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

NCT07504016 | Completed DMC

• 1 other identifier: CS2-25089
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

People With Diabetes

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Study Arms (2)

Group A

EXPERIMENTAL

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.

Other: Group A

B group

EXPERIMENTAL

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.

Other: Group B

Interventions

Group A OTHER

Test sequence: D-glucose solution → Almond Brown Rice Cookie → Almond White Rice Cookie → Oatmeal Cookie

Group A

Group B OTHER

Test sequence: D-glucose solution → Almond White Rice Cookie → Almond Brown Rice Cookie → Oatmeal Cookie

B group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• BMI between 18.5 and 25 kg/m²

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: October 24, 2025
• Primary Completion: December 4, 2025
• Study Completion: December 4, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-02

Locations

TW (1)