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

NCT05635539 | Completed DMC

• 1 other identifier: AP05135241
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Trial

Keywords

COVID-19; Influenza; Non-Communicable Diseases (NCDs); fast weight loss

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• fasting blood glucose

  Change from Baseline at 6 Weeks

• glycosylated hemoglobin A1c

  Change from Baseline at 6 Weeks

• blood insulin

  Change from Baseline at 6 Weeks

• systolic/diastolic blood pressures

  Change from Baseline at 6 Weeks

• blood lipids

  Change from Baseline at 6 Weeks

Study Arms (2)

patients with COVID

EXPERIMENTAL

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

patients with Influenza

EXPERIMENTAL

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

Interventions

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

Also known as: very-low-calorie-diet

patients with COVID; patients with Influenza

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• patients with acute respiratory failure and assisted ventilation requirement
• respiratory rate ≥ 30 times per minute
• oxygen saturation ≤ 93% by finger oximetry at resting status

Sponsors & Collaborators

• University Medical Center, Kazakhstan: lead

Study Sites (1)

Kuat Pernekulovich Oshakbayev

Astana, 010000, Kazakhstan

Location

Related Publications (1)

• 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.

  PMID: 38744929 DERIVED

MeSH Terms

Conditions

COVID-19; Influenza, Human; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alaty N Nabiyev, Dr.

  University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: a principal investigator

Model Details: 27 patients with COVID and 35 patients with Influenza

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 2, 2022
• Study Start: August 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: July 31, 2022
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)