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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05273840
• Other study ID #: 2021-R037
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2021
• Est. completion date: November 2022

Study information

• Verified date: June 2022
• Source: Ningbo No. 1 Hospital
• Contact: Li Li, Bachelor of Medicine degree
• Phone: 8613757426626
• Email: lilyningbo[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Glucose Intolerance
• Obesity
• PreDiabetes
• Prediabetic State

Intervention

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.

Behavioral:
• lifestyle intervention
Patients will receive lifestyle interventions.

Locations

Country	Name	City	State
China	Ningbo First Hospital	Ningbo

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	changes in waist circumference	anthropometric parameters	3 months
Other	changes in hip circumference	anthropometric parameters	3 months
Other	changes in neck circumference	anthropometric parameters	3 months
Other	changes in visceral fat area	body composition	3 months
Other	changes in body fat percentage	body composition	3 months
Other	changes in lean mass	body composition	3 months
Other	blood lipids	changes in LDL-cholesterol, HDL-cholesterol	3 months
Other	changes in triglyceride level (blood lipids)	changes in triglyceride	3 months
Primary	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	change in HbA1c	change in HbA1c	3 months
Secondary	body weight	changes in body weight	3 months