Clinical TrialNCT05635539
Weight Loss in Patients With COVID-19 and Influenza in Comorbidity With NCDs: a Pilot Prospective Clinical Trial
A study testing "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet in people with Clinical Trial, run by University Medical Center, Kazakhstan at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Clinical Trial
- What is being tested?
- "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Aug 2020to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet
- Keywords
- COVID-19, Influenza, Non-Communicable Diseases (NCDs), fast weight loss
- Medical subject headings
- COVID-19, Influenza, Human, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-dietDietary supplement
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| patients with COVID | Experimental | 27 patients with COVID in comorbidity with NCDs as T2D, hypertension, and NASH Receives: 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 Receives: Dietary Supplement: "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline at 6 Weeks
weight loss during 14 days
kg
Measured: Change from Baseline at 14 days
C-reactive protein
mg/L
Measured: Change from Baseline at 6 Weeks
Secondary outcomes (7)
fasting blood glucose
mmol/L
Measured: Change from Baseline at 6 Weeks
glycosylated hemoglobin A1c
percent
Measured: Change from Baseline at 6 Weeks
blood insulin
nU/L
Measured: Change from Baseline at 6 Weeks
systolic/diastolic blood pressures
mmHg
Measured: Change from Baseline at 6 Weeks
blood lipids
mmol/L
Measured: Change from Baseline at 6 Weeks
alanine aminotransferase and aspartate aminotransferase
U/L
Measured: Change from Baseline at 6 Weeks
chest computed tomography scan
image
Measured: Change from Baseline at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Aug 2020
- Primary completion30 Apr 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 27 patients with COVID and 35 patients with Influenza
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center, Kazakhstan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuat Oshakbayev, University Medical Center, Kazakhstan
- Investigators
- Alaty N Nabiyev, Dr., Study director, University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635539
- Sponsor's protocol ID
- AP05135241
- Status last verified
- Apr 2024
- First submitted
- 30 Nov 2022
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38744929
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Life Expectancy in Patients With Metabolic Syndrome After Weight Loss: a Comparative Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05635539
- Acronym / sponsor ID
- AP05135241
- Conditions
- Clinical Trial
- Keywords
- COVID-19, Influenza, Non-Communicable Diseases (NCDs), fast weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Medical Center, KazakhstanUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 27 patients with COVID and 35 patients with Influenza
| Arm | Type | Receives |
|---|---|---|
| patients with COVID | Experimental | Dietary Supplement: "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet27 patients with COVID in comorbidity with NCDs as T2D, hypertension, and NASH |
| patients with Influenza | Experimental | Dietary Supplement: "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet35 patients with Influenza in comorbidity with NCDs as T2D, hypertension, and NASH |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- patients with acute respiratory failure and assisted ventilation requirement
- respiratory rate ≥ 30 times per minute
- oxygen saturation ≤ 93% by finger oximetry at resting status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-dietAlso: very-low-calorie-dietcalorie 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. | Dietary supplement | patients with COVID, patients with Influenza |
Primary outcome
Clinic and infectious tests for COVID and Influenza
Time frame: 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
Time frame: Change from Baseline at 14 days
kg
C-reactive protein
Time frame: Change from Baseline at 6 Weeks
mg/L
7 secondary outcomes
fasting blood glucose
Time frame: Change from Baseline at 6 Weeks
glycosylated hemoglobin A1c
Time frame: Change from Baseline at 6 Weeks
blood insulin
Time frame: Change from Baseline at 6 Weeks
systolic/diastolic blood pressures
Time frame: Change from Baseline at 6 Weeks
blood lipids
Time frame: Change from Baseline at 6 Weeks
alanine aminotransferase and aspartate aminotransferase
Time frame: Change from Baseline at 6 Weeks
chest computed tomography scan
Time frame: Change from Baseline at 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Derived from this study: PubMed 38744929Oshakbayev 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaty N Nabiyev, Dr. study director
University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet in people with Clinical Trial, run by University Medical Center, Kazakhstan at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinic and infectious tests for COVID and Influenza (time frame: Change from Baseline at 6 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05635539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.