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CompletedNCT04172090Updated Mar 30, 2020

Effects of Physical Inactivity on Insulin Sensitivity, Appetite, Energy Balance, and Cardiovascular Responses in Humans.

An interventional study of Control and SIT+E in Sedentary Behavior, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-30.

Sponsored by University of Nottingham · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Oct 2017, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

Physical inactivity is a significant predictor of major non-communicable diseases such as type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some cancers, and has been proposed to be the 4th leading cause of death worldwide. Reduced physical activity leads to an impaired function of the hormone insulin and increased adiposity. Thus, the elimination of physical inactivity would remove between 6% and 10% of the major non-communicable diseases and increase life expectancy. The aim of the study is to investigate the effects of a short-term (2-day) period of reduced physical activity, with and without a proportional decrease in energy intake, on the action of insulin to regulate blood sugar fluctuations, appetite, and cardiovascular parameters (heart rate, cardiac output, stroke volume, blood flow, arterial blood pressure, peripheral vascular resistance) in response to food ingestion.

02

Conditions studied

  • Sedentary Behavior

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03

In context

Sedentary Behavior

367 studies on the registry are indexed under Sedentary Behavior; 165 are open to participants now.

This study's enrollment of 8 is below the median of 70 across 314 interventional studies indexed under Sedentary Behavior.

Browse Sedentary Behavior studies →

Lead sponsor

University of Nottingham is the lead sponsor of 463 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Non-smoking
  • Males and females
  • Age (18-35 years old)
  • Body mass index (BMI) of 18-27 kg/m2
  • Waist circumference \<94cm for males and \<80cm for females
  • Ability to give informed consent

Exclusion criteria

Exclusion Criteria:

  • Smoking
  • Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure
  • Clinically significant abnormalities on screening including ECG abnormalities
  • Taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
  • Well trained individuals with PAL>2.00; on an energy-restricted diet or seeking to lose weight
  • High alcohol consumption (\<3-4 units/d for men; \<2-3 units/d for women)
  • Females who are pregnant or lactating; self-reported allergy, intolerance or strong dislike of foods or drinks to be offered for the test breakfast, pasta meal or during the intervention period
  • Beck Depression Inventory score >10 and Eating Attitudes Test (EAT-26) score >20 as self-reported markers of symptoms and concerns characteristic of depression and eating disorders, respectively.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Other
    Control

    2 consecutive days of standardised daily levels of moderate physical activity (PAL=1.85 reflecting their habitual levels), and matched energy (food) intake

    Other: Control

  • Experimental
    SIT+E

    2 consecutive days of reduced physical activity induced by prolonged periods of sitting (PAL=1.4) whilst maintaining the level of food intake prescribed in the Control trial, thus creating a positive energy balance

    Other: SIT+E

  • Experimental
    SIT=E

    2 consecutive days of reduced physical activity induced by prolonged periods of sitting (PAL=1.4) whilst reducing food intake to match the reduction in energy expenditure induced by inactivity, thus maintaining energy balance

    Other: SIT=E

Interventions

  • OtherControl

    Normal physical activity and standard energy intake

  • OtherSIT+E

    Reduced physical activity and standard energy intake

  • OtherSIT=E

    Reduced physical activity and reduced energy intake

06

What researchers measure

Primary outcomes

  1. The incremental area under curve for Insulin

    The incremental area under curve for Insulin will be calculated using samples collected at 20 minute intervals between baseline and three hours

    Time frame: Over three hours from baseline

Secondary outcomes

  1. The incremental area under curve for arterialized whole blood glucose

    The incremental area under curve for arterialized whole blood glucose will be calculated using samples collected at 10 minute intervals between baseline and four hours

    Time frame: Over four hours from baseline

Other outcomes

  1. The incremental area under curve for free fatty acids

    The incremental area under curve for free fatty acids will be calculated using samples collected at 20 minute intervals between baseline and three hours

    Time frame: Over three hours from baseline

  2. The incremental area under curve for Triglycerides

    The incremental area under curve for Triglycerides will be calculated using samples collected at 20 minute intervals between baseline and three hours

    Time frame: Over three hours from baseline

  3. The incremental area under curve for Ghrelin

    The incremental area under curve for Ghrelin will be calculated using samples collected at one hour intervals between baseline and four hours

    Time frame: Over four hours from baseline

  4. The incremental area under curve for composite satiety score

    Composite satiety score will be calculated using 100mm visual analogue score ratings of satiety, fullness, hunger, desire to eat and prospective food consumption collected every 20 minutes between baseline and four hours.

    Time frame: Over four hours from baseline

  5. Weight of consumption of a pasta meal three hours after baseline

    Weight of pasta consumed from a bowel refilled prior to being empty until participants feel comfortably full

    Time frame: Three hours post baseline

  6. The incremental area under curve for cardiovascular parameters

    The incremental area under curve for mean blood pressure,cardiac output, stroke volume, peripheral resistance, heart rate, systolic blood pressure and diastolic blood pressure continuously over three hours from baseline using Finometer

    Time frame: Over three hours from baseline

  7. The incremental area under curve for limb blood flow

    The incremental area under curve for limb blood flow measured at 30 minute intervals between baseline and three hours using venous occlusion plethysmography

    Time frame: Over three hours from baseline

07

Study locations

1 site
  • University of Nottingham
    Nottingham, United Kingdom
08

References and documents

Individual participant data

Plan to share: No — only anonymised individual personal data will be shared, upon specific request from other researchers, for example, in order to undertake a meta analysis

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04172090
Responsible party
Sponsor
First posted
Nov 21, 2019
Start date
Oct 20, 2017
Primary completion
Mar 13, 2020
Completion
Mar 13, 2020
Last update
Mar 30, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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