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Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome
NCT05977179 · University of Maryland, Baltimore
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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 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.
Eligibility criteria
Inclusion Criteria:
1. Age of 50 years or older
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:
1. Participants with a home oxygen requirement or requiring chronic ventilator support
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.
Study design
Enrollment target: 56 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-05-12
Estimated completion: 2028-09-30
Last updated: 2025-07-11
Interventions
Other: Dietary intervention to mitigate Post-Acute COVID-19 SyndromeOther: Attention Control
Primary outcomes
- • Fatigue (Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial))
- • Physical Function (Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial))
Sponsor
University of Maryland, Baltimore · other
Contacts & investigators
ContactGalya Bigman, PhD · contact · gbigman@som.umaryland.edu · 5125763823
All locations (1)
University of Maryland, BaltimoreRecruiting
Baltimore, Maryland, United States