman.galya@gmail.com
  last name: Alice Ryan, PhD
  email: aryan@som.umaryland.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Maryland, Baltimore
  investigator full name: Alice Ryan
  investigator title: Professor, Tenure, University of Maryland, School of Medicine, Baltimore, MD
  mesh term: COVID-19
  mesh term: Post-Acute COVID-19 Syndrome
  mesh term: Syndrome
  mesh term: Fatigue
  sharing ipd: No