Back to resultsEffect of Nutritional Supplements on Clinical Outcomes in Patients With Prediabetes and Obesity
Primary Purpose
PreDiabetes, Obesity
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ivital Control
lifestyle intervention
Sponsored by
About this trial
This is an interventional prevention trial for PreDiabetes focused on measuring PreDiabetes, Obesity, Glycosylated hemoglobin, weight
Eligibility Criteria
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.)
Sites / Locations
- Ningbo First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
life intervention group
nutritional supplement intervention group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
change in HbA1c
change in HbA1c
body weight
changes in body weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05273840
Brief Title
Effect of Nutritional Supplements on Clinical Outcomes in Patients With Prediabetes and Obesity
Official Title
Effect of Nutritional Supplements (Ivital Control) on Clinical Outcomes in Patients With Prediabetes and Obesity：a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ningbo No. 1 Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Obesity
Keywords
PreDiabetes, Obesity, Glycosylated hemoglobin, weight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
life intervention group
nutritional supplement intervention group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
life intervention group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
nutritional supplement intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ivital Control
Other Intervention Name(s)
Produced by Fresenius Kabi, Chocolate flavor, Product specifications: 460g (46g*10)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
lifestyle intervention
Intervention Description
Patients will receive lifestyle interventions.
Primary Outcome Measure Information:
Title
the proportions of participants regressing back to normal glucose level
Description
The normal glucose level was defined as FPG < 6.1 mmol/L and 2hPG < 7.8 mmol/L during the OGTT.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
change in HbA1c
Description
change in HbA1c
Time Frame
3 months
Title
body weight
Description
changes in body weight
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
changes in waist circumference
Description
anthropometric parameters
Time Frame
3 months
Title
changes in hip circumference
Description
anthropometric parameters
Time Frame
3 months
Title
changes in neck circumference
Description
anthropometric parameters
Time Frame
3 months
Title
changes in visceral fat area
Description
body composition
Time Frame
3 months
Title
changes in body fat percentage
Description
body composition
Time Frame
3 months
Title
changes in lean mass
Description
body composition
Time Frame
3 months
Title
blood lipids
Description
changes in LDL-cholesterol, HDL-cholesterol
Time Frame
3 months
Title
changes in triglyceride level (blood lipids)
Description
changes in triglyceride
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Li, Bachelor of Medicine degree
Phone
8613757426626
Email
lilyningbo@163.com
Facility Information:
Facility Name
Ningbo First Hospital
City
Ningbo
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Li
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Nutritional Supplements on Clinical Outcomes in Patients With Prediabetes and Obesity
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