Effect of Dietary Supplementation on Dynamic Stability

January 30, 2023 updated by: Thurmon E. Lockhart, Arizona State University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85302
        • Glencroft Senior Living: Retirement Community in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 95 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Subject is male or female and is ≥ 65 and ≤ 85 years of age.
  3. Subject has Body Mass Index (BMI) ≥ 20 but ≤ 32 kg/m2.
  4. Subject is ambulatory and able to walk ≥ 25 meters without the use of an assistive device.
  5. Subject has a serum 25-hydroxyvitamin D level ≥ 7.5 but ≤ 22.5 ng/ml (18.75 to 56.25 nmol/L) at screening.
  6. 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).
  7. Subject agrees not to use tanning beds for the duration of the study.
  8. Subject agrees to refrain from starting any new exercise program, or weight loss program, for the duration of the study.
  9. Subject is able to follow the protocol.

Exclusion Criteria:

  1. 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.
  2. Subject states they have received vitamin D3 by injection within the last 3 months.
  3. Subject is missing, or has had an amputation of, a limb.
  4. 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.
  5. 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).
  6. Subject states they have sarcoidosis, lymphoma, primary hyperparathyroidism, or any other disease that may enhance serum calcium concentration, as determined by the study physician.
  7. Subject states they have had kidney stones within the last 3 years.
  8. Subject states they have abnormal indices of calcium metabolism including hypercalcemia.
  9. Subject states they have a granulomatous disease such as sarcoidosis, active chronic tuberculosis, and Wegener's granulomatosis.
  10. Subject states they have been diagnosed with renal failure, renal insufficiency, or chronic kidney disease, or has received hemodialysis.
  11. Subject states they have an active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix.
  12. Subject states they have liver failure (decompensated chronic liver disease).
  13. Subject has a stated history of a significant cardiovascular event (e.g., myocardial infarction, heart failure, or stroke) ≤ 3 months prior to screening visit.
  14. 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.
  15. 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.
  16. Subject states they have undergone hip replacement surgery within the last year.
  17. 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).
  18. 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.
  19. Subject states they have been prescribed within the last 2 years bisphosphonates or parathyroid hormone.
  20. Subject states they cannot refrain from anabolic hormones or growth hormone, starting at screening and over the entire course of the study.
  21. 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).
  22. Subject states they have an allergy or intolerance to any ingredient in the study product.
  23. Subject is deemed unsuitable for study based upon study physician assessment.
  24. Subject is taking part in another clinical trial.
  25. The use of fat absorption inhibiting products (e.g., prescription orlistat (Xenical), over the counter orlistat (Alli)) during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dietary Supplement
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
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
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
Experimental: Control
This experimental arm reflects administration of placebo in softgel capsule
Other: Control
Placebo in Softgel form

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postural Stability, change from baseline
Time Frame: 6 months
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.
6 months
Gait Speed, change from baseline
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Measures, change from baseline
Time Frame: 6 months
Participants will be asked to provide blood for analysis of nutrient levels.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arizona State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott Nutrition
DSM Nutritional Products, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANAM1308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be shared with Abbott Nutrition and DSM Nutritional Products, Inc.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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