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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07504016
Enrollment
12
Registered
2026-03-31
Start date
2025-10-24
Completion date
2025-12-04
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

People With Diabetes

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.

Interventions

OTHERGroup A

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

OTHERGroup B

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

Sponsors

Chung Shan Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Glycemic Index (GI) Testing0, 15, 30, 45, 60, 90, and 120 minutes after consumption of the test foodCapillary 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 AcceptabilityImmediately after consumption of the test cookieSensory 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 Assessment15, 30, 45, 60, 90, and 120 minutes after consumption of the test cookieSubjective 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026