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

NCT07504016 — Not applicable, Completed, 12 participants, Chung Shan Medical University

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Registry	NCT07504016
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, prevention
Enrollment	12 (Actual)
Sponsor	Chung Shan Medical University (Other)
Conditions	People With Diabetes
Interventions	Group A, Group B (Other)
Dates	start 2025-10-24, primary completion 2025-12-04, completion 2025-12-04, first posted 2026-03-31, last updated 2026-03-31
Locations	1 site in Taiwan

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group A	Experimental	Other: Group A	Five participants randomized to Group A will receive four test samples in sequence: D-glucose solution, Almond Brown Rice Cookie, Almond White Rice Cookie and Oatmeal Cookie.
B group	Experimental	Other: Group B	Five participants randomized to B group will receive four test samples in sequence: D-glucose solution, Almond White Rice Cookie, Almond Brown Rice Cookie, and Oatmeal Cookie.

Group A (Other): Test sequence: D-glucose solution → Almond Brown Rice Cookie → Almond White Rice Cookie → Oatmeal Cookie
Group B (Other): Test sequence: D-glucose solution → Almond White Rice Cookie → Almond Brown Rice Cookie → Oatmeal Cookie

+Outcome measures

Primary outcomes

Glycemic Index (GI) Testing [0, 15, 30, 45, 60, 90, and 120 minutes after consumption of the test food]: 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.
Sensory Acceptability [Immediately after consumption of the test cookie]: 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.
Subjective Appetite Assessment [15, 30, 45, 60, 90, and 120 minutes after consumption of the test cookie]: 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.

+Eligibility

Sex: All, ages: 20 Years to 80 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Chung Shan Medical University	Taichung	Taiwan