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

University Medical Center, Kazakhstan

Status: Completed

Conditions: Clinical Trial

Treatments: Dietary Supplement: "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05635539

AP05135241

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

patients with COVID

Experimental group

Description:

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

Treatment:

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

patients with Influenza

Experimental group

Description:

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

Treatment:

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