Effect of Nutritional Supplements on Clinical Outcomes in Patients With Prediabetes and Obesity
NCT ID: NCT05273840
Last Updated: 2022-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2021-06-11
2022-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
2. nutritional supplement intervention group
PREVENTION
NONE
Study Groups
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life intervention group
On the basis of the patient's original eating habits, basic dietary and lifestyle guidance is given to the patients until the end of the visit.
lifestyle intervention
Patients will receive lifestyle interventions.
nutritional supplement intervention group
On the basis of the patient's original eating habits, basic dietary and lifestyle guidance is given, and at the same time, nutritional supplements(Ivital Control) are given to instead a meal per day. 2 bags once a day until the end of the visit.
Ivital Control
Patients in the intervention group will take 2 sachets of nutritional supplements(Ivital Control) once a day in lieu of one meal, besides receiving lifestyle interventions.
Interventions
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Ivital Control
Patients in the intervention group will take 2 sachets of nutritional supplements(Ivital Control) once a day in lieu of one meal, besides receiving lifestyle interventions.
lifestyle intervention
Patients will receive lifestyle interventions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≥ 25 and ≤ 35kg/m2
* Have lived locally for at least half a year and have a fixed residence
* No other clinical trials were participated in in the 3 months prior to the trial
* Mental health, being able to take care of oneself in life
Exclusion Criteria
* Weight change of more than 10% over the past 3 months
* Pregnant or lactating women, men and women planning to become pregnant within two years, or unwilling and unable to use contraception during the study period (women only)
* People who are allergic to the ingredients of nutritional supplements
* Those who have lost weight by any medication (including appetite suppressants such as fluprophenylpropanine, progesterone, laxatives, etc., and diet pills with various Traditional Chinese medicine ingredients) or surgery in the past 3 months
* Patients who have received medical treatment for the following diseases in the past 3 months: diabetes, cholecystitis, peptic ulcer, inflammatory bowel disease, acute urinary tract infection, hyperthyroidism, etc., or patients with chronic gastrointestinal diseases with symptoms of nausea, vomiting and diarrhea in the past month
* Suffer from severe organic diseases such as cancer, coronary heart disease, myocardial infarction and stroke
* Presence of pituitary-adrenal axis dysfunction; secondary obesity due to other diseases (e.g., Cushing syndrome, hypothyroidism, etc.)
18 Years
70 Years
ALL
No
Sponsors
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Ningbo No. 1 Hospital
OTHER
Responsible Party
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Locations
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Ningbo First Hospital
Ningbo, , China
Countries
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Central Contacts
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Facility Contacts
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Li Li
Role: primary
Other Identifiers
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2021-R037
Identifier Type: -
Identifier Source: org_study_id
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