NCT07504380

Fiber-Enriched, Sodium-Controlled Enteral Formula for Glycemia and Blood Pressure in Tube-Fed Residents With Diabetes

Effects of a Fiber-enriched, Sodium-controlled Enteral Formula on Glycemic Status and Blood Pressure in Tube-fed Long-term Care Residents With Diabetes: a Prospective Single-arm Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effects of a fiber-enriched, sodium-controlled enteral nutrition formula on glycemia, blood pressure, and nutritional status in long-term care residents with diabetes receiving tube feeding. Participants receive the enteral formula as their sole source of nutrition for 3 months, followed by a 1-month post-intervention follow-up period. Clinical outcomes including metabolic parameters, blood pressure, and safety indicators are assessed.

Detailed description

This prospective single-arm interventional study was conducted in long-term care residents with diabetes receiving tube feeding. The study protocol was approved by the Institutional Review Board of Taipei Medical University (TMU-IRB-201504036). Participants received a standardized enteral nutrition formula enriched with dietary fiber and designed with controlled sodium content, providing approximately 1500 kcal/day as the sole nutritional source. The intervention lasted for 3 months, followed by a 1-month observation period. Clinical assessments were conducted at baseline (M0), post-intervention (M1), and follow-up (M2). Outcomes included glycemic parameters (blood glucose, HbA1c), blood pressure, nutritional biomarkers (albumin, total protein), lipid profile, liver and kidney function, hematological indices, electrolyte levels, and gastrointestinal tolerance. This study aims to explore whether targeted nutritional composition, including fiber enrichment and sodium control, can contribute to maintaining metabolic and cardiovascular stability in tube-fed residents with diabetes.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fiber-Enriched, Sodium-Controlled Enteral Formula	A standardized enteral nutrition formula enriched with dietary fiber and formulated with controlled sodium content, providing approximately 1500 kcal/day.

Timeline

• Start date: 2015-05-04
• Primary completion: 2015-09-03
• Completion: 2019-09-06
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: Taiwan