## Protocol Section
### Identification Module
**NCT ID:** NCT06422429

**Brief Title:** Study on the Regulatory Effects of Personalized Innovative Youtiao Intervention on Nutritional Health

**Official Title:** Study on the Regulatory Effects of Personalized Innovative Youtiao Intervention on Nutritional Health

#### Organization Study ID Info
**ID:** RCT_PI Youtiao
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang University
### Status Module
#### Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-03-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yu Zhang

#### Responsible Party

**Investigator Affiliation:** Zhejiang University

**Investigator Full Name:** Yu Zhang

**Investigator Title:** professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Metabolism and Nutrition Disorder

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** traditional Youtiao

**Intervention Names:**

- Drug: Traditional deep-fried Youtiao

**Label:** Control group

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Personalised and innovative Youtiao

**Intervention Names:**

- Drug: PI Youtiao

**Label:** Intervention group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control group

**Description:** 45g 4 times a week for 4 months

**Name:** Traditional deep-fried Youtiao

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Intervention group

**Description:** 45g 4 times a week for 4 months

**Name:** PI Youtiao

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The investigators will measure HbA1c in blood samples before and after treatment.

**Measure:** Change in HbA1c

**Time Frame:** 6 months

**Description:** The investigators will measure fasting plasma glucose levels in blood samples before and after treatment.

**Measure:** Change in blood glucose from baseline

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.

**Measure:** Change in blood lipids from baseline

**Time Frame:** 6 months

### Eligibility Module

**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

**Maximum Age:** 70 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yzhang@zju.edu.cn

**Name:** Yu Zhang, PHD

**Phone:** 86-0571-88982211

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12684

- Name: Nutrition Disorders

- Relevance: HIGH

- As Found: Nutrition Disorders

### Condition Browse Module - Meshes

- ID: D000009748

- Term: Nutrition Disorders

### Misc Info Module

- Version Holder: 2024-05-31
