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OpenTrials
Completed

NCT Number: NCT07504016

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.

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Key information

Conditions

People With Diabetes

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Glycemic Index (GI) Testing

    Time frame: 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.

  2. Sensory Acceptability

    Time frame: 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.

  3. Subjective Appetite Assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.