Diabetes type2
Conditions
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.
Interventions
OTHERControl: CHO Blend
2 servings as a snack or between meals morning and evening
OTHERExperimental: CHO Blend plus AN100
2 servings as a snack or between meals morning and evening
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
2 groups, non-crossover
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Matsuda Index | Baseline to week 12 | Change in insulin sensitivity |
| Fasted Insulin | Baseline week 4, week 8 and week 12 | Change in fasted insulin levels overtime |
| Fasted Glucose | Baseline week 4, week 8 and week 12 | Change in fasted glucose levels overtime |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin | Baseline week 4, week 8 and week 12 | Change in hemoglobin A1c |
| Resting Energy Expenditure (REE) | Baseline to week 12 | Changes in REE |
| Microbiome - Fecal | Baseline week 2, week 4, week 8 and week 12 | Changes in fecal microbiome |
| Microbiome - Saliva | Baseline week 2, week 4, week 8 and week 12 | Changes in saliva microbiome |
| Waist Circumference | Baseline up to 12 weeks | Changes in waist circumference |
| Hip Circumference | Baseline up to 12 weeks | Changes in hip circumstance |
| Conicity Index | Baseline up to 12 weeks | Changes in conicity index |
| Body Weight | Baseline up to 12 weeks | Changes in body weight |
| Body Composition Measurements | Baseline up to 12 weeks | Changes in bio electrical impendence analysis (BIA) |
| Continuous Glucose Monitoring | Baseline, week 1 to week 2, week 11 and 12 | Change in glycemic variability |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood biomarkers - inflammation | Time Frame: Baseline to week 12 | Change in protein marker of inflammation such as CRP |
| Urine biomarkers - inflammation | Time Frame: Baseline to week 12 | Change in protein marker of inflammation such as CRP |
| Dietary Intake | Baseline to week 12 | Energy and macronutrient intake calculated from participant reported diary |
| Diabetes Distress Scale | Baseline to week 12 | Participant assessed 29 questions rated from 1 to 5 were higher number if less favorable |
| Accelerometry Data | Baseline to week 12 | Change in accelerometer daily activities |
| Blood Pressure | Baseline week 4, week 8 and week 12 | Systolic and Diastolic |
Countries
United States
Outcome results
None listed