Effect of Nutritional Supplements on Clinical Outcomes in Patients With Prediabetes and Obesity

Study Overview
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Brief Summary
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This study aims to improve blood glucose and weight in patients with prediabetes and obesity through health education, nutritional supplement interventions, clinical evaluation, and close clinical follow-up.100 patients with prediabetes with obesity were randomly divided into 2 groups: life intervention group, nutritional supplement intervention group. All enrolled participants were recommended for routine diabetes lifestyle education according to the Expert Consensus on Prediabetes Intervention in Adults in China. The duration of the intervention was 3 months. The investigators aimed to compare the differences in weight, glycosylated hemoglobin, lipids and other indicators of the two groups of included populations before and after the intervention. In addition, the investigators are to explore the effects of nutritional supplement interventions on glycolipid metabolism and body weight in prediabetes with obesity.

Official Title
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Effect of Nutritional Supplements (Ivital Control) on Clinical Outcomes in Patients With Prediabetes and Obesity：a Randomized Controlled Study

Conditions
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PreDiabetes, Obesity

Intervention / Treatment
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* Dietary Supplement: Ivital Control
* Behavioral: lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: According to the American Diabetes Society (ADA) 2010 standard: meet one of the following (1) fasting blood glucose at 100 mg/dl to 125 mg/dl; (2) sugar load 2h blood glucose at 140 mg/dl to 199 mg/dl; (3) glycosylated hemoglobin in 5.7% to 6.4% 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: People with confirmed diabetes 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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: life intervention group nutritional supplement intervention group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: life intervention group<br>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. | Behavioral: lifestyle intervention<br>* Patients will receive lifestyle interventions.<br>|
| Experimental: nutritional supplement intervention group<br>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. | Dietary Supplement: Ivital Control<br>* 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.<br>* Other names: Product specifications: 460g (46g*10);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportions of participants regressing back to normal glucose level | The normal glucose level was defined as FPG < 6.1 mmol/L and 2hPG < 7.8 mmol/L during the OGTT. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in HbA1c | change in HbA1c | 3 months | 
| body weight | changes in body weight | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PreDiabetes, Obesity, Glycosylated hemoglobin, weight