Benefits of Nutritional Ingredients for Type 2 Diabetes

NCT06327711 | Withdrawn

• 1 other identifier: BL77
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes type2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Body Weight

  Baseline up to 12 weeks

• Body Composition Measurements

  Baseline up to 12 weeks

• Continuous Glucose Monitoring

  Baseline, week 1 to week 2, week 11 and 12

• Glycated Hemoglobin

  Baseline week 4, week 8 and week 12

• Resting Energy Expenditure (REE)

  Baseline to week 12

Other Outcomes (6)

• Blood Pressure

  Baseline week 4, week 8 and week 12

• Accelerometry Data

  Baseline to week 12

• Diabetes Distress Scale

  Baseline to week 12

Study Arms (2)

CHO Blend

ACTIVE COMPARATOR

Group will consume a ready to feed CHO blend beverage

Other: Control: CHO Blend

CHO Blend plus AN100

EXPERIMENTAL

Group will consume a ready to feed CHO plus AN100 beverage

Other: Experimental: CHO Blend plus AN100

Interventions

Control: CHO Blend OTHER

2 servings as a snack or between meals morning and evening

CHO Blend

Experimental: CHO Blend plus AN100 OTHER

2 servings as a snack or between meals morning and evening

CHO Blend plus AN100

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

Kent State University

Kent, Ohio, 44242, United States

Location

Study Officials

• Suzette Pereira

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 groups, non-crossover

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 25, 2024
• Study Start: September 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

US (1)