Precision Medicine and Physical Function

Официальное название

A Precision Nutrition Approach to Enhancing Physical Function in Older Adults: A Pilot, Feasibility Study

Обзор

The investigators aim to conduct a 12-week, single-arm, pre/post-intervention of b-hydroxy-methylbutyrate in persons aged 65 to 85 years to assess feasibility and acceptability of the intervention and study procedures, secondary outcomes of physical function and changes in multi-omics patterns, and exploratory outcomes that will allow the team to describe physical function phenotype. The investigators' primary outcomes are the: feasibility of the study procedures (including safety), feasibility of the intervention delivery, and acceptability of study procedures and measures. Secondary outcomes include: Objective and subjective physical function measures that predict disability including the 30-second sit-to-stand, knee strength, isokinetic strength, grip strength, gait speed, 400-m walk test, Pittsburgh Fatiguability, PROMIS global health-10, social support, anthropometry, National Institutes of Health (NIH) Cognitive toolbox, Automated Self-Administered 24-hour Dietary Assessment (ASA-24), Community Healthy Activities Model Programs (CHAMPS), Ultrasound Imaging, Magnetic Resonance Imaging (MRI), Changes in untargeted metabolomic profile data based on qualitative or semiquantitative analysis of the most probable detectable metabolites in laboratory samples , Discover potential metabolites that explain changes in physical function using a discovery science, precision medicine approach (discovery science approach that is exploratory)

Вмешательства

• Пищевая добавка Beta-hydroxymethyl butyrate supplement
  Beta-hydroxymethyl butyrate (750 mg) - Vitamin D3 (200 IU) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate with 200 IU of vitamin D3 per capsule. Frequency is 2 capsules twice daily (morning, evening)
• Пищевая добавка Vitamin D supplement
  Beta-hydroxymethyl butyrate (750 mg) - Vitamin D3 (200 IU) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate with 200 IU of vitamin D3 per capsule. Frequency is 2 capsules twice daily (morning, evening)
• Пищевая добавка Matching Beta-hydroxymethyl butyrate supplement without Vitamin D
  Beta-hydroxymethyl butyrate (750 mg) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate per capsule. Frequency is 2 capsules twice daily (morning, evening)

Первичные конечные точки

• Percentage of Participants Enrolled [Срок оценки: at 12-weeks]
• Number of Participants Screened [Срок оценки: Through the end of the study period (~1 year) based on data collected on each participant at the conclusion of the study intervention (12-weeks).]
• Percentage of participants consented [Срок оценки: Through the end of the study period (~1 year) based on data collected on each participant at the conclusion of the study intervention (12-weeks).]
• Percent attendance [Срок оценки: Through the end of the study period (~1 year) based on data collected on each participant at the conclusion of the study intervention (12-weeks).]
• Percent of Interviews completed [Срок оценки: Through the end of the study period (~1 year) based on data collected on each participant at the conclusion of the study intervention (12-weeks).]
• Percentage of study measures collected [Срок оценки: 12 weeks after baseline visit]
• Percent of participants conducted MRI measure [Срок оценки: 12 weeks after baseline visit]
• Percent of participants conducted ultrasound measure [Срок оценки: 12 weeks after baseline visit]
• Acceptability of study intervention [Срок оценки: 12 weeks after baseline visit]
• Percent of Participants Rating the Intervention as Acceptable [Срок оценки: 12 weeks after baseline visit]

Вторичные конечные точки (12)

• Change in weight from baseline [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• Change in waist circumference from baseline [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• Change in hip circumference from baseline [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• Change in arm circumference from baseline [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• Change in calf circumference from baseline [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• Change in Language using the Picture Vocabulary Test [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• Change in Executive function using the Dimensional Change Card Sort Test [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• Change in Episodic memory using the Picture sequence memory test [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• Change in Working memory using the List Sorting Test [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• Change in Processing speed using the Pattern Comparison Test [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• Change in caloric intake [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• Changes in total cholesterol blood levels from baseline [Срок оценки: At baseline and 12 weeks]

Критерии участия

Критерии включения

• English-speaking older adults aged 65 to 85 years (of all genders and sexes, race or ethnicity)
• A University of North Carolina at Chapel Hill (UNC) Geriatrics Medicine clinic patient;
• Chronic medical conditions -these are based on the 21 Medicare multiple chronic conditions (e.g., alcohol abuse, arthritis (osteoarthritis, rheumatoid), asthma, atrial fibrillation, autism spectrum disorders, cancer (breast, colorectal, lung, prostate), chronic kidney disease, chronic obstructive pulmonary disease, depression, diabetes, drug/substance abuse, heart failure, hepatitis, HIV/AIDS, hyperlipidemia, hypertension, ischemic heart disease, osteoporosis, schizophrenia/other psychotic disorders, stroke);

Критерии исключения

• Age <65 years and >85 years old
• A medical diagnosis of dementia
• Those without a negative subjective weakness screener (<1)
• Individuals with life-threatening or untreated psychiatric diagnosis that would interfere with study participation and require significant modification to meet their needs such as untreated major depressive disorder, substance abuse, suicidal ideation or untreated severe mental illness (schizophrenia, bipolar disorder)
• Life-threatening illness including those receiving palliative care or hospice services
• Individuals unwilling/unable to provide consent
• Inability to complete the protocol procedures
• Elective surgery in the next four months
• Medications - antiobesity (weight loss agents) medications that lead to weight loss
• Hospitalization for heart failure in past 6 months, advanced non-skin cancer (Stage III or IV) on treatment; Advanced liver failure; Chronic renal insufficiency on hemodialysis; advanced Chronic obstructive pulmonary disease (COPD) that would prevent engagement

\*\*\*Vitamin D >80 ng/dL:

• At baseline, the investigators will check Vit D levels - recognize that processing is highly dependent on the McLendon lab and may take up to 7+ days to come back.
• Concurrently, the investigators will consider continuing consent, enrollment, study procedures.
• Provide at Visit 2 the beta-hydroxymethyl butyrate/Vitamin D supplement
• Once the results have been received and reviewed - if the levels exceed 80 ng/dL, then the participant will be informed.
• At that point, the investigators will either exclude the participant or, if available, see whether the company is willing to provide formulations of just beta-hydroxymethyl butyrate (HMB)and provide this to the participant
• These guidelines account for the fact that Vit D is not recommended by American Geriatrics Society to check routinely, and that levels <80 (or even 120 ng/mL) rarely lead to toxicity.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of North Carolina at Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT05877846 · 23-0141

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗