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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; PreDiabetes
• Intervention / Treatment: Behavioral: lifestyle intervention; Dietary supplement: Ivital Control

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Li, Bachelor of Medicine degree; Phone Number: 8613757426626; Email: lilyningbo@163.com

Study Locations

• China
  • Ningbo, China
    • Recruiting
    • Ningbo First Hospital
    • Contact: Li Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Behavioral: lifestyle intervention; Patients will receive lifestyle interventions.
Experimental: 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.	Dietary supplement: 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.; Other Names: Produced by Fresenius Kabi; Chocolate flavor; Product specifications: 460g (46g*10)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in waist circumference	anthropometric parameters	3 months
changes in hip circumference	anthropometric parameters	3 months
changes in neck circumference	anthropometric parameters	3 months
changes in visceral fat area	body composition	3 months
changes in body fat percentage	body composition	3 months
changes in lean mass	body composition	3 months
blood lipids	changes in LDL-cholesterol, HDL-cholesterol	3 months
changes in triglyceride level (blood lipids)	changes in triglyceride	3 months

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; weight; PreDiabetes; Glycosylated hemoglobin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperglycemia; Obesity; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 2021-R037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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