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

NCT ID: NCT03018496

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-12-31

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.

Conditions

Insulin Resistance; Age Problems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Older Men

Healthy male adults aged 18-35 Subjects will receive both HMB and placebo on separate visits in a crossover fashion

Group Type: EXPERIMENTAL

Beta-Hydroxy-Beta-Methylbutyrate

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Younger Men

Healthy male adults aged 65-85 Subjects will receive both HMB and placebo on separate visits in a crossover fashion

Group Type: EXPERIMENTAL

Beta-Hydroxy-Beta-Methylbutyrate

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Interventions

Beta-Hydroxy-Beta-Methylbutyrate

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Other Intervention Names

HMB

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Of Nottingham

Derby, , United Kingdom

Countries

United Kingdom

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.

Reference Type: BACKGROUND

PMID: 10480510 (View on PubMed)

Other Identifiers

A12092016- ammendment 1

Identifier Type: -

Identifier Source: org_study_id