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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention to mitigate Post-Acute COVID-19 Syndrome | Other | As it was described in the arm/group descriptions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Fatigue will be assessed by the brief fatigue inventory (BFI) | 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) | Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial) |
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Inclusion Criteria:
Exclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Galya Bigman, PhD | Contact | 4109168191 | gbigman@som.umaryland.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore | Recruiting | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40507071 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| Attention Control | Other | As it was described in the arm/group descriptions. |
|
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |