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

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 Overview

• Status: Completed
• Conditions: Insulin Resistance; Age Problems
• Intervention / Treatment: Other: Placebo; Dietary supplement: Beta-Hydroxy-Beta-Methylbutyrate

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derby, United Kingdom, DE22 3NE
    • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Older Men; Healthy male adults aged 18-35 Subjects will receive both HMB and placebo on separate visits in a crossover fashion	Other: Placebo; Dietary supplement: Beta-Hydroxy-Beta-Methylbutyrate; Other Names: HMB
Experimental: Younger Men; Healthy male adults aged 65-85 Subjects will receive both HMB and placebo on separate visits in a crossover fashion	Other: Placebo; Dietary supplement: Beta-Hydroxy-Beta-Methylbutyrate; Other Names: HMB

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area-Under-Curve Glucose Concentration	Assessed from arterialised venous blood samples	180 minutes after a 75g oral glucose load
Area-Under-Curve Insulin Concentration	Assessed from arterialised venous blood samples	180 minutes after a 75g oral glucose load
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

Collaborators and Investigators

• Sponsor: University of Nottingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 12, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: A12092016- ammendment 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No