Diabetes-Specific Formula in Individuals With Type 2 Diabetes

NCT04303754 | Completed

• 1 other identifier: BL45
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted using a randomized, controlled, crossover design with three treatments. The purpose of the study is to determine the effects of diabetes-specific formula on glycemic control in individuals with type 2 diabetes.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Postprandial blood glucose

  Positive area under the curve (AUC) for blood glucose concentration over 0 to 240 minutes.

  4 hours

Secondary Outcomes (2)

• Postprandial insulin

  4 hours

• Appetite

  4 hours

Study Arms (3)

Diabetes-Specific Formula

EXPERIMENTAL

Diabetes-Specific Formula

Other: Diabetes-Specific Formula

Bread and Spread

EXPERIMENTAL

White bread with spread

Other: Bread with Spread

Rice Porridge

EXPERIMENTAL

Rice Porridge

Other: Rice Porridge

Interventions

Diabetes-Specific Formula OTHER

Other: Diabetes Specific Formula

Diabetes-Specific Formula

Bread with Spread OTHER

Other: White Bread with Spread

Bread and Spread

Rice Porridge OTHER

Other: Rice Porridge

Rice Porridge

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21 and ≤ 65 years.
• Participant has type 2 diabetes as evidenced by use of oral antihyperglycemic medication(s), except for DPP-4 inhibitors, with constant dose for at least two months prior to screening and baseline visit. Participant is able to maintain medication number, type and dose throughout the duration of study.
• Participant with a BMI \> 18.5 and ≤ 35.0 kg/m2.
• Participant is weight stable (has maintained current body weight within 3 kg) for the two months prior to the screening visit.
• Male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). If female is of childbearing potential, is practicing one of the following methods of birth control (and will continue through the duration of the study):
• Condoms, sponge, diaphragm or intrauterine device;
• Oral or parenteral contraceptives for 3 months prior to screening visit;
• Vasectomized partner;
• Total abstinence from sexual intercourse.
• If the participant is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, the dosage was constant for at least two months prior to screening and baseline visit. Participant is able to maintain medication number, type and dose throughout the duration of study.
• Participant is willing to follow protocol as described, including consumption of study product per protocol and completing any forms needed throughout the study.
• Participant has at least a two-week washout period between completion of a previous research study that required ingestion of any study food or drug and their start in the current study.
• Participant is willing to refrain from taking non-study diabetes-specific formulas over the entire course of the study.
• Participant has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.

You may not qualify if:

• Participant has a screening HbA1c level \<7% or ≥ 10%.
• Participant uses exogenous insulin or GLP-1 agonists or DPP-4 inhibitors for glucose control.
• Participant has confirmed type 1 diabetes and/or had history of diabetic ketoacidosis.
• Participant has current infection (requiring medication), inpatient surgery or received systemic corticosteroid treatment (with the exception of inhaled (includes nasal), topical, and ophthalmic steroids) in the last 3 months; or received antibiotics in the last 3 weeks.
• Participant has active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
• Participant has significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure.
• Participant has end stage organ failure (such as end stage renal disease) or was post organ transplant.
• Participant has a history of renal disease or severe gastroparesis.
• Participant has current hepatic disease.
• Participant has had bariatric surgery including gastric balloon; history of gastrointestinal disease (e.g., Crohn's, colitis, celiac) or intestinal surgery that can interfere with consumption or digestion or absorption of study product.
• Participant has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis A, B or C, or HIV.
• Participant has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the principal investigator or study physician.
• Participant is taking any herbals, dietary supplements, or medications, other than allowed anti-hyperglycemic medications, during the past four weeks prior to screening visit that could profoundly affect (in the opinion of the principal investigator) blood glucose or appetite (examples include orlistat, contrive, qsymia, belviq, incretins, cannabis).
• Participant uses diabetes-specific formula(s), (e.g. Glucerna, Nestle Nutren Diabetes, Kalbe Diabetasol, Appeton Nutrition Wellness 60+ Diabetic, ForSure, Penta Sure DM, Resurge DM, Diben, Diasip, etc.) defined as more than one eating occasion per week in the last three months.
• Participant has clotting or bleeding disorders. The use of Plavix® or a similar anticoagulant drug with no reported difficulty during blood draws is allowed and participant is able to maintain medication number, type and dose throughout the duration of study.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

Hospital Universiti Kebangsaan Malaysia

Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Bread

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Agnes Siew Ling Tey, Ph.D.

  Abbott Nutrition

  STUDY CHAIR

• Norlaila Mustafa, MD.

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: March 11, 2020
• Study Start: June 24, 2020
• Primary Completion: October 19, 2022
• Study Completion: October 19, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)