Clinical trial NCT04389736: Effects of NMES on Energy Expenditure, Glycaemia and Hormonal Responses to Glucose Ingestion
Official title: Effects of Self-selected Maiximal Intensity of Neuromuscular Electrical Stimulation (NMES) on Energy Expenditure, Glycaemia and Hormonal Responses on Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Expenditure
Metabolic Health
Keywords: Neuromuscular electrical stimulation
Insulin resistance
Standing
Glucose control
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
Collaborators: name: University of Bath
First posted: 2020-05-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate whether self-selected neuromuscular stimulation (NMES) affects energy expenditure, glycaemia and hormonal responses in healthy men and women

Detailed description: Participants were asked to perform 3 trials \[sitting (SIT), standing (STAND) and sitting with neuromuscular electrical stimulation (NMES) to the lower limbs in randomised counter-balanced study design. Trials were separated by at least 48 h and were completed within 14 days. In all trials, participants were required to remain relaxed and motionless. SIT: participants sat in a chair with back, arms and legs supported. STAND: participants were asked to stand with arms supported and feet spaced approximately 15 cm apart. If needed, adjustment of standing posture was allowed during the standing trial to prevent orthostatic hypotension. NMES: prior to the NMES trial, participants underwent preliminary testing to ensure that stimulation was comfortable. Before the NMES, a small area of the body hair was shaved and skin was cleaned with an alcohol wipe and electrodes were stuck to the surface of the skin. Small electrodes placed (5\*5 cm) on the lower limb of both legs (gastrocnemius, rectus femoris, vastus medialis). The two devices (EM 80, Beurer UK Ltd, Golborne, UK) were set up with the frequency of 20 Hz along with stimulation period of 1 second on and 1 second off throughout a 2 h oral glucose tolerance test (OGTT). The instruction for NMES intensity was that the maximal intensity participants were be able to withstand for 2 hours whilst imagining sitting at home watching TV without feeling discomfort. Prior to the OGTT, 5 min was given to identify the suitable intensity of stimulation and within the first 10 min of the OGTT participants were allowed to adjust the intensity once, after which, the intensity remained the same for the rest of OGTT. Participants were asked to sit in a chair with back, arms and legs supported during the stimulation. During trials, participants could watch TV, or read, but typing on a laptop or computer were avoided.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Aged between 18 to 65 years
* Weight stable for more than 3 months (no change in weight +/- 3%)
* Non-smoker

Exclusion Criteria:

* Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
* Taking medications that may influence lipid or carbohydrate metabolism or immune system function

Primary outcomes:
measure: Changes in total energy expenditure during OGTT test.
timeFrame: 120 minutes
Secondary outcomes:
measure: Changes in blood glycaemic responses during OGTT test.
timeFrame: 120 minutes
measure: Changes in blood insulinaemic responses during OGTT test.
timeFrame: 120 minutes
measure: Changes in blood pressure during OGTT test.
timeFrame: 120 minutes
measure: Changes in heart rate during OGTT test.
timeFrame: 120 minutes
measure: Changes in gut hormones (GLP-1, GIP & PYY etc.) responses during OGTT test.
timeFrame: 120 minutes
measure: Changes in total carbohydrate during OGTT test.
timeFrame: 120 minutes
measure: Changes in total lipid oxidation during OGTT test.
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Normal University
Study officials:
References:
citation: Chen YC, Davies RG, Hengist A, Carroll HA, Perkin OJ, Betts JA, Thompson D. Effects of neuromuscular electrical stimulation on energy expenditure and postprandial metabolism in healthy men. Appl Physiol Nutr Metab. 2021 Aug 17:1-7. doi: 10.1139/apnm-2021-0361. Online ahead of print.