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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018496
• Other study ID #: A12092016- ammendment 1
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Age Problems
• Insulin Resistance

Intervention

Dietary Supplement:
• Beta-Hydroxy-Beta-Methylbutyrate

Other:
• Placebo

Locations

Country	Name	City	State
United Kingdom	University Of Nottingham	Derby

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Matsuda Index of insulin sensitivity	Assessed from arterialised venous blood samples	180 minutes after a 75g oral glucose load
Primary	Cederholm index of insulin sensitivity	Assessed from arterialised venous blood samples	180 minutes after a 75g oral glucose load
Secondary	Area-Under-Curve Glucose Concentration	Assessed from arterialised venous blood samples	180 minutes after a 75g oral glucose load
Secondary	Area-Under-Curve Insulin Concentration	Assessed from arterialised venous blood samples	180 minutes after a 75g oral glucose load
Secondary	Femoral Artery Blood flow	Assessed using duplex ultrasonography of the superficial femoral artery of the right leg	15 minutes, 60 minutes and 120 minutes after a 75g oral glucose load