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CompletedNCT04389736Updated May 15, 2020

Effects of NMES on Energy Expenditure, Glycaemia and Hormonal Responses to Glucose Ingestion

An interventional study of Sitting and Standing in Energy Expenditure and Metabolic Health, sponsored by National Taiwan Normal University. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-15.

Sponsored by National Taiwan Normal University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Nov 2018, registered Mar 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Energy Expenditure
  • Metabolic Health

Keywords

  • Neuromuscular electrical stimulation
  • Insulin resistance
  • Standing
  • Glucose control
03

In context

Lead sponsor

National Taiwan Normal University is the lead sponsor of 62 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    SIT

    Sitting

    Behavioral: Sitting

  • Experimental
    STAND

    Standing

    Behavioral: Standing

  • Experimental
    NMES

    Self-selected maximal intensity of neuromuscular electrical stimulation

    Behavioral: Self-selected maximal intensity of neuromuscular electrical stimulation

Interventions

  • BehavioralSitting

    Participants sat in a chair with back, arms and legs supported.

  • BehavioralStanding

    Participants were asked to stand with arms supported and feet spaced approximately 15 cm apart. If needed, adjustment of standing posture was allowed during standing trial to prevent orthostatic hypotension.

  • BehavioralSelf-selected maximal intensity of neuromuscular electrical stimulation

    Small electrodes placed (5\*5 cm) on the lower limb of both legs. 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.

06

What researchers measure

Primary outcomes

  1. Changes in total energy expenditure during OGTT test.

    Changes in total energy expenditure during OGTT test.

    Time frame: 120 minutes

Secondary outcomes

  1. Changes in blood glycaemic responses during OGTT test.

    Changes in blood glycaemic responses during OGTT test.

    Time frame: 120 minutes

  2. Changes in blood insulinaemic responses during OGTT test.

    Changes in blood insulinaemic responses during OGTT test.

    Time frame: 120 minutes

  3. Changes in blood pressure during OGTT test.

    Changes in blood pressure during OGTT test.

    Time frame: 120 minutes

  4. Changes in heart rate during OGTT test.

    Changes in heart rate during OGTT test.

    Time frame: 120 minutes

  5. Changes in gut hormones (GLP-1, GIP & PYY etc.) responses during OGTT test.

    Changes in gut hormones (GLP-1, GIP \& PYY etc.) responses during OGTT test.

    Time frame: 120 minutes

  6. Changes in total carbohydrate during OGTT test.

    Changes in total carbohydrate during OGTT test.

    Time frame: 120 minutes

  7. Changes in total lipid oxidation during OGTT test.

    Changes in total lipid oxidation during OGTT test.

    Time frame: 120 minutes

07

Study locations

1 site
  • National Taiwan Normal University
    Taipei, Taiwan
08

References and documents

Publications

  • 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. PubMed 34403626 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04389736
Lead sponsor
National Taiwan Normal University
Collaborators
University of Bath
Responsible party
Yung-Chih Chen (Principal Investigator, National Taiwan Normal University) — Principal investigator
First posted
May 15, 2020
Start date
Nov 27, 2018
Primary completion
Jan 9, 2019
Completion
Jan 20, 2019
Last update
May 15, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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