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

Taipei Medical University32 enrolled

Overview

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus

Interventions

Fiber-Enriched, Sodium-Controlled Enteral FormulaDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Taipei Medical University

Taipei, Taipei, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Aspartate aminotransferase (AST)

Aspartate aminotransferase (AST) will be measured in units per liter (U/L), with lower values indicating better liver function.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 3 months, and 4 months

Serum sodium

Serum sodium will be measured in millimoles per liter (mmol/L).

Time frame: Baseline, 3 months, and 4 months

Serum potassium

Serum potassium will be measured in millimoles per liter (mmol/L).

Time frame: Baseline, 3 months, and 4 months

Serum chloride

Serum chloride will be measured in millimoles per liter (mmol/L).

Time frame: Baseline, 3 months, and 4 months

Serum calcium

Serum calcium will be measured in milligrams per deciliter (mg/dL).

Time frame: Baseline, 3 months, and 4 months

Serum phosphorus

Serum phosphorus will be measured in milligrams per deciliter (mg/dL).

Time frame: Baseline, 3 months, and 4 months

Serum magnesium

Serum magnesium will be measured in milligrams per deciliter (mg/dL).

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 3 months, and 4 months

Urinary sodium

Urinary sodium will be measured in millimoles per liter (mmol/L), reflecting sodium balance and intake.

Time frame: Baseline, 3 months, and 4 months

Urine osmolality

Urine osmolality will be measured in milliosmoles per kilogram (mOsm/kg), reflecting urine concentration.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 3 months, and 4 months