Clinical trial NCT06422429: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Metabolism and Nutrition Disorder
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
measure: Change in blood glucose from baseline
timeFrame: 6 months
Secondary outcomes:
measure: Change in blood lipids from baseline
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: