Investigating the Effects of Beta-Hydroxy-Beta-Methylbutyrate on Glucose Handling in Older and Younger Men.

Overview

This study intends to examine the effect of a commercially available nutritional supplement, Beta-hydroxy-beta-methylbutyrate(HMB) on whole-body responses to a sugar load.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2018

Detailed Description

One change associated with human aging is a reduction in "fitness", both in terms of how far or quickly a person can run/cycle/swim and also in how well their blood vessels work. Additionally a person's metabolic fitness decreases; this is how well the body copes with nutrition and is why, for example, older people have a higher risk of diseases like type 2 diabetes. Previous studies have shown that as people become less fit, they are at increased risk of suffering a complication whilst undergoing surgery. It has also been shown that measuring how fit someone is, is better at predicting the risk of a surgical complication than purely using a person's age alone. Lots of research has shown that exercise can potentially reverse some of the age-related declines in fitness, however most has used long sessions of continuous exercise over a long period of time. High-intensity interval training (HIT), whereby people cycle on an exercise bike very hard for a minute, followed by a short rest, repeated over the course of 15 minutes can rapidly improve a person's fitness. However not everyone will be able to, or indeed want to participate in exercise this strenuous; therefore this research seeks to explore whether other options, such as dietary supplements can improve aspects of fitness This study intends to examine the effect of giving a dietary supplement on the way a person's body handles the glucose (from carbohydrates/ sugars) in a meal. Previous work has shown that taking a beta-hydroxy beta-methyl butyrate (HMB) supplement may improve may improve a patient's response to glucose, however the evidence is not clear. HMB is a commercially available nutritional supplement providing a compound that the body produces each time protein is consumed, and is most commonly used by bodybuilders to help gain muscle.

Interventions

  • Dietary Supplement: Beta-Hydroxy-Beta-Methylbutyrate
  • Other: Placebo

Arms, Groups and Cohorts

  • Experimental: Older Men
    • Healthy male adults aged 18-35 Subjects will receive both HMB and placebo on separate visits in a crossover fashion
  • Experimental: Younger Men
    • Healthy male adults aged 65-85 Subjects will receive both HMB and placebo on separate visits in a crossover fashion

Clinical Trial Outcome Measures

Primary Measures

  • Matsuda Index of insulin sensitivity
    • Time Frame: 180 minutes after a 75g oral glucose load
    • Assessed from arterialised venous blood samples
  • Cederholm index of insulin sensitivity
    • Time Frame: 180 minutes after a 75g oral glucose load
    • Assessed from arterialised venous blood samples

Secondary Measures

  • Area-Under-Curve Glucose Concentration
    • Time Frame: 180 minutes after a 75g oral glucose load
    • Assessed from arterialised venous blood samples
  • Area-Under-Curve Insulin Concentration
    • Time Frame: 180 minutes after a 75g oral glucose load
    • Assessed from arterialised venous blood samples
  • Femoral Artery Blood flow
    • Time Frame: 15 minutes, 60 minutes and 120 minutes after a 75g oral glucose load
    • Assessed using duplex ultrasonography of the superficial femoral artery of the right leg

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy volunteers – Aged 18-35 or 65-85 – Male Exclusion Criteria:

  • Current participation in a formal exercise regime – A BMI < 18 or > 32 kg·m2 – Active cardiovascular disease: o uncontrolled hypertension (BP > 160/100), angina, heart failure (class III/IV), Significant arrhythmia, right to left cardiac shunt, recent cardiac event – Taking beta-adrenergic blocking agents, – Cerebrovascular disease: o previous stroke, aneurysm (large vessel or intracranial), epilepsy – Respiratory disease including: o pulmonary hypertension, significant COPD, uncontrolled asthma, – Metabolic disease: o hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, type 1 or 2 diabetes – Active inflammatory bowel or renal disease – Malignancy – Clotting dysfunction – Significant musculoskeletal or neurological disorders – Family history of early (<55y) death from cardiovascular disease

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Nottingham
  • Provider of Information About this Clinical Study
    • Sponsor

References

Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.

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