An interventional study of "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet in Clinical Trial, sponsored by University Medical Center, Kazakhstan. Completed at 1 site in Kazakhstan. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by University Medical Center, Kazakhstan · Not applicable, Interventional, and Treatment
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.
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 62 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University Medical Center, Kazakhstan is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Also known as: very-low-calorie-diet
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.
Time frame: Change from Baseline at 6 Weeks
weight loss during 14 days
kg
Time frame: Change from Baseline at 14 days
C-reactive protein
mg/L
Time frame: Change from Baseline at 6 Weeks
fasting blood glucose
mmol/L
Time frame: Change from Baseline at 6 Weeks
glycosylated hemoglobin A1c
percent
Time frame: Change from Baseline at 6 Weeks
blood insulin
nU/L
Time frame: Change from Baseline at 6 Weeks
systolic/diastolic blood pressures
mmHg
Time frame: Change from Baseline at 6 Weeks
blood lipids
mmol/L
Time frame: Change from Baseline at 6 Weeks
alanine aminotransferase and aspartate aminotransferase
U/L
Time frame: Change from Baseline at 6 Weeks
chest computed tomography scan
image
Time frame: Change from Baseline at 14 days
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Aug 2020 to primary completion in Apr 2022, 20 months.
Of 1,338 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 20 months is above that.
Counting every sponsor, half of 1,476 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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University Medical Center, Kazakhstan