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

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 Overview

• Status: Completed
• Conditions: People With Diabetes
• Intervention / Treatment: Other: Group A; Other: Group B

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Group A; Test sequence: D-glucose solution → Almond Brown Rice Cookie → Almond White Rice Cookie → Oatmeal Cookie
Experimental: B group; 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; Test sequence: D-glucose solution → Almond White Rice Cookie → Almond Brown Rice Cookie → Oatmeal Cookie

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2025
• Primary Completion (Actual): December 4, 2025
• Study Completion (Actual): December 4, 2025

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CS2-25089

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No