Study on the Regulatory Effects of Personalized Innovative Youtiao Intervention on Nutritional Health

Metabolism and Nutrition Disorder Clinical Trial

Official title:

Study on the Regulatory Effects of Personalized Innovative Youtiao Intervention on Nutritional Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422429
• Other study ID #: RCT_PI Youtiao
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2025
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: Zhejiang University
• Contact: Yu Zhang, PHD
• Phone: 86-0571-88982211
• Email: yzhang[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to investigate the effects of personalized innovative fritters on the nutritional health of overweight and obese individuals aged 40 to 70 years. The main questions it aims to answer are: - How does consuming personalized innovative fritters affect the nutritional health of overweight and obese individuals? - What is the mechanism underlying the impact of personalized innovative oil bars on nutritional health? Participants will be randomly assigned to one of two groups: a trial group consuming personalized innovative fritters and a control group consuming traditional fritters with equal energy content. Over the course of 6 months, participants will undergo two phases of intervention separated by a two-month washout period. During the intervention, participants will be assessed comprehensively for sensory ratings and nutritional health status through biological indicators, physical examinations, and other relevant measures. Researchers will compare the trial group to the control group to determine if personalized innovative fritters lead to improvements in nutritional health compared to traditional fritters.

Description:

Participants entered the trial with a 1-week equilibration period during which baked and fried foods were prohibited. The test group will consume personalised innovative Youtiao and the control group will uniformly consume traditional Youtiao of equal energy, 45 g 4 times per week for 8 weeks, during which time we will periodically measure biological indicators and collect biological samples to gain insight into the effects of the personalised innovative Youtiao on the participants. After completion of the 8-week intervention, a washout phase is entered. During this phase, participants will no longer ingest the Youtiao to see how they trend after stopping the intervention. Participants then enter the second phase of the trial, where the intervention process described above is continued with appropriate consumption adjustments based on the initial results of the first phase of the intervention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age between 40-70 years old (women need to be menopausal);
• BMI>24 kg/m2;
• Consumption of fritters more than once a week.

Exclusion Criteria:

• history of diabetes mellitus, cardiovascular disease, dyslipidaemia, renal disease, -
• liver disease or cancer;
• surgical treatment within 3 months;
• allergy/intolerance to the study food or any of its ingredients;
• breastfeeding or pregnancy;
• >10% weight loss in the past 6 months;
• smoking or alcohol abuse;
• participation in another clinical study within the past 6 months

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders

Intervention

Drug:
• Traditional deep-fried Youtiao
45g 4 times a week for 4 months
• PI Youtiao
45g 4 times a week for 4 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yu Zhang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	The investigators will measure HbA1c in blood samples before and after treatment.	6 months
Primary	Change in blood glucose from baseline	The investigators will measure fasting plasma glucose levels in blood samples before and after treatment.	6 months
Secondary	Change in blood lipids from baseline	The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.	6 months