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Clinical Trials/NCT04199949
NCT04199949
Completed
Not Applicable

Effects of Five Days of Physical Inactivity on Endothelial Function in Healthy Humans

University of Nottingham1 site in 1 country8 target enrollmentNovember 1, 2018
ConditionsFMD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
FMD
Sponsor
University of Nottingham
Enrollment
8
Locations
1
Primary Endpoint
Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Physical inactivity is a significant predictor of major non-communicable diseases such as type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some types of cancer, and has been proposed to be the 4th leading cause of death worldwide. The investigators aim is to assess the vascular (endothelial) function before and after a 5-day period of reduced activity of upper and lower limbs via an arm sling and daily step counts reduction, respectively, in healthy participants. Twelve young (ages of 18 - 35 years), healthy, males and females, recreationally active with a body mass index between 18 and 27 kg/m2 will be recruited. The participants will then randomly undergo two 5-day interventions: (A) 5 consecutive days of habitual daily levels of physical activity and matched food intake (Control trial). (B) 5 consecutive days of reduced step count by 80% compared to the Control trial combined with their non-dominant arm placed in a sling and a reduction in food (energy) intake (~20%) to match the reduction in energy expenditure induced by inactivity (Inactivity trial). On days 1 and 6 of each experimental trial, the endothelial function of the brachial and popliteal arteries, and hand grip strength will be measured.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
March 1, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Moira Taylor

Dr Moira A Taylor

University of Nottingham

Eligibility Criteria

Inclusion Criteria

  • Non-smoking
  • Age (18-35 years old)
  • Body mass index (BMI) of 18-27 kg/m2
  • Recreationally active
  • Ability to give informed consent

Exclusion Criteria

  • Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure
  • Clinically significant abnormalities on screening including ECG abnormalities
  • Taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
  • Well-trained individuals
  • On an energy-restricted diet or seeking to lose weight
  • High alcohol consumption (\<3-4 units/day)

Outcomes

Primary Outcomes

Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery

Time Frame: Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm

The FMD of the brachial artery will be measured using an ultrasound collected at baseline and continuously for 80 seconds post-arm occlusion for 5 minutes

Change from baseline of flow-mediated vasodilatation (FMD) of the popliteal artery

Time Frame: Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm

The FMD of the popliteal artery will be measured using an ultrasound collected at baseline and continuously for 80 seconds post-arm occlusion for 5 minutes

Secondary Outcomes

  • Hand grip strength(3 minutes)

Study Sites (1)

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