Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05977179
Status
Recruiting
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Conditions

  • Fatigue
  • Post-Acute COVID-19 Syndrome

Eligibility Criteria

Sex
ALL
Age
50 Years - 94 Years
Healthy Volunteers
Not accepted

Interventions

  • Dietary intervention to mitigate Post-Acute COVID-19 Syndrome — OTHER
    As it was described in the arm/group descriptions.
  • Attention Control — OTHER
    As it was described in the arm/group descriptions.

Study Details

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.

Key Dates

Start date
May 12, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 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.
  • Other: 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.

Primary Outcome Measure

Fatigue [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland, BaltimoreBaltimoreMaryland21201
Galya Bigman

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