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

Primary Purpose

Insulin Resistance, Age Problems

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Beta-Hydroxy-Beta-Methylbutyrate
Placebo
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • University Of Nottingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Older Men

Younger Men

Arm Description

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

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

Outcomes

Primary Outcome Measures

Matsuda Index of insulin sensitivity
Assessed from arterialised venous blood samples
Cederholm index of insulin sensitivity
Assessed from arterialised venous blood samples

Secondary Outcome Measures

Area-Under-Curve Glucose Concentration
Assessed from arterialised venous blood samples
Area-Under-Curve Insulin Concentration
Assessed from arterialised venous blood samples
Femoral Artery Blood flow
Assessed using duplex ultrasonography of the superficial femoral artery of the right leg

Full Information

First Posted
January 10, 2017
Last Updated
March 8, 2019
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT03018496
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Age Problems

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Older Men
Arm Type
Experimental
Arm Description
Healthy male adults aged 18-35 Subjects will receive both HMB and placebo on separate visits in a crossover fashion
Arm Title
Younger Men
Arm Type
Experimental
Arm Description
Healthy male adults aged 65-85 Subjects will receive both HMB and placebo on separate visits in a crossover fashion
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta-Hydroxy-Beta-Methylbutyrate
Other Intervention Name(s)
HMB
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Matsuda Index of insulin sensitivity
Description
Assessed from arterialised venous blood samples
Time Frame
180 minutes after a 75g oral glucose load
Title
Cederholm index of insulin sensitivity
Description
Assessed from arterialised venous blood samples
Time Frame
180 minutes after a 75g oral glucose load
Secondary Outcome Measure Information:
Title
Area-Under-Curve Glucose Concentration
Description
Assessed from arterialised venous blood samples
Time Frame
180 minutes after a 75g oral glucose load
Title
Area-Under-Curve Insulin Concentration
Description
Assessed from arterialised venous blood samples
Time Frame
180 minutes after a 75g oral glucose load
Title
Femoral Artery Blood flow
Description
Assessed using duplex ultrasonography of the superficial femoral artery of the right leg
Time Frame
15 minutes, 60 minutes and 120 minutes after a 75g oral glucose load

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University Of Nottingham
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10480510
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.
Results Reference
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Investigating the Effects of Beta-Hydroxy-Beta-Methylbutyrate on Glucose Handling in Older and Younger Men.

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