Effect of Dietary Supplementation on Dynamic Stability

NCT02806765 | Withdrawn

• 1 other identifier: ANAM1308
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether specific nutrient supplementation can improve dynamic stability in older adults.

Conditions

Aging

Keywords

Dynamic Stability; Postural Stability; Gait Speed; Hand Grip Strength; Timed Get-up and Go; Older Adults

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Postural Stability, change from baseline

  6 months

• Gait Speed, change from baseline

  6 months

• Handgrip Strength, change from baseline

  6 months

• Timed get-up and go (TUG), change from baseline

  6 months

Other Outcomes (1)

• Blood Measures, change from baseline

  6 months

Study Arms (2)

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

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

Other: Control

Interventions

(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

Dietary Supplement

Control OTHER

Placebo in Softgel form

Control

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Arizona State University: lead
• Abbott Nutrition: collaborator
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

Glencroft Senior Living: Retirement Community in Arizona

Glendale, Arizona, 85302, United States

Location

Related Links

• Dietary Nutrient Information

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 21, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)