Insulin ResistanceNCT03018496
Investigating the Effects of Beta-Hydroxy-Beta-Methylbutyrate on Glucose Handling in Older and Younger Men.
A study testing Beta-Hydroxy-Beta-Methylbutyrate in people with Insulin Resistance and Age Problems, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Age Problems
- What is being tested?
- Beta-Hydroxy-Beta-Methylbutyrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Aged 18-35 or 65-85
- Male
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Beta-Hydroxy-Beta-Methylbutyrate, Placebo
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-Hydroxy-Beta-MethylbutyrateDietary supplement
Also called HMB
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Older Men | Experimental | Healthy male adults aged 18-35 Subjects will receive both HMB and placebo on separate visits in a crossover fashion Receives: Dietary Supplement: Beta-Hydroxy-Beta-Methylbutyrate; Other: Placebo |
| Younger Men | Experimental | Healthy male adults aged 65-85 Subjects will receive both HMB and placebo on separate visits in a crossover fashion Receives: Dietary Supplement: Beta-Hydroxy-Beta-Methylbutyrate; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matsuda Index of insulin sensitivity
Assessed from arterialised venous blood samples
Measured: 180 minutes after a 75g oral glucose load
Cederholm index of insulin sensitivity
Assessed from arterialised venous blood samples
Measured: 180 minutes after a 75g oral glucose load
Secondary outcomes (3)
Area-Under-Curve Glucose Concentration
Assessed from arterialised venous blood samples
Measured: 180 minutes after a 75g oral glucose load
Area-Under-Curve Insulin Concentration
Assessed from arterialised venous blood samples
Measured: 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
Measured: 15 minutes, 60 minutes and 120 minutes after a 75g oral glucose load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018496
- Sponsor's protocol ID
- A12092016- ammendment 1
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 10480510
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Beta-Hydroxy-Beta-Methylbutyrate on Glucose Handling in Older and Younger Men.
- ClinicalTrials.gov ID
- NCT03018496
- Acronym / sponsor ID
- A12092016- ammendment 1
- Conditions
- Insulin Resistance, Age Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older Men | Experimental | Dietary Supplement: Beta-Hydroxy-Beta-Methylbutyrate, Other: PlaceboHealthy male adults aged 18-35 Subjects will receive both HMB and placebo on separate visits in a crossover fashion |
| Younger Men | Experimental | Dietary Supplement: Beta-Hydroxy-Beta-Methylbutyrate, Other: PlaceboHealthy male adults aged 65-85 Subjects will receive both HMB and placebo on separate visits in a crossover fashion |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Aged 18-35 or 65-85
- Male
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-Hydroxy-Beta-MethylbutyrateAlso: HMB | Dietary supplement | Older Men, Younger Men |
| Placebo | Other | Older Men, Younger Men |
Primary outcome
Matsuda Index of insulin sensitivity
Time frame: 180 minutes after a 75g oral glucose load
Assessed from arterialised venous blood samples
Cederholm index of insulin sensitivity
Time frame: 180 minutes after a 75g oral glucose load
Assessed from arterialised venous blood samples
3 secondary outcomes
Area-Under-Curve Glucose Concentration
Time frame: 180 minutes after a 75g oral glucose load
Area-Under-Curve Insulin Concentration
Time frame: 180 minutes after a 75g oral glucose load
Femoral Artery Blood flow
Time frame: 15 minutes, 60 minutes and 120 minutes after a 75g oral glucose load
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Background: PubMed 10480510Matsuda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-Hydroxy-Beta-Methylbutyrate in people with Insulin Resistance and Age Problems, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matsuda Index of insulin sensitivity (time frame: 180 minutes after a 75g oral glucose load). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03018496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.