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Screened 34 participants and only 3 participants met the inclusion criteria, the study was stopped and screening data will be analyzed for associations.
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| Name | Class |
|---|---|
| Abbott Nutrition | INDUSTRY |
| dsm-firmenich Switzerland AG | INDUSTRY |
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The purpose of this study is to determine whether specific nutrient supplementation can improve dynamic stability in older adults.
The primary objective of this study is to evaluate the effect of a single nutrient dietary supplement on dynamic stability in an older population. Dynamic stability, or walking stability, will be assessed with accelerometers while subjects are walking on a flat surface for about 60 seconds. Dynamic stability will be defined by the maximum Lyapunov exponent (maxLE), Floquet multiplier, or motor control timing, change from baseline. Postural stability will also be measured in a still and standing subject, with foot placement standardized on a force plate, and with the subject looking in the forward direction with arms by their sides. Two visual conditions will be given: eyes-open (EO) and eyes-closed (EC). Each measurement will last for 60 seconds and will be repeated twice for each condition. A three-minute rest will be provided between measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Supplement | Experimental | This experimental arm reflects administration of a softgel capsule containing a dose of (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol below the upper tolerable limit |
|
| Control | Experimental | This experimental arm reflects administration of placebo in softgel capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol | Dietary Supplement | 25 micrograms of (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol every day for 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Stability, change from baseline | Dynamic stability will be defined by the maximum Lyapunov exponent (maxLE), Floquet multiplier, or motor control timing, change from baseline. Dynamic stability, or walking stability, will be assessed with accelerometers while subjects are walking on a flat surface for about 60 seconds. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postural Stability, change from baseline | Postural stability will be measured in a still and standing subject, with foot placement standardized on a force plate, and with the subject looking in the forward direction with arms by their sides. Two visual conditions will be given: eyes-open (EO) and eyes-closed (EC). Each measurement will last for 60 seconds and will be repeated twice for each condition. A three minute rest will be provided between measurements. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Measures, change from baseline | Participants will be asked to provide blood for analysis of nutrient levels. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glencroft Senior Living: Retirement Community in Arizona | Glendale | Arizona | 85302 | United States |
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| Label | URL |
|---|---|
| Dietary Nutrient Information | View source |
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The data will be shared with Abbott Nutrition and DSM Nutritional Products, Inc.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2021 | Jan 17, 2021 | Prot_SAP_000.pdf |
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| Control | Other | Placebo in Softgel form |
|
| 6 months |
| Gait Speed, change from baseline | Participants will perform two bouts of walking at their usual pace along a flat surface. The two walks will be aggregated and average gait speed derived. Stride length, base width, sway will also be measured. | 6 months |
| Handgrip Strength, change from baseline | Isometric handgrip strength will be measured with a hand dynamometer embedded with a strain gauge. | 6 months |
| Timed get-up and go (TUG), change from baseline | Participants will be asked to stand from a seated position, walk 3 meters at their usual pace, turn around, walk back to the chair, and sit down. | 6 months |