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

NCT ID: NCT05635539

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-07-31

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.

Conditions

Clinical Trial

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients with COVID

27 patients with COVID in comorbidity with NCDs as T2D, hypertension, and NASH

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_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.

patients with Influenza

35 patients with Influenza in comorbidity with NCDs as T2D, hypertension, and NASH

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_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.

Interventions

"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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

very-low-calorie-diet

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center, Kazakhstan

OTHER

Sponsor Role: lead

Responsible Party

Kuat Oshakbayev

a principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaty N Nabiyev, Dr.

Role: STUDY_DIRECTOR

University Medical Center

Locations

Kuat Pernekulovich Oshakbayev

Astana, , Kazakhstan

Countries

Kazakhstan

References

Oshakbayev K, Durmanova A, Zhankalova Z, Idrisov A, Bedelbayeva G, Gazaliyeva M, Nabiyev A, Tordai A, Dukenbayeva B. Weight loss treatment for COVID-19 in patients with NCDs: a pilot prospective clinical trial. Sci Rep. 2024 May 14;14(1):10979. doi: 10.1038/s41598-024-61703-1.

Reference Type: DERIVED

PMID: 38744929 (View on PubMed)

Other Identifiers

AP05135241

Identifier Type: -

Identifier Source: org_study_id