Skip to main content
OpenTrials
Completed

NCT Number: NCT04389736

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan Normal University

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Sitting

Behavioral

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

Standing

Behavioral

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.

Self-selected maximal intensity of neuromuscular electrical stimulation

Behavioral

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.

Primary outcomes

  1. Changes in total energy expenditure during OGTT test.

    Time frame: 120 minutes

    Changes in total energy expenditure during OGTT test.

Secondary outcomes

  1. Changes in blood glycaemic responses during OGTT test.

    Time frame: 120 minutes

    Changes in blood glycaemic responses during OGTT test.

  2. Changes in blood insulinaemic responses during OGTT test.

    Time frame: 120 minutes

    Changes in blood insulinaemic responses during OGTT test.

  3. Changes in blood pressure during OGTT test.

    Time frame: 120 minutes

    Changes in blood pressure during OGTT test.

  4. Changes in heart rate during OGTT test.

    Time frame: 120 minutes

    Changes in heart rate during OGTT test.

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

    Time frame: 120 minutes

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

  6. Changes in total carbohydrate during OGTT test.

    Time frame: 120 minutes

    Changes in total carbohydrate during OGTT test.

  7. Changes in total lipid oxidation during OGTT test.

    Time frame: 120 minutes

    Changes in total lipid oxidation during OGTT test.

Sponsors and collaborators

Lead sponsor

National Taiwan Normal University

Other

Collaborators

  • University of Bath

Registry information

Official study title

Effects of Self-selected Maiximal Intensity of Neuromuscular Electrical Stimulation (NMES) on Energy Expenditure, Glycaemia and Hormonal Responses on Healthy Individuals

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 15, 2020
Registry last updated
May 15, 2020

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.

Published trials that share one or more normalized conditions with this study.