NCT04622722

Efficacy and Safety of Diabetes-specific Formula in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Hypothesis: the diabetes-specific formula Nutren diabetes provides better postprandial glucose control in patients with type 2 diabetes when compared to the isocaloric diet.

Detailed description

This study is an open label, randomized controlled cross-over study Research objectives: 1. To study the efficacy of diabetes-specific formula (Nutren Diabetes) in comparison with an isocaloric diet in the aspect of postprandial blood glucose and insulin response (baseline, 30, 60 and 120 minute). 2. To study the safety and tolerance of a diabetes-specific formula compared with an isocaloric diet in patients with type 2 diabetes mellitus Statistical analysis method 1. Descriptive statistics: categorical data will be summarized as number and percentage, continuous data with normal distribution will be presented as means and standard deviations, and continuous data with non-normal distribution will be summarized as median, minimum and maximum. 2. Inferential statistics: Repeated Measure ANOVA from analyzing the difference of means from measuring fasting glucose and insulin more than two times. 3. Inferential statistics: Paired T-Test or Wilcoxon Matched pairs Signed Rank Test derived by analyzing the comparison between the means of two dependent groups. 4. Report of the difference between two categories by the difference of means with 95% Confidence Interval 5. Number of participant (subjects) and criteria for participation 30 participants by calculation formula of Frison and Pocock (1992) with STATA program.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
OTHER	Nutren Diabetes	Nutren Diabetes provides energy at 360 kcal per 360 ml
OTHER	Isocaloric	Isocaloric diet One carton of soy milk (250 ml) and bologna sandwiches (two slices of bread) with mayonnaise

Timeline

• Start date: 2018-08-22
• Primary completion: 2020-05-16
• Completion: 2020-05-16
• First posted: 2020-11-10
• Last updated: 2023-10-03

Locations

1 site across 1 country: Thailand