Weight Loss in Patients With COVID-19 and Influenza in Comorbidity With NCDs: a Pilot Prospective Clinical Trial

University Medical Center, Kazakhstan62 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Clinical Trial

Interventions

"Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-dietDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Kuat Pernekulovich Oshakbayev

Astana, Kazakhstan

Outcomes

Primary Outcomes

Clinic and infectious tests for COVID and Influenza

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.