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

Energy Expenditure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04389736
• Other study ID #: EP 17/18 230
• Status: Completed
• Phase: N/A
• Start date: November 27, 2018
• Est. completion date: January 20, 2019

Study information

• Verified date: May 2020
• Source: National Taiwan Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 20, 2019
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Energy Expenditure
• Metabolic Health

Intervention

Behavioral:
• Sitting
Participants sat in a chair with back, arms and legs supported.
• Standing
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
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan Normal University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan Normal University	University of Bath

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in total energy expenditure during OGTT test.	Changes in total energy expenditure during OGTT test.	120 minutes
Secondary	Changes in blood glycaemic responses during OGTT test.	Changes in blood glycaemic responses during OGTT test.	120 minutes
Secondary	Changes in blood insulinaemic responses during OGTT test.	Changes in blood insulinaemic responses during OGTT test.	120 minutes
Secondary	Changes in blood pressure during OGTT test.	Changes in blood pressure during OGTT test.	120 minutes
Secondary	Changes in heart rate during OGTT test.	Changes in heart rate during OGTT test.	120 minutes
Secondary	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.	120 minutes
Secondary	Changes in total carbohydrate during OGTT test.	Changes in total carbohydrate during OGTT test.	120 minutes
Secondary	Changes in total lipid oxidation during OGTT test.	Changes in total lipid oxidation during OGTT test.	120 minutes