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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | traditional Youtiao |
|
| Intervention group | Experimental | Personalised and innovative Youtiao |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional deep-fried Youtiao | Drug | 45g 4 times a week for 4 months |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Zhang, PHD | Contact | 86-0571-88982211 | yzhang@zju.edu.cn |
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| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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| PI Youtiao |
| Drug |
45g 4 times a week for 4 months |
|