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

NCT ID: NCT06422429

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-12-01

Brief 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.

Detailed 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.

Conditions

Metabolism and Nutrition Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control group

traditional Youtiao

Group Type: PLACEBO_COMPARATOR

Traditional deep-fried Youtiao

Intervention Type: DRUG

45g 4 times a week for 4 months

Intervention group

Personalised and innovative Youtiao

Group Type: EXPERIMENTAL

PI Youtiao

Intervention Type: DRUG

45g 4 times a week for 4 months

Interventions

Traditional deep-fried Youtiao

45g 4 times a week for 4 months

Intervention Type: DRUG

PI Youtiao

45g 4 times a week for 4 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yu Zhang

OTHER

Sponsor Role: lead

Responsible Party

Yu Zhang

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Yu Zhang, PHD

Role: CONTACT

yzhang@zju.edu.cn

86-0571-88982211

Other Identifiers

RCT_PI Youtiao

Identifier Type: -

Identifier Source: org_study_id