Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome
NCT ID: NCT05977179
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
56 participants
INTERVENTIONAL
2025-05-12
2028-09-30
Brief Summary
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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.
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Detailed Description
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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 will 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Dietary intervention to mitigate Post-Acute COVID-19 Syndrome
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.
Dietary intervention to mitigate Post-Acute COVID-19 Syndrome
As it was described in the arm/group descriptions.
Attention Control
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.
Attention Control
As it was described in the arm/group descriptions.
Interventions
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Dietary intervention to mitigate Post-Acute COVID-19 Syndrome
As it was described in the arm/group descriptions.
Attention Control
As it was described in the arm/group descriptions.
Eligibility Criteria
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Inclusion Criteria
2. No known active infectious disease (COVID-19 or other).
3. Participant diagnosed with long-COVID/ post- acute COVID-19 syndrome (PACS) /ICD-10-CM codes U09.9
4. Moderate/severe fatigue Brief Fatigue Inventory (BFI)≥4
5. Poor diet quality assessed by the short Healthy Eating Index (HEI)\<70
Exclusion Criteria
2. Participants diagnosed with diabetes who do not have a recent HbA1c level or with HbA1c \> 9%
3. Participants diagnosed with Congestive Heart Failure (CHF New York Heart Association) \> class 2
4. Participants with dietary restrictions due to medication use that affects blood clotting, such as Warfarin or other reasons.
5. Evidence of any condition as determined by a physician or the study team that would lead to an increased risk of illness due to any aspect of proposed testing and interventions, or introduce unanticipated confounding of study results.
6. Participants diagnosed with uncontrolled hypertension that will be defined as:
1. Systolic blood pressure consistently equal to or higher than 190 mmHg.
2. Diastolic blood pressure consistently equal to or higher than 110 mmHg.
3. Participants with a recent history of hypertensive crisis (severe elevation in blood pressure requiring immediate medical intervention), regardless of current blood pressure levels.
7. Participants with diet restrictions or allergies that can affect adherence to the diet, such as allergy to fish or shellfish.
8. Participation in another trial in which active intervention is being received.
9. Participants with active drug or alcohol use/dependence that would interfere with adherence to the study.
10. Participants scheduled for surgical procedures within the next 6 months.
11. Participants diagnosed with active cancer.
12. Participants diagnosed with liver diseases.
13. Participants diagnosed with kidney-related conditions, including Chronic Kidney Disease (CKD) \> stage 3.
14. Below the age of 50 years.
50 Years
94 Years
ALL
No
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Galya Bigman
Assistant Professor, University of Maryland, School of Medicine, Baltimore, MD
Locations
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University of Maryland, Baltimore
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Galya Bigman
Role: primary
Other Identifiers
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HP-00106745
Identifier Type: -
Identifier Source: org_study_id
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