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The objective of this project is to provide evidence that L-Citrulline (CIT) supplementation can improve vascular function in the fasted and acute hyperglycemia conditions in middle-aged and older women with metabolic syndrome.
Using a double-blind, randomized, placebo-controlled, and parallel design, middle-aged and older women with metabolic syndrome will be randomized into receiving either CIT supplementation (10g/day) or placebo (Microcrystalline Cellulose) for 4 weeks.
The first visit will be approximately 1hr and 30 minutes. The 2nd and 3rd visits will each be approximately 2hrs and 30 minutes, separated by 4 weeks in between each visit. During visits 2 and 3, vascular measurements will be assessed in the fasted state and 30, 60, and 90 minutes after acute glucose ingestion (75g).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-citrulline | Experimental | L-citrulline: 10 grams/day |
|
| Placebo | Experimental | Microcrystalline Cellulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Citrulline supplementation | Dietary Supplement | 4 weeks of L-Citrulline supplementation (10 grams/day). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Macrovascular Endothelial function in the fasted condition | Endothelial function will be measured via brachial artery flow mediated dilation (ultrasonography) during reactive hyperemia at baseline and after 4 weeks of supplementation. | 4 weeks |
| Microvascular endothelial function in the fasted condition | Endothelial function will be measured using forearm muscle oxygenation (near-infrared spectroscopy) will assessed during reactive hyperemia at baseline and after 4 weeks of supplementation. | 4 weeks |
| Microvascular digital endothelial function in the fasted condition | Endothelial function will be measured using peripheral (finger) arterial tonometry (EndoPAT device) during reactive hyperemia at baseline and after 4 weeks of supplementation. | 4 weeks |
| Macrovascular Endothelial function during acute hyperglycemia | Endothelial function will be measured via brachial artery flow mediated dilation (ultrasonography) during reactive hyperemia at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation. | 4 weeks |
| Microvascular forearm endothelial function during acute hyperglycemia | Endothelial function will be measured using forearm muscle oxygenation (near-infrared spectroscopy) during reactive hyperemia at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation. | 4 weeks |
| Central and peripheral arterial stiffness in the fasted condition | Arterial stiffness will be measured using central (carotid-femoral) and peripheral (femoral-ankle) PWV at baseline and after 4 weeks of supplementation. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum glucose and insulin levels. | Serum glucose and insulin levels will be tested at baseline and after 4 weeks of supplementation. | 4 weeks |
| Serum arginine levels | Serum L-Arginine levels will be tested at baseline and after 4 weeks of supplementation. |
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Inclusion Criteria:
Must present at least 3 of the following 5 cardiometabolic risk factors
The following are also inclusion criteria's:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arturo Figueroa | Texas Tech University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TTU Kinesiology and Sport Management Building | Lubbock | Texas | 79409 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37049398 | Background | Figueroa A, Maharaj A, Kang Y, Dillon KN, Martinez MA, Morita M, Nogimura D, Fischer SM. Combined Citrulline and Glutathione Supplementation Improves Endothelial Function and Blood Pressure Reactivity in Postmenopausal Women. Nutrients. 2023 Mar 23;15(7):1557. doi: 10.3390/nu15071557. | |
| 34974502 | Background |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Parallel Assignment Double (Participant, Investigator) Randomized, double-blind, placebo-controlled, parallel study design
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| Placebo | Dietary Supplement | 4 weeks of microcrystalline Cellulose supplementation. |
|
| 4 weeks |
| Central arterial stiffness during acute hyperglycemia | Arterial stiffness will be measured using central (carotid-femoral) PWV at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation. | 4 weeks |
| Blood pressure in the fasted condition | Brachial and aortic blood pressures will be assessed using an automated sphygmomanometry arm cuff (SphygmoCor XCEL). Beat-to-beat blood pressure will be measured using an automated photoplethysmography finger cuff (Fineometer). Blood pressure will be measured at baseline and after 4 weeks of supplementation. | 4 weeks |
| Blood pressure during acute hyperglycemia | Brachial and aortic blood pressures (systolic and diastolic) will be assessed using an automated sphygmomanometry arm cuff (SphygmoCor XCEL). Beat-to-beat blood pressure will be measured using an automated photoplethysmography finger cuff (Fineometer). Blood pressure will be measured after an oral glucose ingestion at 30, 60, and 90 minutes at baseline and after 4 weeks of supplementation. | 4 weeks |
| Total peripheral resistance in the fasted condition. | Total peripheral resistance will be measured using an automated photoplethysmography finger cuff (Finometer) at baseline and after 4 weeks of supplementation. | 4 weeks |
| Total peripheral resistance during acute hyperglycemia | Total peripheral resistance will be measured using an automated photoplethysmography finger cuff (Finometer) at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation. | 4 weeks |
| Stroke volume in the fasted condition | Stroke volume will be measured using an automated photoplethysmography finger cuff (Finometer) at baseline and after 4 weeks of supplementation. | 4 weeks |
| Stroke volume during acute hyperglycemia | Stroke volume will be measured using an automated photoplethysmography finger cuff (Finometer) at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation. | 4 weeks |
| 24-hour ambulatory blood pressure monitoring | An ambulatory blood pressure cuff, measuring blood pressure for 24-hours will be obtained on two separate days at baseline and after 4 weeks of supplementation. | 4 weeks |
| 4 weeks |
| Serum arginase levels | Serum arginase levels will be tested at baseline and after 4 weeks of supplementation. | 4 weeks |
| Serum Nitric Oxide levels | Serum nitric oxide levels will be tested at baseline and after 4 weeks of supplementation. | 4 weeks |
| Serum Endothelin-1 levels | Serum endothelin-1 levels will be tested at baseline and after 4 weeks of supplementation. | 4 weeks |
| Maharaj A, Fischer SM, Dillon KN, Kang Y, Martinez MA, Figueroa A. Acute Citrulline Blunts Aortic Systolic Pressure during Exercise and Sympathoactivation in Hypertensive Postmenopausal Women. Med Sci Sports Exerc. 2022 May 1;54(5):761-768. doi: 10.1249/MSS.0000000000002848. Epub 2022 Jan 3. |
| 30412905 | Background | McDonald JD, Mah E, Chitchumroonchokchai C, Dey P, Labyk AN, Villamena FA, Volek JS, Bruno RS. Dairy milk proteins attenuate hyperglycemia-induced impairments in vascular endothelial function in adults with prediabetes by limiting increases in glycemia and oxidative stress that reduce nitric oxide bioavailability. J Nutr Biochem. 2019 Jan;63:165-176. doi: 10.1016/j.jnutbio.2018.09.018. Epub 2018 Sep 25. |
| 25636814 | Background | Figueroa A, Alvarez-Alvarado S, Ormsbee MJ, Madzima TA, Campbell JC, Wong A. Impact of L-citrulline supplementation and whole-body vibration training on arterial stiffness and leg muscle function in obese postmenopausal women with high blood pressure. Exp Gerontol. 2015 Mar;63:35-40. doi: 10.1016/j.exger.2015.01.046. Epub 2015 Jan 28. |
| 36297080 | Result | Maharaj A, Fischer SM, Dillon KN, Kang Y, Martinez MA, Figueroa A. Effects of L-Citrulline Supplementation on Endothelial Function and Blood Pressure in Hypertensive Postmenopausal Women. Nutrients. 2022 Oct 20;14(20):4396. doi: 10.3390/nu14204396. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |