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

May 11, 2020 updated by: Yung-Chih Chen, National Taiwan Normal University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan Normal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SIT
Sitting
Behavioral: Sitting
Participants sat in a chair with back, arms and legs supported.
Experimental: STAND
Standing
Behavioral: 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.
Experimental: NMES
Self-selected maximal intensity of neuromuscular electrical stimulation
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in total energy expenditure during OGTT test.
Time Frame: 120 minutes
Changes in total energy expenditure during OGTT test.
120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in blood glycaemic responses during OGTT test.
Time Frame: 120 minutes
Changes in blood glycaemic responses during OGTT test.
120 minutes
Changes in blood insulinaemic responses during OGTT test.
Time Frame: 120 minutes
Changes in blood insulinaemic responses during OGTT test.
120 minutes
Changes in blood pressure during OGTT test.
Time Frame: 120 minutes
Changes in blood pressure during OGTT test.
120 minutes
Changes in heart rate during OGTT test.
Time Frame: 120 minutes
Changes in heart rate during OGTT test.
120 minutes
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.
120 minutes
Changes in total carbohydrate during OGTT test.
Time Frame: 120 minutes
Changes in total carbohydrate during OGTT test.
120 minutes
Changes in total lipid oxidation during OGTT test.
Time Frame: 120 minutes
Changes in total lipid oxidation during OGTT test.
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan Normal University

Collaborators

University of Bath

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2018

Primary Completion (Actual)

January 9, 2019

Study Completion (Actual)

January 20, 2019

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 11, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EP 17/18 230

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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