NCT03018496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 12, 2019

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

January 10, 2017

Last Update Submit

March 8, 2019

Conditions

Insulin ResistanceAge Problems

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Area-Under-Curve Glucose Concentration

    180 minutes after a 75g oral glucose load

  • Area-Under-Curve Insulin Concentration

    180 minutes after a 75g oral glucose load

  • Femoral Artery Blood flow

    15 minutes, 60 minutes and 120 minutes after a 75g oral glucose load

Study Arms (2)

Older Men

EXPERIMENTAL

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

Dietary Supplement: Beta-Hydroxy-Beta-MethylbutyrateOther: Placebo

Younger Men

EXPERIMENTAL

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

Dietary Supplement: Beta-Hydroxy-Beta-MethylbutyrateOther: Placebo

Interventions

Beta-Hydroxy-Beta-MethylbutyrateDIETARY_SUPPLEMENT
Also known as: HMB
Older MenYounger Men
PlaceboOTHER
Older MenYounger Men

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers
  • Aged 18-35 or 65-85
  • Male

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Nottingham

Derby, DE22 3NE, United Kingdom

Location

Related 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. doi: 10.2337/diacare.22.9.1462.

    PMID: 10480510BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Interventions

beta-hydroxyisovaleric acid

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 12, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 12, 2019

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)