Skip to content

Development of "Medicinal and Edible" Herbal Meal-Replacement Biscuits Based on an Integrated Traditional Chinese and Western Medicine Intelligent Management Platform and Observation of Their Clinical Efficacy in Overweight/Obese Populations

Development of "Medicinal and Edible" Herbal Meal-Replacement Biscuits Based on an Integrated Traditional Chinese and Western Medicine Intelligent Management Platform and Observation of Their Clinical Efficacy in Overweight/Obese Populations

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002046
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-09-10
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Metabolically related diseases including overweight and obesity

Interventions

Experimental group:Patients in the experimental group consumed two herbal meal-replacement biscuits (26g each) per day as the staple food for one of their three daily meals. For that particular meal,
Control group:Patients in the control group consumed two ordinary meal-replacement biscuits (26g each, with appearance and taste similar to the main biscuits used in the experimental group) daily as t

Sponsors

Affiliated Hospital of Chengdu University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Exclusion of secondary obesity and meeting the diagnostic criteria for overweight/obesity in Western medicine; (2) Patients aged between 18 and 70 years; (3) No participation in other weight-loss-related treatments in the past 3 months; (4) Absence of impaired consciousness, stable vital signs, and generally good overall condition; (5) Voluntary participation with signed informed consent, commitment to cooperate with examinations and treatments, and no involvement in other clinical studies.

Exclusion criteria

Exclusion criteria: (1) Individuals with major diseases such as severe impairment of heart, lung, liver, or kidney function, cognitive dysfunction, aphasia, or mental disorders; (2) Individuals with severe anorexia, generally poor physical condition, inability to cooperate with examinations and treatments, or unsuitability for dietary control; (3) Individuals allergic to any ingredient in the herbal meal-replacement biscuits or ordinary meal-replacement biscuits (Note: The research team has developed two types of meal-replacement biscuits, namely herbal meal-replacement biscuits and ordinary meal-replacement biscuits. Both belong to the same product series, named "Five Elements Delight Pastry," and share similar appearance and taste. All samples have passed national food quality testing. The main components of the herbal meal-replacement biscuits include "medicinal and edible" herbs such as lotus leaf, hawthorn, mulberry leaf, bergamot, dried tangerine peel, poria cocos, coix seed, and stevia, which have passed national quality testing. Auxiliary ingredients include mulberry juice/spinach juice/dragon fruit juice/pumpkin puree/pumpkin powder/milk, cranberries, pumpkin seeds, white sesame seeds, coconut oil, corn oil, whole wheat flour, oat flour, edible salt, etc. The ordinary meal-replacement biscuits have the same composition as the herbal version, except for the omission of "medicinal and edible" herbs); (4) Patients who are pregnant or breastfeeding; (5) Individuals without a contact phone number or WeChat account, making follow-up impossible.

Design outcomes

Primary

MeasureTime frame
Weight;Body Mass Index (BMI);

Secondary

MeasureTime frame
Waist circumference;Waist-to-hip ratio;Body composition;Blood lipids;Fasting blood glucose;Fasting insulin;Blood glucose 2 hours after glucose load;Insulin level 2 hours after glucose load;Clinical symptoms;

Countries

China

Contacts

Public ContactChen Qiu

Affiliated Hospital of Chengdu University of traditional Chinese Medicine

chenqiu1969@163.com18981885702

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026