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Completed

NCT Number: NCT07504380

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, 11031, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Systolic and diastolic blood pressure

    Time frame: baseline, 3 months, and 4 months

    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.

  2. Fasting blood glucose

    Time frame: Baseline, 3 months, and 4 months

    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.

  3. Glycated hemoglobin (HbA1c)

    Time frame: Baseline, 3 months, and 4 months

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

  4. Serum albumin

    Time frame: Baseline, 3 months, and 4 months

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

  5. Serum total protein

    Time frame: Baseline, 3 months, and 4 months

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

  6. Total cholesterol

    Time frame: Baseline, 3 months, and 4 months

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

  7. Triglycerides

    Time frame: Baseline, 3 months, and 4 months

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

  8. High-density lipoprotein cholesterol (HDL-C)

    Time frame: Baseline, 3 months, and 4 months

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

  9. Low-density lipoprotein cholesterol (LDL-C)

    Time frame: Baseline, 3 months, and 4 months

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

  10. Geriatric Nutritional Risk Index (GNRI)

    Time frame: Baseline, 3 months, and 4 months

    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.

  11. Subjective Global Assessment (SGA)

    Time frame: Baseline, 3 months, and 4 months

    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).

Secondary outcomes

  1. Aspartate aminotransferase (AST)

    Time frame: Baseline, 3 months, and 4 months

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

  2. Alanine aminotransferase (ALT)

    Time frame: Baseline, 3 months, and 4 months

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

  3. Blood urea nitrogen (BUN)

    Time frame: Baseline, 3 months, and 4 months

    Blood urea nitrogen (BUN) will be measured in milligrams per deciliter (mg/dL), with lower values indicating better kidney function.

  4. Serum creatinine

    Time frame: Baseline, 3 months, and 4 months

    Serum creatinine will be measured in milligrams per deciliter (mg/dL), with lower values indicating better kidney function.

  5. Gamma-glutamyl transferase (GGT)

    Time frame: Baseline, 3 months, and 4 months

    Gamma-glutamyl transferase (GGT) will be measured in units per liter (U/L), with lower values indicating better liver function.

  6. Total bilirubin

    Time frame: Baseline, 3 months, and 4 months

    Total bilirubin will be measured in milligrams per deciliter (mg/dL), with lower values indicating better liver function.

  7. Lactate dehydrogenase (LDH)

    Time frame: Baseline, 3 months, and 4 months

    Lactate dehydrogenase (LDH) will be measured in units per liter (U/L), with values reflecting tissue injury.

  8. Creatine phosphokinase (CPK)

    Time frame: Baseline, 3 months, and 4 months

    Creatine phosphokinase (CPK) will be measured in units per liter (U/L), with higher values indicating muscle damage.

  9. Serum sodium

    Time frame: Baseline, 3 months, and 4 months

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

  10. Serum potassium

    Time frame: Baseline, 3 months, and 4 months

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

  11. Serum chloride

    Time frame: Baseline, 3 months, and 4 months

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

  12. Serum calcium

    Time frame: Baseline, 3 months, and 4 months

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

  13. Serum phosphorus

    Time frame: Baseline, 3 months, and 4 months

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

  14. Serum magnesium

    Time frame: Baseline, 3 months, and 4 months

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

  15. Complete blood count (CBC)

    Time frame: Baseline, 3 months, and 4 months

    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.

  16. Urinary urea nitrogen (UUN)

    Time frame: Baseline, 3 months, and 4 months

    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.

  17. Urinary sodium

    Time frame: Baseline, 3 months, and 4 months

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

  18. Urine osmolality

    Time frame: Baseline, 3 months, and 4 months

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

  19. Urinalysis

    Time frame: Baseline, 3 months, and 4 months

    Urinalysis will be performed using standard laboratory methods, including specific gravity, pH, color, and clarity (clear or turbid), to assess general urinary characteristics.

  20. Bowel movement frequency

    Time frame: Baseline, 3 months, and 4 months

    Gastrointestinal tolerance will be assessed by bowel movement frequency, defined as the number of bowel movements per day.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Acronym: FIBER-BP-DM

Important dates

Study start
2015
Primary completion
2015
Study completion
2019
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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