Clinical Trial on a Natural Compound to Improve Chronic Inflammation After SARS-CoV-2 Infection (NUTRACOVID)

Clinical Trial to Analyze the Effectiveness of a Natural Compound on Chronic Immune-mediated Inflammatory Status in Subjects Who Have Had SARS-CoV-2 Infection.

A controlled, randomized clinical trial is proposed to demonstrate the effectiveness of the experimental product in controlling hepato-pulmonary inflammation and neurovascular encephalic inflammation, which may constitute the etiopathogenic basis of persistent COVID. In addition, an individualized training program will be implemented for each participant in order to improve chronic symptoms and, consequently, their quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Long COVID
• Intervention / Treatment: Dietary supplement: Control placebo; Other: No Physical Exercise; Dietary supplement: Experimental Product; Other: Physical exercise

Detailed Description

Randomized, placebo-controlled, double-blind clinical trial with four parallel arms based on the product consumed (placebo or experimental product) and the performance of physical exercise (exercise or no exercise), designed to analyze the effectiveness of the product under investigation in reducing chronic immune-mediated inflammatory status in subjects who have had SARS-CoV-2 infection and present persistent symptoms 3 months after the onset of the infectious process.

The efficacy of the experimental product, consumed over a period of 4 months, will be determined in terms of reducing chronic inflammation and improving the quality of life of people suffering from this condition.

Clinical manifestations and chronic symptoms, quality of life, response to the individualized physical exercise program, and product safety will be taken into account.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francisco Javier López Román; Phone Number: 157 968278157; Email: jlroman@ucam.edu

Study Locations

• Spain
  • Murcia, Spain
    • UCAM HiTech, Sport & Health Innovation Hub
    • Contact: Francisco Javier López Román; Phone Number: 157 968278157; Email: jlroman@ucam.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects of both sexes.
• Subjects over 18 and under 70 years of age who have had a SARS-CoV-2 infection diagnosed by PDIA.
• Subjects with a history of SARS-CoV-2 infection who, three months after the onset of COVID-19, continue to experience symptoms lasting at least two months that cannot be explained by another cause. These symptoms may be newly developed after initial recovery from an acute COVID-19 episode or persist from the initial illness.
• No history of sequelae from a severe acute illness.

Exclusion Criteria:

• Subjects with an underlying disease that explains the clinical manifestations.
• Presence of chronic inflammatory diseases.
• Subjects with acute infections.
• Evidence of active thromboembolic disorder, defined as those receiving parenteral anticoagulant or thrombolytic treatment.
• Excessive alcohol consumption.
• Hypersensitivity or intolerance to any of the components of the study products.
• Use of any nutraceutical or dietary supplement.
• Severe or terminal illnesses.
• Subjects with a body mass index (BMI) over 32.
• Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Subjects in this group will consume a placebo product (maltodextrin) with the same organoleptic characteristics as the investigational product.	Dietary supplement: Control placebo; Product with identical characteristics to the experimental product.; Other: No Physical Exercise; During the study, subjects will only consume the product assigned to them in the randomization.
Experimental: Natural extract; Subjects in this group will consume the investigational product (experimental product composed of a combination of six natural extracts: grapefruit extract, apigenin, orange extract, luteolin, yerba mate extract, and olive leaf extract).	Other: No Physical Exercise; During the study, subjects will only consume the product assigned to them in the randomization.; Dietary supplement: Experimental Product; Supplement consisting of orange extract, apigenin, luteolin, yerba mate extract, grapefruit extract, and olive leaf extract.
Experimental: Physical exercise and consumption of experimental product; During the study, subjects must consume the experimental product and also follow a training program. A multi-component program will be carried out during the 4 months of product consumption. Sessions will last 60 minutes and will be held 2-3 times per week.	Dietary supplement: Experimental Product; Supplement consisting of orange extract, apigenin, luteolin, yerba mate extract, grapefruit extract, and olive leaf extract.; Other: Physical exercise; During the study, subjects will have to develop a training program. A multicomponent program will be carried out during the 4 months of product consumption. The sessions will last 60 minutes and will be held 2-3 times per week.
Placebo Comparator: Physical exercise and consumption of placebo product; During the study, subjects must consume the placebo product and also follow a training program. A multi-component program will be carried out during the 4 months of product consumption. Sessions will last 60 minutes and will be held 2-3 times per week.	Dietary supplement: Control placebo; Product with identical characteristics to the experimental product.; Other: Physical exercise; During the study, subjects will have to develop a training program. A multicomponent program will be carried out during the 4 months of product consumption. The sessions will last 60 minutes and will be held 2-3 times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunoinflammatory profile	Antibody assay for molecular biomarkers of the brain-liver-lung axis, blood-brain barrier, immunometabolic pathways, and immune-inflammatory and immuno-angiogenic cardiac remodeling.	Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 120 days of product intake.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical signs	The number of clinical manifestations, the type of manifestation, intensity according to the visual analog scale from 0 to 10, and duration of the symptomps. The clinical manifestations will be those felt by the subject.	It will be recorded twice, before starting the consumption of the product and before the end of consumption (120 days)
Short Form 12 Health Survey	Measured by SF-12 questionnaire. Scale 0-100%	It will be measured twice, once at baseline and at the end of the study after 120 days of consumption.
Sleep quality	Measured by Pittsburgh test	Progress will be measured after 120 days of consumption.
Sleep efficiency	Measured by accelerometry, with Actigraph wGT3X-BT	Progress will be measured after 120 days of consumption.
Fatigue	Measured with Fatigue Severity Scale (FSS). Rated on a 7-point Likert scale (1=strongly disagree, 7=strongly agree), a mean score of \(\ge 4\) typically indicates a moderate to high level of fatigue.	Progress will be measured after 120 days of consumption.
Dyspnea	It will be measured with Modified Medical Research Council (mMRC)	Progress will be measured after 120 days of consumption.
Depression	It will be measured with Beck Depression Inventory (BDI). Scores are calculated by adding up the responses to 21 items, with a range from 0 to 63, and scores are interpreted by severity levels: 0-13 (minimal), 14-19 (mild), 20-28 (moderate), and 29-63 (severe).	Progress will be measured after 120 days of consumption.
Anxiety	It will be measured with the State-Trait Anxiety Inventory (STAI). The STAI (State-Trait Anxiety Inventory) assesses transient (state) and stable (trait) anxiety using 40 items (20 per subscale) with a Likert-type score from 0 to 3. The total score per subscale ranges from 0 to 60, with higher scores indicating greater anxiety.	Progress will be measured after 120 days of consumption.
Hospital Anxiety and Depression	Measured with Hospital Anxiety and Depression Scale (HADS). It is a self-administered instrument with 14 items (7 for anxiety, 7 for depression) that is scored from 0 to 3, with a maximum total of 21 points per subscale. A score of 7 or less indicates normality, 8-10 indicates a borderline case, and 11 or above indicates a probable case of anxiety or depression.	Progress will be measured after 120 days of consumption.
Stress level	Perceived stress scale (PSS). Measures stress levels over the past month on a scale of 0 to 56. The higher the score, the greater the perceived stress. Typical interpretive ranges include low stress (0-13), moderate stress (14-26), and high stress (27-40+).	Progress will be measured after 120 days of consumption.
Cardiorespiratory fitness.	A submaximal test will be performed.	Progress will be measured after 120 days of consumption.
The Rate of Force Development	The Rate of Force Development (RFD) measures the speed at which the neuromuscular system generates maximum force in a short period of time (typically in the first 100-200 ms). It is a key indicator of explosive strength and power, vital in fast movements, jumps, sprints, and climbing.	Progress will be measured after 120 days of consumption.
Maximum Voluntary Isometric Contraction	Maximum Voluntary Isometric Contraction (MVIC) is the gold standard for measuring muscle strength, involving maximum contraction without joint movement (isometric). It is used to evaluate muscle activation using electromyography, comparing the percentage of effort against the muscle's maximum possible strength.	Progress will be measured after 120 days of consumption.
Body composition	It is a control variable. Measured by bioimpedance.	The test will be measured at baseline and after 16 weeks of consumption.
Liver safety variables	It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)	Hematological samples were taken before (day 0) and after consumption of the product (day 120) both in the control group and in the experimental group.
Adverse events	It will be evaluated only at the end of the study.	After 16 weeks of consumption.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Estimated): February 23, 2026
• Primary Completion (Estimated): July 6, 2026
• Study Completion (Estimated): August 3, 2026

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Nutraceutical; LongCOVID; Immune-inflammatory state
• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; Behavior; Post-Acute COVID-19 Syndrome; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: UCAMCFE-00038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No