Energy ExpenditureNCT04389736
Effects of NMES on Energy Expenditure, Glycaemia and Hormonal Responses to Glucose Ingestion
A study testing Sitting, Standing and Self-selected maximal intensity of neuromuscular electrical stimulation in people with Energy Expenditure and Metabolic Health, run by National Taiwan Normal University at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Expenditure, Metabolic Health
- What is being tested?
- Sitting, Standing and Self-selected maximal intensity of neuromuscular electrical stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Nov 2018to 20 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women
- Aged between 18 to 65 years
- Weight stable for more than 3 months (no change in weight +/- 3%)
- Non-smoker
Who cannot join
- Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
- Taking medications that may influence lipid or carbohydrate metabolism or immune system function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Energy Expenditure, Metabolic Health
- Being tested
- Sitting, Standing, Self-selected maximal intensity of neuromuscular electrical stimulation
- Keywords
- Neuromuscular electrical stimulation, Insulin resistance, Standing, Glucose control
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SittingBehavioural
Participants sat in a chair with back, arms and legs supported.
StandingBehavioural
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 stimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SIT | Experimental | Sitting Receives: Behavioral: Sitting |
| STAND | Experimental | Standing Receives: Behavioral: Standing |
| NMES | Experimental | Self-selected maximal intensity of neuromuscular electrical stimulation Receives: Behavioral: Self-selected maximal intensity of neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total energy expenditure during OGTT test.
Changes in total energy expenditure during OGTT test.
Measured: 120 minutes
Secondary outcomes (7)
Changes in blood glycaemic responses during OGTT test.
Changes in blood glycaemic responses during OGTT test.
Measured: 120 minutes
Changes in blood insulinaemic responses during OGTT test.
Changes in blood insulinaemic responses during OGTT test.
Measured: 120 minutes
Changes in blood pressure during OGTT test.
Changes in blood pressure during OGTT test.
Measured: 120 minutes
Changes in heart rate during OGTT test.
Changes in heart rate during OGTT test.
Measured: 120 minutes
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.
Measured: 120 minutes
Changes in total carbohydrate during OGTT test.
Changes in total carbohydrate during OGTT test.
Measured: 120 minutes
Changes in total lipid oxidation during OGTT test.
Changes in total lipid oxidation during OGTT test.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start27 Nov 2018
- Primary completion9 Jan 2019
- Study completion20 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Energy ExpenditureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bath
- Responsible party
- Principal investigator, Yung-Chih Chen, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389736
- Sponsor's protocol ID
- EP 17/18 230
- Status last verified
- May 2020
- First submitted
- 27 Mar 2020
- Last updated
- 15 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen Y.-C., Davies R.G., Hengist A., Carroll H.A., Perkin O.J., Betts J.A., Thompson D.. Effects of neuromuscular electrical stimulation on energy expenditure and postprandial metabolism in healthy men. Appl Physiol Nutr Metab. 2022 Jan;47(1):27-33. doi: 10.1139/apnm-2021-0361. Epub 2021 Aug 17.
PubMed 34403626
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-selected Maiximal Intensity of Neuromuscular Electrical Stimulation (NMES) on Energy Expenditure, Glycaemia and Hormonal Responses on Healthy Individuals
- ClinicalTrials.gov ID
- NCT04389736
- Acronym / sponsor ID
- EP 17/18 230
- Conditions
- Energy Expenditure, Metabolic Health
- Keywords
- Neuromuscular electrical stimulation, Insulin resistance, Standing, Glucose control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Collaborators
- University of Bath
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SIT | Experimental | Behavioral: SittingSitting |
| STAND | Experimental | Behavioral: StandingStanding |
| NMES | Experimental | Behavioral: Self-selected maximal intensity of neuromuscular electrical stimulationSelf-selected maximal intensity of neuromuscular electrical stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy men and women
- Aged between 18 to 65 years
- Weight stable for more than 3 months (no change in weight +/- 3%)
- Non-smoker
Key exclusion criteria (2 listed)
- Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
- Taking medications that may influence lipid or carbohydrate metabolism or immune system function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SittingParticipants sat in a chair with back, arms and legs supported. | Behavioural | SIT |
| StandingParticipants 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. | Behavioural | STAND |
| Self-selected maximal intensity of neuromuscular electrical stimulationSmall 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. | Behavioural | NMES |
Primary outcome
Changes in total energy expenditure during OGTT test.
Time frame: 120 minutes
Changes in total energy expenditure during OGTT test.
7 secondary outcomes
Changes in blood glycaemic responses during OGTT test.
Time frame: 120 minutes
Changes in blood insulinaemic responses during OGTT test.
Time frame: 120 minutes
Changes in blood pressure during OGTT test.
Time frame: 120 minutes
Changes in heart rate during OGTT test.
Time frame: 120 minutes
Changes in gut hormones (GLP-1, GIP & PYY etc.) responses during OGTT test.
Time frame: 120 minutes
Changes in total carbohydrate during OGTT test.
Time frame: 120 minutes
Changes in total lipid oxidation during OGTT test.
Time frame: 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Derived from this study: PubMed 34403626Chen Y.-C., Davies R.G., Hengist A., Carroll H.A., Perkin O.J., Betts J.A., Thompson D.. Effects of neuromuscular electrical stimulation on energy expenditure and postprandial metabolism in healthy men. Appl Physiol Nutr Metab. 2022 Jan;47(1):27-33. doi: 10.1139/apnm-2021-0361. Epub 2021 Aug 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitting, Standing and Self-selected maximal intensity of neuromuscular electrical stimulation in people with Energy Expenditure and Metabolic Health, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in total energy expenditure during OGTT test. (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04389736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.