NCT05273840

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ningbo No. 1 Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PreDiabetes
• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-11
• Primary completion: 2022-10-01
• Completion: 2022-11-01
• First posted: 2022-03-10
• Last updated: 2022-06-09

Locations

1 site across 1 country: China