Post-Acute COVID-19 SyndromeLong-COVIDietNCT05977179
Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome
A study testing Dietary intervention to mitigate Post-Acute COVID-19 Syndrome in people with Post-Acute COVID-19 Syndrome and Fatigue, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 94 years
- Conditions the study is for
- Post-Acute COVID-19 Syndrome, Fatigue
- What is being tested?
- Dietary intervention to mitigate Post-Acute COVID-19 Syndrome
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 50 years or older
- No known active infectious disease (COVID-19 or other).
- Participant diagnosed with long-COVID/ post- acute COVID-19 syndrome (PACS) /ICD-10-CM codes U09.9
- Moderate/severe fatigue Brief Fatigue Inventory (BFI)≥4
- Poor diet quality assessed by the short Healthy Eating Index (HEI)<70
Who cannot join
- Participants with a home oxygen requirement or requiring chronic ventilator support
- Participants diagnosed with diabetes who do not have a recent HbA1c level or with HbA1c > 9%
- Participants diagnosed with Congestive Heart Failure (CHF New York Heart Association) > class 2
- Participants with dietary restrictions due to medication use that affects blood clotting, such as Warfarin or other reasons.
- 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.
- Participants diagnosed with uncontrolled hypertension that will be defined as:
Show all 17Show fewer
- Systolic blood pressure consistently equal to or higher than 190 mmHg.
- Diastolic blood pressure consistently equal to or higher than 110 mmHg.
- Participants with a recent history of hypertensive crisis (severe elevation in blood pressure requiring immediate medical intervention), regardless of current blood pressure levels.
- Participants with diet restrictions or allergies that can affect adherence to the diet, such as allergy to fish or shellfish.
- Participation in another trial in which active intervention is being received.
- Participants with active drug or alcohol use/dependence that would interfere with adherence to the study.
- Participants scheduled for surgical procedures within the next 6 months.
- Participants diagnosed with active cancer.
- Participants diagnosed with liver diseases.
- Participants diagnosed with kidney-related conditions, including Chronic Kidney Disease (CKD) > stage 3.
- Below the age of 50 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Galya Bigman
About this study
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
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:
Read more
- Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate fatigue symptoms in adults with PACS?
- 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.
Read the detailed description
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:
- 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.
- 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
- Post-Acute COVID-19 Syndrome, Fatigue
- Being tested
- Dietary intervention to mitigate Post-Acute COVID-19 Syndrome, Attention Control
- Keywords
- COVID, long-COVID, DIET
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention to mitigate Post-Acute COVID-19 SyndromeOther
As it was described in the arm/group descriptions.
Attention ControlOther
As it was described in the arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention to mitigate Post-Acute COVID-19 Syndrome | Experimental | 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. Receives: Other: Dietary intervention to mitigate Post-Acute COVID-19 Syndrome |
| Attention Control | Other | 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. Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue will be assessed by the brief fatigue inventory (BFI)
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)
Physical Function
Physical Function will be measured by the Short Physical Performance Battery(SPPB)
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start12 May 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galya Bigman, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977179
- Sponsor's protocol ID
- HP-00106745
- Acronym
- Long-COVIDiet
- Status last verified
- Jun 2026
- First submitted
- 28 Jul 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bigman G, Rusu ME, Shelawala N, Sorkin JD, Beamer BA, Ryan AS. A Comprehensive Scoping Review on Diet and Nutrition in Relation to Long COVID-19 Symptoms and Recovery. Nutrients. 2025 May 26;17(11):1802. doi: 10.3390/nu17111802.
PubMed 40507071
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05977179
- Acronym / sponsor ID
- Long-COVIDiet / HP-00106745
- Conditions
- Post-Acute COVID-19 Syndrome, Fatigue
- Keywords
- COVID, long-COVID, DIET
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate fatigue symptoms in adults with PACS?
- 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.
Detailed description
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:
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention to mitigate Post-Acute COVID-19 Syndrome | Experimental | Other: Dietary intervention to mitigate Post-Acute COVID-19 SyndromeDuring 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. |
| Attention Control | Other | Other: Attention ControlParticipants 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. |
Who may qualify
- Ages
- 50 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 50 years or older
- No known active infectious disease (COVID-19 or other).
- Participant diagnosed with long-COVID/ post- acute COVID-19 syndrome (PACS) /ICD-10-CM codes U09.9
- Moderate/severe fatigue Brief Fatigue Inventory (BFI)≥4
- Poor diet quality assessed by the short Healthy Eating Index (HEI)<70
Key exclusion criteria (17 listed)
- Participants with a home oxygen requirement or requiring chronic ventilator support
- Participants diagnosed with diabetes who do not have a recent HbA1c level or with HbA1c > 9%
- Participants diagnosed with Congestive Heart Failure (CHF New York Heart Association) > class 2
- Participants with dietary restrictions due to medication use that affects blood clotting, such as Warfarin or other reasons.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention to mitigate Post-Acute COVID-19 SyndromeAs it was described in the arm/group descriptions. | Other | Dietary intervention to mitigate Post-Acute COVID-19 Syndrome |
| Attention ControlAs it was described in the arm/group descriptions. | Other | Attention Control |
Primary outcome
Fatigue
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)
Fatigue will be assessed by the brief fatigue inventory (BFI)
Physical Function
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)
Physical Function will be measured by the Short Physical Performance Battery(SPPB)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Results publication: PubMed 40507071Bigman G, Rusu ME, Shelawala N, Sorkin JD, Beamer BA, Ryan AS. A Comprehensive Scoping Review on Diet and Nutrition in Relation to Long COVID-19 Symptoms and Recovery. Nutrients. 2025 May 26;17(11):1802. doi: 10.3390/nu17111802.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention to mitigate Post-Acute COVID-19 Syndrome in people with Post-Acute COVID-19 Syndrome and Fatigue, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galya Bigman, PhD (4109168191, gbigman@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05977179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.