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

Not Applicable

Completed

• Conditions: Metabolic Health; Energy Expenditure
• Interventions: Behavioral: Sitting; Behavioral: Self-selected maximal intensity of neuromuscular electrical stimulation; Behavioral: Standing

• Registration Number: NCT04389736
• Lead Sponsor: National Taiwan Normal University

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

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 Timeline

• Study Start: 2018-11-27
• Primary Completion: 2019-01-09
• Study Completion: 2019-01-20
• Study First Submitted: 2020-03-27
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-11
• Last Update Submitted: 2020-05-11
• Study First Posted: 2020-05-15
• Last Update Posted: 2020-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SIT	Sitting	Sitting
NMES	Self-selected maximal intensity of neuromuscular electrical stimulation	Self-selected maximal intensity of neuromuscular electrical stimulation
STAND	Standing	Standing

Primary Outcome Measures

Name	Time	Method
Changes in total energy expenditure during OGTT test.	120 minutes	Changes in total energy expenditure during OGTT test.

Secondary Outcome Measures

Name	Time	Method
Changes in blood glycaemic responses during OGTT test.	120 minutes	Changes in blood glycaemic responses during OGTT test.
Changes in blood insulinaemic responses during OGTT test.	120 minutes	Changes in blood insulinaemic responses during OGTT test.
Changes in gut hormones (GLP-1, GIP & PYY etc.) responses during OGTT test.	120 minutes	Changes in gut hormones (GLP-1, GIP \& PYY etc.) responses during OGTT test.
Changes in total lipid oxidation during OGTT test.	120 minutes	Changes in total lipid oxidation during OGTT test.
Changes in blood pressure during OGTT test.	120 minutes	Changes in blood pressure during OGTT test.
Changes in heart rate during OGTT test.	120 minutes	Changes in heart rate during OGTT test.
Changes in total carbohydrate during OGTT test.	120 minutes	Changes in total carbohydrate during OGTT test.

Trial Locations

Locations (1)

National Taiwan Normal University; 🇨🇳 Taipei, Taiwan