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

A Study of Life Expectancy in Patients With Metabolic Syndrome After Weight Loss: a Comparative Randomized Clinical Trial.

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 Overview

• Status: Completed
• Conditions: Clinical Trial
• Intervention / Treatment: Dietary supplement: "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kazakhstan
  • Astana, Kazakhstan, 010000
    • Kuat Pernekulovich Oshakbayev

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with COVID; 27 patients with COVID in comorbidity with NCDs as T2D, hypertension, and NASH	Dietary supplement: "Analimentary 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.; Other Names: very-low-calorie-diet
Experimental: patients with Influenza; 35 patients with Influenza in comorbidity with NCDs as T2D, hypertension, and NASH	Dietary supplement: "Analimentary 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.; Other Names: very-low-calorie-diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline at 6 Weeks
weight loss during 14 days	kg	Change from Baseline at 14 days
C-reactive protein	mg/L	Change from Baseline at 6 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting blood glucose	mmol/L	Change from Baseline at 6 Weeks
glycosylated hemoglobin A1c	percent	Change from Baseline at 6 Weeks
blood insulin	nU/L	Change from Baseline at 6 Weeks
systolic/diastolic blood pressures	mmHg	Change from Baseline at 6 Weeks
blood lipids	mmol/L	Change from Baseline at 6 Weeks
alanine aminotransferase and aspartate aminotransferase	U/L	Change from Baseline at 6 Weeks
chest computed tomography scan	image	Change from Baseline at 14 days

Collaborators and Investigators

• Sponsor: University Medical Center, Kazakhstan
• Investigators: Study Director: Alaty N Nabiyev, Dr., University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Influenza; COVID-19; Non-Communicable Diseases (NCDs); fast weight loss
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: AP05135241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators will make data available to any investigator/reviewer on their own request, so that the personal privacy of our patients cannot be compromised.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No