DiabetesNCT06632002
Diabetes-specific Formulas on Nutritional Outcomes in Individuals With Diabetes Who Require Nutritional Support
A study testing DSF1 and DSF2 in people with Diabetes, run by Abbott Nutrition at 1 site in Taiwan.
Trial summary
The study aims to demonstrate the non-inferiority of diabetes-specific formula (DSF)1 compared to DSF2 in individuals with type 1 diabetes, type 2 diabetes or prediabetes and who are at nutritional risk. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Diabetes
- What is being tested?
- DSF1 and DSF2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jan 2025to 7 May 2026
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Has any of the following types of diabetes:
- Type 1 diabetes
- Type 2 diabetes
- Prediabetes
- Has MNA-SF score of ≤ 11
Show all 15Show fewer
- Serum albumin less than 4.0 g/dL
- Energy or protein intake less than recommended
- BMI less than 30.0 kg/m2
- Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the study
- Female of childbearing potential to use an effective method of birth control
- Chronic medication type and dose to be constant and maintained throughout the study
- Willing to follow the protocol throughout the study
- At least a two-week washout period between the completion of a previous research study and start in current study
- Willing to refrain from taking non-study diabetes-specific formula over the course of the study.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Has a screening HbA1c level less than 5.0% or ≥ 10%
- Has a current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks
- Has active malignancy within the last 5 years
- Has significant cardiovascular event within 6 months prior to the study or history of congestive heart failure
- Has end-stage organ failure or is post-organ transplant
Show all 20Show fewer
- Has current or history of renal disease or on dialysis or severe gastroparesis
- Has current hepatic disease
- Has a recent acute infection, physiologic stress or trauma within 1 month prior to the study
- Has had bariatric surgery including gastric balloon; history of gastrointestinal disease or intestinal surgery that can interfere with consumption or digestion or absorption of study product
- Has a chronic, contagious, infectious disease
- Has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study procedures
- Taking any herbals, dietary supplements or medications during the past 4 weeks prior to the study
- Using diabetes-specific formula(s) or oral nutritional supplement formula(s) in more than one eating occasion per week within the past 3 months
- Has clotting or bleeding disorders
- Has blood or blood-related diseases
- Has received blood transfusion within the last 3 weeks
- Has allergy or intolerance to the study product
- Anticipated poor compliance to the study as assessed by the Investigator
- Participates in another study that has not been approved as a concomitant study by Abbott Nutrition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Non-inferiority Trial of a New Diabetes-specific Formula Compared to an Existing Diabetes-specific Formula on Nutritional Outcomes in Individuals With Diabetes Who Require Nutritional Support
The study aims to demonstrate the non-inferiority of diabetes-specific formula (DSF)1 compared to DSF2 in individuals with type 1 diabetes, type 2 diabetes or prediabetes and who are at nutritional risk.
Read the detailed description
This is a randomized, double-blind, parallel, non-inferiority study. Eligible participants will be randomly allocated (at 1:1 ratio) to one of two groups: DSF1 (experimental group) or DSF2 (control group). Both groups will incorporate one serving of the DSF into their daily diet, in addition to receiving standard of care for diabetes. The total expected duration of the study is up to 104 days, including a run-in period of up to 14 days, followed by an intervention period of 90 days. At Day 1, participants will be randomized into one of the two groups (n = 50 per group): DSF1 or DSF2. Participants will start the intervention on Day 1 and complete the intervention on Day 90.
- Conditions
- Diabetes
- Being tested
- DSF1, DSF2, Standard of Care (SOC)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSF1Other
220 mL
DSF2Other
220 mL
Standard of Care (SOC)Other
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Experimental Product | Experimental | Not described Receives: Other: DSF1; Other: Standard of Care (SOC) |
| Control Product | Other | Not described Receives: Other: DSF2; Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum albumin
Change in serum albumin levels from baseline to Day 90
Measured: Study Day 1 to Day 90
Secondary outcomes (20)
Serum albumin
Serum albumin levels
Measured: Study Days 45 and 90
Malnutrition risk
Mini Nutritional Assessment - Short Form (MNA®-SF) a validated screening tool for identifying elderly persons who are at risk for malnutrition, or who are already malnourished. It classifies participants into one of three categories:
- Normal nutritional status/score =12 to 14 points,
- At risk of malnutrition/score = 8 to 11 points,
- Malnourished/score = 0 to 7 points. Minimum point = 0, Maximum points = 14. Lower score indicates worse outcome, i.e., at risk of malnutrition or malnourished.
Measured: Study Days 45 and 90
Malnutrition risk
Malnutrition Universal Screening Tool (MUST) is a widely used screening tool for malnutrition. It classifies participants into one of three nutrition status categories:
- Low risk/score = 0,
- Medium risk/score = 1,
- High risk/score ≥ 2. Minimum value = 0, Maximum value = 6. Higher score indicates worse outcome, i.e., increased risk of malnutrition.
Measured: Study Days 45 and 90
Serum prealbumin
Serum prealbumin levels
Measured: Study Days 45 and 90
Body weight
Body weight measured in kg
Measured: Study Days 45 and 90
Body mass index (BMI)
Calculated as weight (kg)/height (m)2
Measured: Study Days 45 and 90
Mid arm circumference
Mid arm circumference measured in cm
Measured: Study Days 45 and 90
Mid arm muscle circumference
Mid arm muscle circumference measured in cm
Measured: Study Days 45 and 90
Triceps skinfold thickness
Triceps skinfold thickness measured in mm
Measured: Study Days 45 and 90
Calf circumference
Calf circumference measured in cm
Measured: Study Days 45 and 90
Waist circumference
Waist circumference measured in cm
Measured: Study Days 45 and 90
Hip circumference
Hip circumference measured in cm
Measured: Study Days 45 and 90
Waist-to-hip-ratio
Waist-to-hip-ratio
Measured: Study Days 45 and 90
Hemoglobin A1c (HbA1c)
HbA1c levels
Measured: Study Days 45 and 90
Fasting plasma glucose
Fasting plasma glucose levels
Measured: Study Days 45 and 90
2-hour postprandial glucose
2-hour postprandial glucose levels
Measured: Study Days 45 and 90
Glycated albumin
Glycated albumin levels
Measured: Study Days 45 and 90
Triglycerides
Triglycerides levels
Measured: Study Days 45 and 90
High density lipoprotein (HDL) cholesterol
HDL cholesterol levels
Measured: Study Days 45 and 90
Low density lipoprotein (LDL) cholesterol
LDL cholesterol levels
Measured: Study Days 45 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start14 Jan 2025
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mandy Yen Ling Ow, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632002
- Sponsor's protocol ID
- BL80
- Status last verified
- Aug 2026
- First submitted
- 6 Oct 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Non-inferiority Trial of a New Diabetes-specific Formula Compared to an Existing Diabetes-specific Formula on Nutritional Outcomes in Individuals With Diabetes Who Require Nutritional Support
- ClinicalTrials.gov ID
- NCT06632002
- Acronym / sponsor ID
- BL80
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 8 Oct 2024 (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.
The study aims to demonstrate the non-inferiority of diabetes-specific formula (DSF)1 compared to DSF2 in individuals with type 1 diabetes, type 2 diabetes or prediabetes and who are at nutritional risk.
Detailed description
This is a randomized, double-blind, parallel, non-inferiority study. Eligible participants will be randomly allocated (at 1:1 ratio) to one of two groups: DSF1 (experimental group) or DSF2 (control group). Both groups will incorporate one serving of the DSF into their daily diet, in addition to receiving standard of care for diabetes. The total expected duration of the study is up to 104 days, including a run-in period of up to 14 days, followed by an intervention period of 90 days. At Day 1, participants will be randomized into one of the two groups (n = 50 per group): DSF1 or DSF2. Participants will start the intervention on Day 1 and complete the intervention on Day 90.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Product | Experimental | Other: DSF1, Other: Standard of Care (SOC) |
| Control Product | Other | Other: DSF2, Other: Standard of Care (SOC) |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Has any of the following types of diabetes:
- Has MNA-SF score of ≤ 11
- Serum albumin less than 4.0 g/dL
- Energy or protein intake less than recommended
Key exclusion criteria (20 listed)
- Has a screening HbA1c level less than 5.0% or ≥ 10%
- Has a current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks
- Has active malignancy within the last 5 years
- Has significant cardiovascular event within 6 months prior to the study or history of congestive heart failure
- Has end-stage organ failure or is post-organ transplant
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 |
|---|---|---|
| DSF1220 mL | Other | Experimental Product |
| DSF2220 mL | Other | Control Product |
| Standard of Care (SOC)Standard of care | Other | Control Product, Experimental Product |
Primary outcome
Serum albumin
Time frame: Study Day 1 to Day 90
Change in serum albumin levels from baseline to Day 90
20 secondary outcomes
Serum albumin
Time frame: Study Days 45 and 90
Malnutrition risk
Time frame: Study Days 45 and 90
Malnutrition risk
Time frame: Study Days 45 and 90
Serum prealbumin
Time frame: Study Days 45 and 90
Body weight
Time frame: Study Days 45 and 90
Body mass index (BMI)
Time frame: Study Days 45 and 90
Mid arm circumference
Time frame: Study Days 45 and 90
Mid arm muscle circumference
Time frame: Study Days 45 and 90
Triceps skinfold thickness
Time frame: Study Days 45 and 90
Calf circumference
Time frame: Study Days 45 and 90
Waist circumference
Time frame: Study Days 45 and 90
Hip circumference
Time frame: Study Days 45 and 90
Waist-to-hip-ratio
Time frame: Study Days 45 and 90
Hemoglobin A1c (HbA1c)
Time frame: Study Days 45 and 90
Fasting plasma glucose
Time frame: Study Days 45 and 90
2-hour postprandial glucose
Time frame: Study Days 45 and 90
Glycated albumin
Time frame: Study Days 45 and 90
Triglycerides
Time frame: Study Days 45 and 90
High density lipoprotein (HDL) cholesterol
Time frame: Study Days 45 and 90
Low density lipoprotein (LDL) cholesterol
Time frame: Study Days 45 and 90
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 20 Aug 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.
Mandy Yen Ling Ow, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSF1 and DSF2 in people with Diabetes, run by Abbott Nutrition 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 15 inclusion and 20 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 20 Aug 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?
Serum albumin (time frame: Study Day 1 to Day 90). 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 20 Aug 2026.