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New treatment option for Post-Acute COVID-19 Syndrome
Official title Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome
ClinicalTrials.gov ID: NCT05977179
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 94
You may be able to join if
- 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
You likely can't join if
- 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...
- Participants diagnosed with uncontrolled hypertension that will be defined as:
See the full eligibility criteria
- 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
- 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...
- Participants diagnosed with uncontrolled hypertension that will be defined as:
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 94 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.