AgingNCT02806765
Effect of Dietary Supplementation on Dynamic Stability
A study testing (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 in people with Aging, run by Arizona State University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether specific nutrient supplementation can improve dynamic stability in older adults. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- (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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
- Subject is male or female and is ≥ 65 and ≤ 85 years of age.
- Subject has Body Mass Index (BMI) ≥ 20 but ≤ 32 kg/m2.
- Subject is ambulatory and able to walk ≥ 25 meters without the use of an assistive device.
- Subject has a serum 25-hydroxyvitamin D level ≥ 7.5 but ≤ 22.5 ng/ml (18.75 to 56.25 nmol/L) at screening.
- Subject agrees to apply sunscreen (≥ SPF 30) on any exposed skin, when expecting an increase in exposure to sunlight (e.g. a planned holiday of more than eight days, a beach holiday or a holiday in the southern hemisphere, for the duration of the study).
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- Subject agrees not to use tanning beds for the duration of the study.
- Subject agrees to refrain from starting any new exercise program, or weight loss program, for the duration of the study.
- Subject is able to follow the protocol.
Who cannot join
- Subject states they regularly consume supplemental vitamin D in the amount greater than the age-specific Institute Of Medicine daily recommended dietary allowance (600 IU or 15 µg for a subject ≥ 65 to ≤ 70 years of age; 800 IU or 20 µg for a subject > 70 years of age). Supplemental vitamin D includes standalone vitamin D supplements, vitamin D supplements with calcium, multi-vitamins, any medications containing vitamin D, and purposefully seeking sunlight when outdoors.
- Subject states they have received vitamin D3 by injection within the last 3 months.
- Subject is missing, or has had an amputation of, a limb.
- For a subject who reports > 2 falls within the last year, or one fall within the last year with injury, study physician and study PI must approve participation in the study.
- Subject states they have an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
- Subject states they have sarcoidosis, lymphoma, primary hyperparathyroidism, or any other disease that may enhance serum calcium concentration, as determined by the study physician.
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- Subject states they have had kidney stones within the last 3 years.
- Subject states they have abnormal indices of calcium metabolism including hypercalcemia.
- Subject states they have a granulomatous disease such as sarcoidosis, active chronic tuberculosis, and Wegener's granulomatosis.
- Subject states they have been diagnosed with renal failure, renal insufficiency, or chronic kidney disease, or has received hemodialysis.
- Subject states they have an active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix.
- Subject states they have liver failure (decompensated chronic liver disease).
- Subject has a stated history of a significant cardiovascular event (e.g., myocardial infarction, heart failure, or stroke) ≤ 3 months prior to screening visit.
- Subject states they are currently diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study dietary supplement consumption or compliance with study protocol procedures in the opinion of the principal investigator or study physician.
- Subject reports having undergone major surgery, less than 6 weeks prior to enrollment in the study, or subject has planned inpatient surgery requiring 2 or more days of hospitalization during the entire study.
- Subject states they have undergone hip replacement surgery within the last year.
- Subject states they are currently being prescribed (by primary care physician or other health professional) medication that in the opinion of the study physician will have an effect on serum 25-hydroxyvitamin D levels (e.g., certain anticonvulsants, phenobarbital, carbamazepine, phenytoin).
- Subject states they have been undergoing treatment within the last 2 years for epilepsy, and the treatment has an effect on serum 25-hydroxyvitamin D.
- Subject states they have been prescribed within the last 2 years bisphosphonates or parathyroid hormone.
- Subject states they cannot refrain from anabolic hormones or growth hormone, starting at screening and over the entire course of the study.
- Subject reports alcohol intake as average of 3 or more servings per day (a serving defined as 4 oz wine, 12 oz beer, 1 oz spirits).
- Subject states they have an allergy or intolerance to any ingredient in the study product.
- Subject is deemed unsuitable for study based upon study physician assessment.
- Subject is taking part in another clinical trial.
- The use of fat absorption inhibiting products (e.g., prescription orlistat (Xenical), over the counter orlistat (Alli)) during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glencroft Senior Living: Retirement Community in Arizona
Glendale, Arizona, 85302
About this study
Official title: Effects of a Single Nutrient Supplementation on Dynamic Stability in Community Dwelling Older Adults
The purpose of this study is to determine whether specific nutrient supplementation can improve dynamic stability in older adults.
Read the detailed description
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.
- Conditions
- Aging
- Being tested
- (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, Control
- Keywords
- Dynamic Stability, Postural Stability, Gait Speed, Hand Grip Strength, Timed Get-up and Go, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(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-olDietary 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
ControlOther
Placebo in Softgel form
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: (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 |
| Control | Experimental | This experimental arm reflects administration of placebo in softgel capsule Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 6 months
Handgrip Strength, change from baseline
Isometric handgrip strength will be measured with a hand dynamometer embedded with a strain gauge.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017
Why it stopped: Screened 34 participants and only 3 participants met the inclusion criteria, the study was stopped and screening data will be analyzed for associations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition, dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Thurmon E. Lockhart, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806765
- Sponsor's protocol ID
- ANAM1308
- Status last verified
- Jan 2023
- First submitted
- 7 Jun 2016
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data will be shared with Abbott Nutrition and DSM Nutritional Products, Inc.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Nutrient Supplementation on Dynamic Stability in Community Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT02806765
- Acronym / sponsor ID
- ANAM1308
- Conditions
- Aging
- Keywords
- Dynamic Stability, Postural Stability, Gait Speed, Hand Grip Strength, Timed Get-up and Go, Older Adults
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Screened 34 participants and only 3 participants met the inclusion criteria, the study was stopped and screening data will be analyzed for associations.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Abbott Nutrition, dsm-firmenich Switzerland AG
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether specific nutrient supplementation can improve dynamic stability in older adults.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Experimental | Dietary Supplement: (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-olThis 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 | Other: ControlThis experimental arm reflects administration of placebo in softgel capsule |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
- Subject is male or female and is ≥ 65 and ≤ 85 years of age.
- Subject has Body Mass Index (BMI) ≥ 20 but ≤ 32 kg/m2.
- Subject is ambulatory and able to walk ≥ 25 meters without the use of an assistive device.
- Subject has a serum 25-hydroxyvitamin D level ≥ 7.5 but ≤ 22.5 ng/ml (18.75 to 56.25 nmol/L) at screening.
Key exclusion criteria (25 listed)
- Subject states they regularly consume supplemental vitamin D in the amount greater than the age-specific Institute Of Medicine daily recommended dietary allowance (600 IU or 15 µg for a subject ≥ 65 to ≤ 70 years of age; 800 IU or 20 µg for a subject > 70 years of age). Supplemental vitamin D includes standalone vitamin D supplements, vitamin D supplements with calcium, multi-vitamins, any medications containing vitamin D, and purposefully seeking sunlight when outdoors.
- Subject states they have received vitamin D3 by injection within the last 3 months.
- Subject is missing, or has had an amputation of, a limb.
- For a subject who reports > 2 falls within the last year, or one fall within the last year with injury, study physician and study PI must approve participation in the study.
- Subject states they have an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (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-ol25 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 | Dietary supplement | Dietary Supplement |
| ControlPlacebo in Softgel form | Other | Control |
Primary outcome
Dynamic Stability, change from baseline
Time frame: 6 months
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.
4 secondary outcomes
Postural Stability, change from baseline
Time frame: 6 months
Gait Speed, change from baseline
Time frame: 6 months
Handgrip Strength, change from baseline
Time frame: 6 months
Timed get-up and go (TUG), change from baseline
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Dietary Nutrient InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data will be shared with Abbott Nutrition and DSM Nutritional Products, Inc.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (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 in people with Aging, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Stability, change from baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.