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

U

University of Nottingham

Status

Completed

Conditions

Insulin Resistance
Age Problems

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03018496
A12092016- ammendment 1

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Male

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 2 patient groups

Older Men
Experimental group
Description:
Healthy male adults aged 18-35 Subjects will receive both HMB and placebo on separate visits in a crossover fashion
Treatment:
Other: Placebo
Dietary Supplement: Beta-Hydroxy-Beta-Methylbutyrate
Younger Men
Experimental group
Description:
Healthy male adults aged 65-85 Subjects will receive both HMB and placebo on separate visits in a crossover fashion
Treatment:
Other: Placebo
Dietary Supplement: Beta-Hydroxy-Beta-Methylbutyrate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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