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

NCT07504380 | Completed

• 1 other identifier: TMU-IRB-20150436
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Keywords

Enteral nutrition; dietary fiber; sodium intake; blood pressure; glycemic status; long-term care; tube feeding

Outcome Measures

Primary Outcomes (11)

• Systolic and diastolic blood pressure

  Blood pressure will be measured in millimeters of mercury (mmHg), including systolic and diastolic blood pressure. Lower values indicate better blood pressure control. Participants will be assessed at baseline, after the 3-month intervention period, and at 4 months during follow-up.

  baseline, 3 months, and 4 months

• Fasting blood glucose

  Fasting blood glucose will be measured in mg/dL, with lower values indicating better glycemic control. Participants will be assessed at baseline, after the 3-month intervention period, and at 4 months during follow-up.

  Baseline, 3 months, and 4 months

• Glycated hemoglobin (HbA1c)

  Glycated hemoglobin (HbA1c) will be measured as a percentage (%), with lower values indicating better glycemic control.

  Baseline, 3 months, and 4 months

• Serum albumin

  Serum albumin will be measured in grams per deciliter (g/dL), with higher values indicating better nutritional status.

  Baseline, 3 months, and 4 months

• Serum total protein

  Serum total protein will be measured in grams per deciliter (g/dL), with higher values indicating better nutritional status.

  Baseline, 3 months, and 4 months

• Total cholesterol

  Total cholesterol will be measured in milligrams per deciliter (mg/dL), with lower values indicating a better lipid profile.

  Baseline, 3 months, and 4 months

• Triglycerides

  Triglycerides will be measured in milligrams per deciliter (mg/dL), with lower values indicating a better lipid profile.

  Baseline, 3 months, and 4 months

• High-density lipoprotein cholesterol (HDL-C)

  High-density lipoprotein cholesterol (HDL-C) will be measured in milligrams per deciliter (mg/dL), with higher values indicating a better lipid profile.

  Baseline, 3 months, and 4 months

• Low-density lipoprotein cholesterol (LDL-C)

  Low-density lipoprotein cholesterol (LDL-C) will be measured in milligrams per deciliter (mg/dL), with lower values indicating a better lipid profile.

  Baseline, 3 months, and 4 months

• Geriatric Nutritional Risk Index (GNRI)

  The Geriatric Nutritional Risk Index (GNRI) is calculated using serum albumin and body weight relative to ideal body weight. Lower GNRI values indicate a higher risk of malnutrition.

  Baseline, 3 months, and 4 months

• Subjective Global Assessment (SGA)

  The Subjective Global Assessment (SGA) is a clinical tool used to assess nutritional status, classifying patients into categories (A: well-nourished, B: moderately malnourished, C: severely malnourished).

  Baseline, 3 months, and 4 months

Secondary Outcomes (20)

• Aspartate aminotransferase (AST)

  Baseline, 3 months, and 4 months

• Alanine aminotransferase (ALT)

  Baseline, 3 months, and 4 months

• Blood urea nitrogen (BUN)

  Baseline, 3 months, and 4 months

• Serum creatinine

  Baseline, 3 months, and 4 months

• Gamma-glutamyl transferase (GGT)

  Baseline, 3 months, and 4 months

Study Arms (1)

Enteral Nutrition Formula Intervention

EXPERIMENTAL

Participants receive a fiber-enriched, sodium-controlled enteral nutrition formula as their sole nutritional intake for 3 months.

Dietary Supplement: Fiber-Enriched, Sodium-Controlled Enteral Formula

Interventions

Fiber-Enriched, Sodium-Controlled Enteral Formula DIETARY_SUPPLEMENT

A standardized enteral nutrition formula enriched with dietary fiber and formulated with controlled sodium content, providing approximately 1500 kcal/day.

Enteral Nutrition Formula Intervention

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20-85 years
• Diagnosed with diabetes mellitus (HbA1c ≥ 6%)
• Receiving tube feeding for at least 3 months
• Clinically stable condition

You may not qualify if:

• Terminal cancer
• Liver cirrhosis
• Severe renal failure or uremia
• Lactose intolerance
• Any condition deemed unsuitable by investigators

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, Taipei, 11031, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Research Center of Geriatric Nutrition, Taipei Medical University

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: March 31, 2026
• Study Start: May 4, 2015
• Primary Completion: September 3, 2015
• Study Completion: September 6, 2019
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)