Clinical Trial
Conditions
Keywords
COVID-19, Influenza, Non-Communicable Diseases (NCDs), fast weight loss
Brief summary
The goal of this study was to evaluate the effects of the fast weight loss on clinic and laboratory inflammation profile, metabolic profile, reactive oxygen species (ROS) and body composition in patients with COVID and Influenza in comorbidity with NCDs. Primary endpoints: Clinic/infectious/inflammation tests for COVID and Influenza; weight loss during 14 days. Secondary endpoints: fasting blood glucose, HbA1c, blood insulin; systolic/diastolic BP; blood lipids; ALT, AST, chest CT-scan.
Detailed description
Study Design. A 6-week, open, pilot prospective clinical trial with the intention-to-treat principle. Participants: The study enrolled 72 adult people (38 women) aged from 25 to 80 years with moderate-to-severe cases COVID and Influenza in comorbidity with NCDs as T2D, hypertension, and NASH. All patients with the ARDs had in comorbidity with one or more NCDs. All patients refused for pharmacology therapy due to: either previous unsuccessful drug results; or an antimicrobial resistance profile; or drug allergy; or reluctance to take medication; or iatrogenic fear (iatrophobia); or a rich failed experience in drug treatment; and NASH. All the patients were admitted into the out-patient department in 3-5 days after illness onset. The study was carried out in the Republic of Kazakhstan from November, 2020, through July, 2022 at University Medical Center (Astana) and ANADETO medical center.
Interventions
DIETARY_SUPPLEMENTAnalimentary detoxication (ANADETO) weight loss based on very-low-calorie-diet
calorie restriction to 50-100 kcal/day with fat-free vegetables (tomatoes and cucumbers) with mandatory salt intake to 5-6 gr/day, hot water drinking 1000-1500 ml/day, walking at least 2,000 steps/day after normalized body temperature, and sexual self-restraint. The walking provided to promote of blood circulation and decrease in metabolic intoxication. The weight loss method lasted 14 days. Then the patients followed for 4-week a diet where they ate one meal a day without any food restriction.
Sponsors
University Medical Center, Kazakhstan
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
27 patients with COVID and 35 patients with Influenza
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* written informed consent form; * patients with fever * patients refused for pharmacology therapy * weight loss treatment for 12-14 days and +4 weeks follow-up (total 6 weeks)
Exclusion criteria
* patients with acute respiratory failure and assisted ventilation requirement * respiratory rate ≥ 30 times per minute * oxygen saturation ≤ 93% by finger oximetry at resting status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinic and infectious tests for COVID and Influenza | Change from Baseline at 6 Weeks | COVID was diagnosed primarily by direct detection of SARS-CoV-2 RNA by nucleic acid amplification tests with a real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay. To diagnosis of the flu was used a RT-PCR test called the Flu SC2 Multiplex Assay. |
| weight loss during 14 days | Change from Baseline at 14 days | kg |
| C-reactive protein | Change from Baseline at 6 Weeks | mg/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| systolic/diastolic blood pressures | Change from Baseline at 6 Weeks | mmHg |
| blood lipids | Change from Baseline at 6 Weeks | mmol/L |
| fasting blood glucose | Change from Baseline at 6 Weeks | mmol/L |
| chest computed tomography scan | Change from Baseline at 14 days | image |
| alanine aminotransferase and aspartate aminotransferase | Change from Baseline at 6 Weeks | U/L |
| glycosylated hemoglobin A1c | Change from Baseline at 6 Weeks | percent |
| blood insulin | Change from Baseline at 6 Weeks | nU/L |
Countries
Kazakhstan
Outcome results
None listed