Clinical trial NCT06327711: Benefits of Nutritional Ingredients for Type 2 Diabetes
Official title: Proof of Concept Study: Long-term Benefits of a Blend of Nutritional Ingredients for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes type2
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2024-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups, non-crossover
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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
* 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

Primary outcomes:
measure: Matsuda Index
timeFrame: Baseline to week 12
measure: Fasted Glucose
timeFrame: Baseline week 4, week 8 and week 12
measure: Fasted Insulin
timeFrame: Baseline week 4, week 8 and week 12
Secondary outcomes:
measure: Body Weight
timeFrame: Baseline up to 12 weeks
measure: Body Composition Measurements
timeFrame: Baseline up to 12 weeks
measure: Continuous Glucose Monitoring
timeFrame: Baseline, week 1 to week 2, week 11 and 12
measure: Glycated Hemoglobin
timeFrame: Baseline week 4, week 8 and week 12
measure: Resting Energy Expenditure (REE)
timeFrame: Baseline to week 12
measure: Microbiome - Fecal
timeFrame: Baseline week 2, week 4, week 8 and week 12
measure: Microbiome - Saliva
timeFrame: Baseline week 2, week 4, week 8 and week 12
measure: Waist Circumference
timeFrame: Baseline up to 12 weeks
measure: Hip Circumference
timeFrame: Baseline up to 12 weeks
measure: Conicity Index
timeFrame: Baseline up to 12 weeks
Other outcomes:
measure: Blood Pressure
timeFrame: Baseline week 4, week 8 and week 12
measure: Accelerometry Data
timeFrame: Baseline to week 12
measure: Diabetes Distress Scale
timeFrame: Baseline to week 12
measure: Dietary Intake
timeFrame: Baseline to week 12
measure: Blood biomarkers - inflammation
timeFrame: Time Frame: Baseline to week 12
measure: Urine biomarkers - inflammation
timeFrame: Time Frame: Baseline to week 12
Locations:
city: Kent
country: United States
facility: Kent State University
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Suzette Pereira
role: STUDY_CHAIR
References: