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

NCT ID: NCT04199949

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-03-01

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.

Conditions

FMD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

5 consecutive days of normal daily levels of physical activity and matched food intake

Group Type: NO_INTERVENTION

No interventions assigned to this group

Inactivity

5 consecutive days of reduced step count by 80% compared to the Control trial, whilst placing the non-dominant arm in a sling, and reduced food intake (\~ 20%) to match the reduction in energy expenditure induced by inactivity

Group Type: EXPERIMENTAL

Inactivity

Intervention Type: 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.

Interventions

Inactivity

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Moira Taylor

Dr Moira A Taylor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Nottingham

Nottingham, Nottinghamshire, United Kingdom

Countries

United Kingdom

Other Identifiers

A90355

Identifier Type: -

Identifier Source: org_study_id