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

NCT06422429 | Unknown Phase 2

• 1 other identifier: RCT_PI Youtiao
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolism and Nutrition Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in blood lipids from baseline

  6 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

traditional Youtiao

Drug: Traditional deep-fried Youtiao

Intervention group

EXPERIMENTAL

Personalised and innovative Youtiao

Drug: PI Youtiao

Interventions

Traditional deep-fried Youtiao DRUG

45g 4 times a week for 4 months

Control group

PI Youtiao DRUG

45g 4 times a week for 4 months

Intervention group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yu Zhang: lead

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Central Study Contacts

Yu Zhang, PHD

CONTACT

86-0571-88982211; yzhang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: May 21, 2024
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-01