Diabetes MellitusFIBER-BP-DMNCT07504380
Fiber-Enriched, Sodium-Controlled Enteral Formula for Glycemia and Blood Pressure in Tube-Fed Residents With Diabetes
A study of Diabetes Mellitus, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Diabetes Mellitus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 May 2015to 6 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20-85 years
- Diagnosed with diabetes mellitus (HbA1c ≥ 6%)
- Receiving tube feeding for at least 3 months
- Clinically stable condition
Who cannot join
- Terminal cancer
- Liver cirrhosis
- Severe renal failure or uremia
- Lactose intolerance
- Any condition deemed unsuitable by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- Fiber-Enriched, Sodium-Controlled Enteral Formula
- Keywords
- Enteral nutrition, dietary fiber, sodium intake, blood pressure, glycemic status, long-term care, tube feeding
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Enteral Nutrition Formula Intervention | Experimental | Participants receive a fiber-enriched, sodium-controlled enteral nutrition formula as their sole nutritional intake for 3 months. Receives: Dietary Supplement: Fiber-Enriched, Sodium-Controlled Enteral Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 3 months, and 4 months
Secondary outcomes (20)
Aspartate aminotransferase (AST)
Aspartate aminotransferase (AST) will be measured in units per liter (U/L), with lower values indicating better liver function.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, and 4 months
Serum sodium
Serum sodium will be measured in millimoles per liter (mmol/L).
Measured: Baseline, 3 months, and 4 months
Serum potassium
Serum potassium will be measured in millimoles per liter (mmol/L).
Measured: Baseline, 3 months, and 4 months
Serum chloride
Serum chloride will be measured in millimoles per liter (mmol/L).
Measured: Baseline, 3 months, and 4 months
Serum calcium
Serum calcium will be measured in milligrams per deciliter (mg/dL).
Measured: Baseline, 3 months, and 4 months
Serum phosphorus
Serum phosphorus will be measured in milligrams per deciliter (mg/dL).
Measured: Baseline, 3 months, and 4 months
Serum magnesium
Serum magnesium will be measured in milligrams per deciliter (mg/dL).
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, and 4 months
Urinary sodium
Urinary sodium will be measured in millimoles per liter (mmol/L), reflecting sodium balance and intake.
Measured: Baseline, 3 months, and 4 months
Urine osmolality
Urine osmolality will be measured in milliosmoles per kilogram (mOsm/kg), reflecting urine concentration.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start4 May 2015
- Primary completion3 Sep 2015
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suh-Ching, Yang, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504380
- Sponsor's protocol ID
- TMU-IRB-20150436
- Acronym
- FIBER-BP-DM
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07504380
- Acronym / sponsor ID
- FIBER-BP-DM / TMU-IRB-20150436
- Conditions
- Diabetes Mellitus
- Keywords
- Enteral nutrition, dietary fiber, sodium intake, blood pressure, glycemic status, long-term care, tube feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 4 May 2015 (actual)
- Primary completion
- 3 Sep 2015 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enteral Nutrition Formula Intervention | Experimental | Dietary Supplement: Fiber-Enriched, Sodium-Controlled Enteral FormulaParticipants receive a fiber-enriched, sodium-controlled enteral nutrition formula as their sole nutritional intake for 3 months. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 20-85 years
- Diagnosed with diabetes mellitus (HbA1c ≥ 6%)
- Receiving tube feeding for at least 3 months
- Clinically stable condition
Key exclusion criteria (5 listed)
- Terminal cancer
- Liver cirrhosis
- Severe renal failure or uremia
- Lactose intolerance
- Any condition deemed unsuitable by investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiber-Enriched, Sodium-Controlled Enteral FormulaA standardized enteral nutrition formula enriched with dietary fiber and formulated with controlled sodium content, providing approximately 1500 kcal/day. | Dietary supplement | Enteral Nutrition Formula Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
20 secondary outcomes
Aspartate aminotransferase (AST)
Time frame: Baseline, 3 months, and 4 months
Alanine aminotransferase (ALT)
Time frame: Baseline, 3 months, and 4 months
Blood urea nitrogen (BUN)
Time frame: Baseline, 3 months, and 4 months
Serum creatinine
Time frame: Baseline, 3 months, and 4 months
Gamma-glutamyl transferase (GGT)
Time frame: Baseline, 3 months, and 4 months
Total bilirubin
Time frame: Baseline, 3 months, and 4 months
Lactate dehydrogenase (LDH)
Time frame: Baseline, 3 months, and 4 months
Creatine phosphokinase (CPK)
Time frame: Baseline, 3 months, and 4 months
Serum sodium
Time frame: Baseline, 3 months, and 4 months
Serum potassium
Time frame: Baseline, 3 months, and 4 months
Serum chloride
Time frame: Baseline, 3 months, and 4 months
Serum calcium
Time frame: Baseline, 3 months, and 4 months
Serum phosphorus
Time frame: Baseline, 3 months, and 4 months
Serum magnesium
Time frame: Baseline, 3 months, and 4 months
Complete blood count (CBC)
Time frame: Baseline, 3 months, and 4 months
Urinary urea nitrogen (UUN)
Time frame: Baseline, 3 months, and 4 months
Urinary sodium
Time frame: Baseline, 3 months, and 4 months
Urine osmolality
Time frame: Baseline, 3 months, and 4 months
Urinalysis
Time frame: Baseline, 3 months, and 4 months
Bowel movement frequency
Time frame: Baseline, 3 months, and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetes Mellitus, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic blood pressure (time frame: baseline, 3 months, and 4 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.