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

Sponsor

University Medical Center, Kazakhstan (Other)

Overall Status

Completed

CT.gov ID

NCT05635539

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clinical Trial	Dietary Supplement: "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

27 patients with COVID and 35 patients with Influenza27 patients with COVID and 35 patients with Influenza

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2020

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

Jul 31, 2022

Arms and Interventions

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

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

Other Names:

very-low-calorie-diet

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kuat Pernekulovich Oshakbayev	Astana		Kazakhstan	010000

Sponsors and Collaborators

University Medical Center, Kazakhstan

Investigators

Study Director: Alaty N Nabiyev, Dr., University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kuat Oshakbayev, a principal investigator, University Medical Center, Kazakhstan

ClinicalTrials.gov Identifier:

NCT05635539

Other Study ID Numbers:

AP05135241

First Posted:

Dec 2, 2022

Last Update Posted:

Dec 2, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kuat Oshakbayev, a principal investigator, University Medical Center, Kazakhstan

COVID-19

Influenza

Non-Communicable Diseases (NCDs)

fast weight loss

Additional relevant MeSH terms:

Weight Loss

Study Results

No Results Posted as of Dec 2, 2022