The Effects of the Oral Nutritional Supplement With β-hydroxy-β-methylbutyrate in Lean Body Mass Among Taiwan Elderly
Condition: Frail Elderly Syndrome; Nutrition Disorders in Old Age; Muscle Loss
MeSH terms: Nutrition Disorders
Study type: Interventional

Summary: 
      Primary objective:

      To evaluate the effects of additional oral nutritional supplement containing
      β-hydroxy-β-methylbutyrate (HMB) on thigh muscle mass in elderly subjects with pre-frail
      status

      Secondary objectives:

        1. To evaluate the effects of additional oral nutritional supplement containing
           β-hydroxy-β-methylbutyrate on physical performance, nutrition status, and quality of
           life in elderly subjects with pre-frail status

        2. To determine the safety profile of additional oral nutritional supplement containing
           β-hydroxy-β-methylbutyrate in elderly subjects with pre-frail status
    

Detailed description: 
      This is a controlled, open-label, parallel-group, randomized, investigator initiated study to
      evaluate the effectiveness of oral nutritional supplement containing
      β-hydroxy-β-methylbutyrate (Ensure® Plus Advance) on thigh muscle mass and physical
      performance in elderly subjects with pre-frail status. The study is planned to enroll a total
      of 70 elderly subjects with pre-frail status defined by Fried's criteria with modified cutoff
      values as suggested by Asian Working Group for Sarcopenia (AWGS) for Asian population. The
      subject to be enrolled will meet the phenotypic definition of pre-frail for one or two of
      five phenotypic criteria: weakness as measured by grip strength, slow walking speed, low
      level of physical activity, self-reported exhaustion, and unintentional weight loss.

      After obtaining informed consent and the confirmation of eligibility, subjects will be
      randomized into the HMB or control group in a 1:1 ratio. All enrolled subjects will be under
      standard care, which is mainly dietary consultation for healthy aging by dietitians to assure
      sufficient dietary protein intake in all subjects. Subjects assigned to the HMB group will
      consume 2 bottles of Ensure® Plus Advance per day for 12 weeks additionally, while subjects
      assigned to the control group will not receive any placebo or active control.

      In this study, subjects will be requested for a total of 4 visits at the clinical site,
      including screening visit, Visit 1 for randomization, Visit 2 at Week 6, and Visit 3 at Week
      12 (end of study/EOS). The telephone visit will be scheduled at Week 3 and Week 9 to
      follow-up with subjects.

      Thigh muscle mass of all subjects will be evaluated by MRI. The physical performance of
      subjects will be determined by short physical performance battery (SPPB) and handgrip
      strength. The nutrition status of subjects will be measured by MNA® -SF and nutrition
      biomarkers, including serum albumin, pre-albumin, 25-hydroxy-vitamin D, vitamin B12, and
      C-reactive protein (CRP). SF-36v2™ Health Survey will be used to evaluate the quality of life
      of subjects. The safety profile of Ensure® Plus Advance will be determined by monitoring the
      adverse event (AE/SAE) during the study period. Blood samples of each subject will be
      collected at Visits 1, 2 and 3 for analysis of nutrition biomarkers. There will be a total of
      approximately 30 mL of blood to be collected from each subject during the study period.
    

Intervention name(s): Ensure® Plus Advance
Intervention type(s): Dietary Supplement
Intervention description(s): Previous studies suggest that protein supplementation is an effective dietary strategy to decrease frailty by positively influence the weight loss or sarcopenia in elderly.
Lean body mass includes all body tissue except fat and is well recognized to be associated with an increased risk of morbidity and mortality. Oral nutrition supplements have been shown to increase food intake and body weight, but not lean body mass. In previous studies, β-hydroxy-β-methylbutyrate, which is leucine metabolite, has been shown to enhance protein synthesis and decrease protein degradation leading to increase lean body mass. It showed that β-hydroxy-β-methylbutyrate supplement with exercise increased lean body mass in health elderly population and improved the physical performance in elderly women.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care