Clinical trial NCT03018496: Investigating the Effects of Beta-Hydroxy-Beta-Methylbutyrate on Glucose Handling in Older and Younger Men.
Official title: Investigating the Effects of Beta-Hydroxy-Beta-Methylbutyrate on Glucose Handling in Older and Younger Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Age Problems
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Matsuda Index of insulin sensitivity
timeFrame: 180 minutes after a 75g oral glucose load
measure: Cederholm index of insulin sensitivity
timeFrame: 180 minutes after a 75g oral glucose load
Secondary outcomes:
measure: Area-Under-Curve Glucose Concentration
timeFrame: 180 minutes after a 75g oral glucose load
measure: Area-Under-Curve Insulin Concentration
timeFrame: 180 minutes after a 75g oral glucose load
measure: Femoral Artery Blood flow
timeFrame: 15 minutes, 60 minutes and 120 minutes after a 75g oral glucose load
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University Of Nottingham
Study officials:
References:
citation: 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.