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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.
All study participants will be asked to attend a test session where their glycemic, insulinemic and satiety response to a test meal will be measured, followed by a seven-day washout period where they will not receive or consume any study meal during this period. This cycle will be repeated until all participants complete three test sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes-Specific Formula | Experimental | Diabetes-Specific Formula |
|
| Bread and Spread | Experimental | White bread with spread |
|
| Rice Porridge | Experimental | Rice Porridge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes-Specific Formula | Other | Other: Diabetes Specific Formula |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial blood glucose | Positive area under the curve (AUC) for blood glucose concentration over 0 to 240 minutes. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial insulin | Positive area under the curve (AUC) for blood insulin concentration over 0 to 240 minutes. | 4 hours |
| Appetite | Appetite (i.e. desire to eat, hunger, prospective consumption, and fullness) will be measured from 0 to 240 minutes using a 100-mm Visual Analogue Scale, anchored with "not at all" on the left side (0 mm) to "extremely" on the right side of the scale. |
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Inclusion Criteria:
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):
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnes Siew Ling Tey, Ph.D. | Abbott Nutrition | Study Chair |
| Norlaila Mustafa, MD. | Universiti Kebangsaan Malaysia Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universiti Kebangsaan Malaysia | Kuala Lumpur | 56000 | Malaysia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001939 | Bread |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Bread with Spread |
| Other |
Other: White Bread with Spread |
|
| Rice Porridge | Other | Other: Rice Porridge |
|
| 4 hours |
| D004700 | Endocrine System Diseases |