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Completed

NCT Number: NCT04199949

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

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.

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Key information

Conditions

FMD

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The University of Nottingham

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Smoking
  • 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)

Treatment and study plan

Inactivity

Behavioral

On days 1 and 6 of each main trial, the participants will be asked to attend the laboratory after an overnight fast of at least 8 to 12h to undergo brachial and popliteal arteries FMD measurements (30 min apart) using duplex-Doppler ultrasound, followed by assessment of the hand grip strength of their non-dominant hand using a hand dynamometer.

Primary outcomes

  1. 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

  2. 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

  1. Hand grip strength

    Time frame: 3 minutes

    The hand grip strength will be measured using a hand dynamometer. Three maximum hand grips separated by one minute rest at the end of each visit.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2019
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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