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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolism and Nutrition Disorder
• Intervention / Treatment: Drug: Traditional deep-fried Youtiao; Drug: PI Youtiao

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yu Zhang, PHD; Phone Number: 86-0571-88982211; Email: yzhang@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; traditional Youtiao	Drug: Traditional deep-fried Youtiao; 45g 4 times a week for 4 months
Experimental: Intervention group; Personalised and innovative Youtiao	Drug: PI Youtiao; 45g 4 times a week for 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	The investigators will measure HbA1c in blood samples before and after treatment.	6 months
Change in blood glucose from baseline	The investigators will measure fasting plasma glucose levels in blood samples before and after treatment.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yu Zhang

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: RCT_PI Youtiao

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No