Fiber-Enriched, Sodium-Controlled Enteral Formula for Glycemia and Blood Pressure in Tube-Fed Residents With Diabetes (FIBER-BP-DM)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Fiber-Enriched, Sodium-Controlled Enteral Formula

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei
    • Taipei, Taipei, Taiwan, 11031
      • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enteral Nutrition Formula Intervention; 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; A standardized enteral nutrition formula enriched with dietary fiber and formulated with controlled sodium content, providing approximately 1500 kcal/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspartate aminotransferase (AST)	Aspartate aminotransferase (AST) will be measured in units per liter (U/L), with lower values indicating better liver function.	Baseline, 3 months, and 4 months
Alanine aminotransferase (ALT)	Alanine aminotransferase (ALT) will be measured in units per liter (U/L), with lower values indicating better liver function.	Baseline, 3 months, and 4 months
Blood urea nitrogen (BUN)	Blood urea nitrogen (BUN) will be measured in milligrams per deciliter (mg/dL), with lower values indicating better kidney function.	Baseline, 3 months, and 4 months
Serum creatinine	Serum creatinine will be measured in milligrams per deciliter (mg/dL), with lower values indicating better kidney function.	Baseline, 3 months, and 4 months
Gamma-glutamyl transferase (GGT)	Gamma-glutamyl transferase (GGT) will be measured in units per liter (U/L), with lower values indicating better liver function.	Baseline, 3 months, and 4 months
Total bilirubin	Total bilirubin will be measured in milligrams per deciliter (mg/dL), with lower values indicating better liver function.	Baseline, 3 months, and 4 months
Lactate dehydrogenase (LDH)	Lactate dehydrogenase (LDH) will be measured in units per liter (U/L), with values reflecting tissue injury.	Baseline, 3 months, and 4 months
Creatine phosphokinase (CPK)	Creatine phosphokinase (CPK) will be measured in units per liter (U/L), with higher values indicating muscle damage.	Baseline, 3 months, and 4 months
Serum sodium	Serum sodium will be measured in millimoles per liter (mmol/L).	Baseline, 3 months, and 4 months
Serum potassium	Serum potassium will be measured in millimoles per liter (mmol/L).	Baseline, 3 months, and 4 months
Serum chloride	Serum chloride will be measured in millimoles per liter (mmol/L).	Baseline, 3 months, and 4 months
Serum calcium	Serum calcium will be measured in milligrams per deciliter (mg/dL).	Baseline, 3 months, and 4 months
Serum phosphorus	Serum phosphorus will be measured in milligrams per deciliter (mg/dL).	Baseline, 3 months, and 4 months
Serum magnesium	Serum magnesium will be measured in milligrams per deciliter (mg/dL).	Baseline, 3 months, and 4 months
Complete blood count (CBC)	Complete blood count (CBC) will be performed using standard laboratory methods, including white blood cell count (WBC), red blood cell count (RBC), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and platelet count (PLT). Parameters will be reported in standard clinical units.	Baseline, 3 months, and 4 months
Urinary urea nitrogen (UUN)	Urinary urea nitrogen (UUN) will be measured in grams per day (g/day) or milligrams per deciliter (mg/dL), reflecting protein metabolism and nitrogen balance.	Baseline, 3 months, and 4 months
Urinary sodium	Urinary sodium will be measured in millimoles per liter (mmol/L), reflecting sodium balance and intake.	Baseline, 3 months, and 4 months
Urine osmolality	Urine osmolality will be measured in milliosmoles per kilogram (mOsm/kg), reflecting urine concentration.	Baseline, 3 months, and 4 months
Urinalysis	Urinalysis will be performed using standard laboratory methods, including specific gravity, pH, color, and clarity (clear or turbid), to assess general urinary characteristics.	Baseline, 3 months, and 4 months
Bowel movement frequency	Gastrointestinal tolerance will be assessed by bowel movement frequency, defined as the number of bowel movements per day.	Baseline, 3 months, and 4 months

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2015
• Primary Completion (Actual): September 3, 2015
• Study Completion (Actual): September 6, 2019

Study Registration Dates

• First Submitted: March 21, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: blood pressure; dietary fiber; sodium intake; Enteral nutrition; long-term care; tube feeding; glycemic status
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: TMU-IRB-20150436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No