Benefits of Nutritional Ingredients for Type 2 Diabetes

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes type2
• Intervention / Treatment: Other: Control: CHO Blend; Other: Experimental: CHO Blend plus AN100

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Kent, Ohio, United States, 44242
      • Kent State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CHO Blend; Group will consume a ready to feed CHO blend beverage	Other: Control: CHO Blend; 2 servings as a snack or between meals morning and evening
Experimental: CHO Blend plus AN100; Group will consume a ready to feed CHO plus AN100 beverage	Other: Experimental: CHO Blend plus AN100; 2 servings as a snack or between meals morning and evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Matsuda Index	Change in insulin sensitivity	Baseline to week 12
Fasted Glucose	Change in fasted glucose levels overtime	Baseline week 4, week 8 and week 12
Fasted Insulin	Change in fasted insulin levels overtime	Baseline week 4, week 8 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Changes in body weight	Baseline up to 12 weeks
Body Composition Measurements	Changes in bio electrical impendence analysis (BIA)	Baseline up to 12 weeks
Continuous Glucose Monitoring	Change in glycemic variability	Baseline, week 1 to week 2, week 11 and 12
Glycated Hemoglobin	Change in hemoglobin A1c	Baseline week 4, week 8 and week 12
Resting Energy Expenditure (REE)	Changes in REE	Baseline to week 12
Microbiome - Fecal	Changes in fecal microbiome	Baseline week 2, week 4, week 8 and week 12
Microbiome - Saliva	Changes in saliva microbiome	Baseline week 2, week 4, week 8 and week 12
Waist Circumference	Changes in waist circumference	Baseline up to 12 weeks
Hip Circumference	Changes in hip circumstance	Baseline up to 12 weeks
Conicity Index	Changes in conicity index	Baseline up to 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Systolic and Diastolic	Baseline week 4, week 8 and week 12
Accelerometry Data	Change in accelerometer daily activities	Baseline to week 12
Diabetes Distress Scale	Participant assessed 29 questions rated from 1 to 5 were higher number if less favorable	Baseline to week 12
Dietary Intake	Energy and macronutrient intake calculated from participant reported diary	Baseline to week 12
Blood biomarkers - inflammation	Change in protein marker of inflammation such as CRP	Time Frame: Baseline to week 12
Urine biomarkers - inflammation	Change in protein marker of inflammation such as CRP	Time Frame: Baseline to week 12

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Suzette Pereira, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: BL77

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No