Development of a Novel Cookie Formulation and Evaluation of Its Effects on Glycemic Control in Healthy Individuals

Chung Shan Medical University12 enrolled

Overview

This study will employ a randomized, open-label, crossover design to evaluate the glycemic response to newly developed cookie formulations. A total of 20 healthy adults aged 20-70 years with a body mass index (BMI) between 18.5 and 25 kg/m² will be recruited. Participants will first complete a standard reference test using 50 g of glucose solution, followed by random assignment to consume four to five different cookie formulations in separate test sessions with a washout period of at least three days between each test. All tests will be conducted after an overnight fast, and participants will consume the test food within 10 minutes. Capillary blood glucose levels will be measured at 0, 15, 30, 45, 60, 90, and 120 minutes after consumption. In addition, sensory evaluation and subjective appetite responses will be assessed using a seven-point hedonic scale and a visual analogue scale (VAS), including appearance, flavor, texture, satiety, and expected intake. The collected data will be statistically analyzed to compare differences in glycemic index (GI) among cookie formulations and to evaluate the feasibility of developing low-GI cookies as blood glucose-friendly food products.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

People With Diabetes

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 20-70 years old * BMI between 18.5 and 25 kg/m² Exclusion Criteria: * History of gastrointestinal or metabolic diseases. * Fasting plasma glucose \> 100 mg/dL. * Abnormal OGTT results (2-h glucose \> 140 mg/dL or any point \> 200 mg/dL with 50-g glucose). * Academic conflict of interest, specifically students currently enrolled in courses taught by the investigators (Associate Prof. You-Cheng Shen or Dr. Ching-Pin Lin). * Known hypersensitivity or allergy to any ingredients of the study product or potential cross-contaminants (e.g., gluten, mango, peanuts, sesame, milk, eggs, kiwi, or seeds). * Pregnant or lactating

Outcomes

Primary Outcomes

Glycemic Index (GI) Testing

Capillary blood glucose levels will be measured after consumption of the test foods to calculate the glycemic index (GI) of each cookie formulation. Blood glucose will be monitored at multiple time points following ingestion of the test product.

Time frame: 0, 15, 30, 45, 60, 90, and 120 minutes after consumption of the test food

Sensory Acceptability

Sensory evaluation will be conducted using a seven-point hedonic scale (1 = dislike extremely, 7 = like extremely). Participants will rate the selected optimal cookie formulation in terms of appearance, taste, aroma, texture, and overall acceptability.

Time frame: Immediately after consumption of the test cookie

Subjective Appetite Assessment

Subjective appetite responses will be assessed using a visual analogue scale (VAS). Participants will report their perceived satiety, fullness, hunger, and expected food intake after consuming the test cookie.

Time frame: 15, 30, 45, 60, 90, and 120 minutes after consumption of the test cookie