Benefits of Nutritional Ingredients for Type 2 Diabetes
NCT ID: NCT06327711
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2024-09-30
2025-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CHO Blend
Group will consume a ready to feed CHO blend beverage
Control: CHO Blend
2 servings as a snack or between meals morning and evening
CHO Blend plus AN100
Group will consume a ready to feed CHO plus AN100 beverage
Experimental: CHO Blend plus AN100
2 servings as a snack or between meals morning and evening
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Control: CHO Blend
2 servings as a snack or between meals morning and evening
Experimental: CHO Blend plus AN100
2 servings as a snack or between meals morning and evening
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
40 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Nutrition
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Suzette Pereira
Role: STUDY_CHAIR
Abbott Nutrition
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kent State University
Kent, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BL77
Identifier Type: -
Identifier Source: org_study_id