Study on the Regulatory Effects of Personalized Innovative Youtiao Intervention on Nutritional Health
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Change in HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40-70 years old (women need to be menopausal);
- •BMI>24 kg/m2;
- •Consumption of fritters more than once a week.
排除标准
- •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
研究组 & 干预措施
Control group
traditional Youtiao
干预措施: Traditional deep-fried Youtiao (Drug)
Intervention group
Personalised and innovative Youtiao
干预措施: PI Youtiao (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: 6 months
The investigators will measure HbA1c in blood samples before and after treatment.
Change in blood glucose from baseline
时间窗: 6 months
The investigators will measure fasting plasma glucose levels in blood samples before and after treatment.
次要结局
- Change in blood lipids from baseline(6 months)
研究者
Yu Zhang
professor
Zhejiang University