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Behavioural Intervention

Low Carbohydrate Diet for Post-COVID Syndrome

N/A

Recruiting

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one month

Awards & highlights

Study Summary

This trial is looking at the effects of dietary interventions with a low-carb and high-fat diet, plus a medical food, to help reduce symptoms of long COVID.

Who is the study for?

Adults who had COVID-19 at least 2 months ago and are experiencing ongoing neurological or physical symptoms typical of long COVID, such as fatigue, loss of smell, or shortness of breath. Participants must not be hospitalized or have conditions like chronic kidney disease stage III+, heart failure, liver cirrhosis, autoimmune diseases, active infections, certain eating disorders or be on specific medications that could interfere with the study.Check my eligibility

What is being tested?

The trial is testing a low-carbohydrate diet intervention aimed at reducing blood glucose and increasing blood BHB levels to improve long COVID symptoms. This includes avoiding sugars and starches while consuming healthy fats and proteins along with a medical food supplement. The control group will receive standard therapy without dietary changes.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort due to dietary changes such as constipation or diarrhea. There might also be an adjustment period with symptoms like headaches or lethargy as the body adapts to lower carbohydrate intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one month

This trial's timeline: 3 weeks for screening, Varies for treatment, and one month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cardiovascular risk

Feasibility of dietary intervention

Improved uric acid metabolism

+5 more

Secondary outcome measures

Improvement of long-COVID syndrome signs Measurement of aerobic capacity

Improvement of long-COVID syndrome signs Measurement of change in body weight

Improvement of long-COVID syndrome signs: Gastrointestinal review of systems

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low CarbohydrateExperimental Treatment1 Intervention

-Low-Carbohydrate Diet Intervention:Patients will receive a study kit. The kit will contain the following: Instruction sheet containing medical food instructions and food journal and a web link to the weekly online journal A 30-day supply of the medical food, KetoCitra, developed by Santa Barbara Nutrients, Inc. KetoCitra® is a ready-to-mix powder to be dissolved in water and taken twice per day with meals. KetoCitra® contains BHB, citrate, and a blend of minerals (potassium, calcium, magnesium) and is flavored with natural lemon flavor and stevia natural sweetener. KetoCitra® is sugar- and sodium-free and is intended to support the metabolic switch aimed for with the low-carbohydrate diet by providing exogenous BHB. (Package insert)

Group II: ControlActive Control1 Intervention

-Usual diet.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,268 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this experiment currently underway?

"Clinicaltrials.gov shows that this experiment is actively attempting to recruit patients, having been initially posted and updated on September 14th 2023."

Answered by AI

How many participants is the study currently accommodating?

"Affirmative. Information displayed on clinicaltrials.gov affirms that this research, which was initially posted on September 14th 2023 is currently recruiting participants. 50 volunteers must be sourced from 1 medical facility to complete the study."

Answered by AI

What is the aim of this medical research?

"The principal aim of this 30-day trial is to increase uric acid metabolism. Secondary goals include ameliorating the symptoms of long COVID such as respiratory health, gastrointestinal discomfort, muscle and joint pain, mental wellbeing, skin changes and fever/chills. Additionally, there are measurements for kidney function (serum creatinine/eGFR) proteinuria/cystatin C into the CKD-EPI equation), body weight change and urine alterations (color amount frequency)."

Answered by AI