Diabetes type2NCT06327711
Benefits of Nutritional Ingredients for Type 2 Diabetes
A study testing Experimental: CHO Blend plus AN100 in people with Diabetes type2, run by Abbott Nutrition at 1 site in United States.
Trial summary
This is a prospective randomized, double-blinded, parallel design study to evaluate the benefits of long-term consumption of two experimental blends of liquid supplements. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes type2
- What is being tested?
- Experimental: CHO Blend plus AN100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2024to Oct 2025
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has type 2 diabetes
- Taking a maximum of 3 oral anti-diabetic drugs, one must be Metformin.
- HbA1c ≥ 6.5% and ≤ 9.5% based on blood sample obtained at Screening Visit
- BMI > 27.0 and < 35.0 kg/m2
- Weight is stable for the two months prior to Baseline visit
- Either male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to Baseline Visit
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- If on chronic medication type and dose were constant for at least two months prior to the baseline Visit, and medication will continue throughout the study
- Willingness to follow the protocol as described, including consumption of study product and completing any forms/questionnaires needed throughout the study
- Four-week washout period between completion of a previous research study that required ingestion of any study food or drug and start in current study
- The participant is willing to refrain from taking non-study diabetes-specific oral nutritional formulas during the study
Who cannot join
- Use of exogenous insulin or GLP1 agonists
- Follows a non-typical eating pattern such as very low carbohydrate diet
- Pregnant or attempting to conceive
- Confirmed type 1 diabetes and/or history of diabetic ketoacidosis
- Current infection inpatient surgery or received systemic corticosteroid treatment in last 3 months; or received antibiotics in last 3 weeks
- Has current active malignant disease or treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma
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- Significant cardiovascular event within 6 months prior or history of congestive heart failure
- End-stage organ failure or is post-organ transplant
- Current or history of renal disease, on dialysis or severe gastroparesis
- Diagnosed hepatic disease or late stage liver fibrosis. Participants with prevalent angina will not be excluded.
- Had bariatric surgery including gastric balloon; history of gastrointestinal disease or intestinal surgery
- Chronic, contagious, infectious disease
- Eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or any other conditions that may interfere with study product consumption or compliance with study protocol procedures
- Taking any herbals, dietary supplements, or medications during the past four weeks prior to baseline visit that could profoundly affect blood glucose, body weight, muscle, metabolism, appetite or microbiome incretin mimetics, other drugs indicated for weight loss, cannabis, glucocorticoids, probiotic supplements). Those who have stopped using such supplements/ medications for ≥4 weeks prior to baseline need not be excluded).
- Using diabetes-specific oral nutritional supplements(s), defined as more than one eating occasion per week within the past 4 weeks (those users who can stop using such products for ≥4 weeks before baseline visit need not be excluded)
- Actively enrolled in a weight loss program
- Clotting or bleeding disorders
- Blood or blood-related diseases
- Blood transfusion within the last 3 weeks
- Allergic or intolerant to any ingredient found in the study products
- Engages in strenuous exercise duration of 1 hour or longer, 3 or more times per week
- Participates in another study that has not been approved as a concomitant study by Abbott Nutrition
- Participant has skin lesions hyperhidrosis, eczema, psoriasis, scarring, tattoos, redness, infection or edema at the application sites that could interfere with device placement or accuracy of interstitial glucose measurements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof of Concept Study: Long-term Benefits of a Blend of Nutritional Ingredients for Type 2 Diabetes
This is a prospective randomized, double-blinded, parallel design study to evaluate the benefits of long-term consumption of two experimental blends of liquid supplements.
- Conditions
- Diabetes type2
- Being tested
- Control: CHO Blend, Experimental: CHO Blend plus AN100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control: CHO BlendOther
2 servings as a snack or between meals morning and evening
Experimental: CHO Blend plus AN100Other
2 servings as a snack or between meals morning and evening
| Study group | Role | What they receive |
|---|---|---|
| CHO Blend | Active comparator | Group will consume a ready to feed CHO blend beverage Receives: Other: Control: CHO Blend |
| CHO Blend plus AN100 | Experimental | Group will consume a ready to feed CHO plus AN100 beverage Receives: Other: Experimental: CHO Blend plus AN100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matsuda Index
Change in insulin sensitivity
Measured: Baseline to week 12
Fasted Glucose
Change in fasted glucose levels overtime
Measured: Baseline week 4, week 8 and week 12
Fasted Insulin
Change in fasted insulin levels overtime
Measured: Baseline week 4, week 8 and week 12
Secondary outcomes (10)
Body Weight
Changes in body weight
Measured: Baseline up to 12 weeks
Body Composition Measurements
Changes in bio electrical impendence analysis (BIA)
Measured: Baseline up to 12 weeks
Continuous Glucose Monitoring
Change in glycemic variability
Measured: Baseline, week 1 to week 2, week 11 and 12
Glycated Hemoglobin
Change in hemoglobin A1c
Measured: Baseline week 4, week 8 and week 12
Resting Energy Expenditure (REE)
Changes in REE
Measured: Baseline to week 12
Microbiome - Fecal
Changes in fecal microbiome
Measured: Baseline week 2, week 4, week 8 and week 12
Microbiome - Saliva
Changes in saliva microbiome
Measured: Baseline week 2, week 4, week 8 and week 12
Waist Circumference
Changes in waist circumference
Measured: Baseline up to 12 weeks
Hip Circumference
Changes in hip circumstance
Measured: Baseline up to 12 weeks
Conicity Index
Changes in conicity index
Measured: Baseline up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study startSep 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Change in study scope
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type2Studies 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
- Model description
- 2 groups, non-crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzette Pereira, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327711
- Sponsor's protocol ID
- BL77
- Status last verified
- Dec 2024
- First submitted
- 7 Feb 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study: Long-term Benefits of a Blend of Nutritional Ingredients for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06327711
- Acronym / sponsor ID
- BL77
- Conditions
- Diabetes type2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in study scope
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 25 Mar 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.
This is a prospective randomized, double-blinded, parallel design study to evaluate the benefits of long-term consumption of two experimental blends of liquid supplements.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups, non-crossover
| Arm | Type | Receives |
|---|---|---|
| CHO Blend | Active comparator | Other: Control: CHO BlendGroup will consume a ready to feed CHO blend beverage |
| CHO Blend plus AN100 | Experimental | Other: Experimental: CHO Blend plus AN100Group will consume a ready to feed CHO plus AN100 beverage |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has type 2 diabetes
- Taking a maximum of 3 oral anti-diabetic drugs, one must be Metformin.
- HbA1c ≥ 6.5% and ≤ 9.5% based on blood sample obtained at Screening Visit
- BMI > 27.0 and < 35.0 kg/m2
- Weight is stable for the two months prior to Baseline visit
Key exclusion criteria (23 listed)
- Use of exogenous insulin or GLP1 agonists
- Follows a non-typical eating pattern such as very low carbohydrate diet
- Pregnant or attempting to conceive
- Confirmed type 1 diabetes and/or history of diabetic ketoacidosis
- Current infection inpatient surgery or received systemic corticosteroid treatment in last 3 months; or received antibiotics in last 3 weeks
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 |
|---|---|---|
| Control: CHO Blend2 servings as a snack or between meals morning and evening | Other | CHO Blend |
| Experimental: CHO Blend plus AN1002 servings as a snack or between meals morning and evening | Other | CHO Blend plus AN100 |
Primary outcome
Matsuda Index
Time frame: Baseline to week 12
Change in insulin sensitivity
Fasted Glucose
Time frame: Baseline week 4, week 8 and week 12
Change in fasted glucose levels overtime
Fasted Insulin
Time frame: Baseline week 4, week 8 and week 12
Change in fasted insulin levels overtime
10 secondary outcomes
Body Weight
Time frame: Baseline up to 12 weeks
Body Composition Measurements
Time frame: Baseline up to 12 weeks
Continuous Glucose Monitoring
Time frame: Baseline, week 1 to week 2, week 11 and 12
Glycated Hemoglobin
Time frame: Baseline week 4, week 8 and week 12
Resting Energy Expenditure (REE)
Time frame: Baseline to week 12
Microbiome - Fecal
Time frame: Baseline week 2, week 4, week 8 and week 12
Microbiome - Saliva
Time frame: Baseline week 2, week 4, week 8 and week 12
Waist Circumference
Time frame: Baseline up to 12 weeks
Hip Circumference
Time frame: Baseline up to 12 weeks
Conicity Index
Time frame: Baseline up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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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.
Suzette Pereira 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 Experimental: CHO Blend plus AN100 in people with Diabetes type2, run by Abbott Nutrition at 1 site in United States.
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 10 inclusion and 23 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: withdrawn, as of the sponsor's last update on 4 Dec 2024. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Matsuda Index (time frame: Baseline to week 12). The study lists 3 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 4 Dec 2024.