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It is a 12-week study. The participants will follow three different diets, and during each diet period, and the participants will wear our device, and blood samples will be collected.
The investigators will conduct a randomized, controlled crossover intervention study. The investigators will enroll 54 participants, aged >18 years, BMI >25 kg/m2 with metabolic syndrome. During the first phase, all participants will consume their habitual diet for 2 weeks to establish baseline. Then participants will be randomized to either a Mediterranean diet (MED), high-fat/low carb diet (HF/LC), or low-fat diet (LF) for 14 days with 2 weeks washout between the different diets. The wearable system will monitor basal levels and the changes for glucose, cholesterol, TG, and NO through sweat analysis and HR, HRV, and PWV for carotid arterial stiffness during each diet intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet 1 (one of the three kinds of diets) | Active Comparator | participants will be randomized to diet 1 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered. |
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| Diet 2 (one of the two remaining kinds of diets, excluding Diet 1) | Active Comparator | participants will be randomized to diet 2 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered. |
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| Diet 3 (the final remaining diet) | Active Comparator | participants will be randomized to diet 3 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered. |
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| Habitual diet as a baseline | Experimental | All participants will consume their habitual diet for 2 weeks to establish baseline. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF) | Dietary Supplement | Participants will be randomized to either Mediterranean diet (MED), high-fat/low carb diet (HF/LC), or low-fat diet (LF). |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of glucose | The concentration of glucose (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism | From enrollment to the end of measurement at 12 weeks |
| Concentration of cholesterol | The concentration of cholesterol (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism. | From enrollment to the end of measurement at 12 weeks |
| Concentration of triacylglycerol (TG) | The concentration of triacylglycerol (TG) (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism. | From enrollment to the end of measurement at 12 weeks] |
| Concentration of Nitric oxide (NO) | The concentration of Nitric oxide (NO) (ppm) will be measured during each visit, across the different diets, to evaluate changes in metabolism. | From enrollment to the end of measurement at 12 weeks |
| Measurement of heart rate (HR) | The heart rate (HR) (bpm) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness indirectly. | From enrollment to the end of measurement at 12 weeks |
| Measurement of heart rate variability (HRV) | The heart rate variability (HRV) (ms) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness indirectly. | From enrollment to the end of measurement at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | The Body mass index (BMI) (kg/m2) will be measured during each visit, across the different diets, to evaluate changes of body fat. | From enrollment to the end of measurement at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tzung Hsiai, M.D., Ph.D. | Contact | 310-478-3711 | thsiai@mednet.ucla.edu | |
| Peng Zhao, M.D., Ph.D. | Contact | 310-279-0248 | pengzhao@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tzung Hsiai, M.D., Ph.D. | VAGLAHS and UCLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Va Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
The results of a research study may be published in the medical literature or presented at scientific medical or educational meetings, but the Veteran participant's name or identity will not be revealed, and their records will remain confidential unless disclosure of your identity is required by law.
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| The integrated sweat sensor and vascular sensor (wearable) | Device | The integrated sweat sensor and vascular sensor will be worn of each diet period. |
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| continuous glucose monitor (CGM) | Device | A continuous glucose monitor (CGM) will be placed on the patients during each diet period. |
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| Measurement of pulse wave velocity (PWV) | The pulse wave velocity (PWV) (m/s) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness. | From enrollment to the end of measurement at 12 weeks |
| Body weight | The body weight (BW) (kg) will be measured during each visit, across the different diets, to evaluate changes of BMI. | From enrollment to the end of measurement at 12 weeks |
| Height | The height (m) will be measured during each visit, across the different diets, to evaluate changes in BMI. | From enrollment to the end of measurement at 12 weeks |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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