Benefits of Nutritional Ingredients for Type 2 Diabetes

Trial details

Who runs it

Abbott Nutrition

Trial code

NCT06327711

Record updated

2024. december 4.

Original description

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 full original descriptionShow less

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.

Inclusion: 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; 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: Current infection inpatient surgery or received systemic corticosteroid treatment in last 3 months; or received antibiotics in last 3 weeks; Significant cardiovascular event within 6 months prior or history of congestive heart failure; 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); Participates in another study that has not been approved as a concomitant study by Abbott Nutrition; Confirmed type 1 diabetes and/or history of diabetic ketoacidosis; Has current active malignant disease or treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma; 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; Clotting or bleeding disorders; Blood or blood-related diseases; Allergic or intolerant to any ingredient found in the study products; 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); 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; Use of exogenous insulin or GLP1 agonists; Follows a non-typical eating pattern such as very low carbohydrate diet; Pregnant or attempting to conceive; Actively enrolled in a weight loss program; Blood transfusion within the last 3 weeks; Engages in strenuous exercise duration of 1 hour or longer, 3 or more times per week.

ClinicalTrials.gov NCT06327711