NCT04389736

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

March 27, 2020

Last Update Submit

May 11, 2020

Conditions

Energy ExpenditureMetabolic Health

Keywords

Neuromuscular electrical stimulationInsulin resistanceStandingGlucose control

Outcome Measures

Primary Outcomes (1)

  • Changes in total energy expenditure during OGTT test.

    Changes in total energy expenditure during OGTT test.

    120 minutes

Secondary Outcomes (7)

  • Changes in blood glycaemic responses during OGTT test.

    120 minutes

  • Changes in blood insulinaemic responses during OGTT test.

    120 minutes

  • Changes in blood pressure during OGTT test.

    120 minutes

  • Changes in heart rate during OGTT test.

    120 minutes

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

    120 minutes

  • +2 more secondary outcomes

Study Arms (3)

SIT

EXPERIMENTAL

Sitting

Behavioral: Sitting

STAND

EXPERIMENTAL

Standing

Behavioral: Standing

NMES

EXPERIMENTAL

Self-selected maximal intensity of neuromuscular electrical stimulation

Behavioral: Self-selected maximal intensity of neuromuscular electrical stimulation

Interventions

SittingBEHAVIORAL

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

SIT
StandingBEHAVIORAL

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.

STAND
Self-selected maximal intensity of neuromuscular electrical stimulationBEHAVIORAL

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.

NMES

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and women
  • Aged between 18 to 65 years
  • Weight stable for more than 3 months (no change in weight +/- 3%)
  • Non-smoker

You may not qualify if:

  • Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
  • Taking medications that may influence lipid or carbohydrate metabolism or immune system function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 34403626DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Sitting PositionStanding Position

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2020

First Posted

May 15, 2020

Study Start

November 27, 2018

Primary Completion

January 9, 2019

Study Completion

January 20, 2019

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

TW(1)