Effects of Physical Inactivity on Insulin Sensitivity, Appetite, Energy Balance, and Cardiovascular Responses in Humans.
Primary Purpose
Sedentary Behavior
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Control
SIT+E
SIT=E
Sponsored by
About this trial
This is an interventional basic science trial for Sedentary Behavior
Eligibility Criteria
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:
- 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.
Sites / Locations
- University of Nottingham
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Control
SIT+E
SIT=E
Arm Description
2 consecutive days of standardised daily levels of moderate physical activity (PAL=1.85 reflecting their habitual levels), and matched energy (food) intake
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04172090
First Posted
November 19, 2019
Last Updated
March 27, 2020
Sponsor
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT04172090
Brief Title
Effects of Physical Inactivity on Insulin Sensitivity, Appetite, Energy Balance, and Cardiovascular Responses in Humans.
Official Title
Short-term Effects of Physical Inactivity on Insulin Sensitivity, Appetite, Energy Balance, and Cardiovascular Responses in Healthy Humans.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Behavior
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
2 consecutive days of standardised daily levels of moderate physical activity (PAL=1.85 reflecting their habitual levels), and matched energy (food) intake
Arm Title
SIT+E
Arm Type
Experimental
Arm Description
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
Arm Title
SIT=E
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Normal physical activity and standard energy intake
Intervention Type
Other
Intervention Name(s)
SIT+E
Intervention Description
Reduced physical activity and standard energy intake
Intervention Type
Other
Intervention Name(s)
SIT=E
Intervention Description
Reduced physical activity and reduced energy intake
Primary Outcome Measure Information:
Title
The incremental area under curve for Insulin
Description
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 Outcome Measure Information:
Title
The incremental area under curve for arterialized whole blood glucose
Description
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 Pre-specified Outcome Measures:
Title
The incremental area under curve for free fatty acids
Description
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
Title
The incremental area under curve for Triglycerides
Description
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
Title
The incremental area under curve for Ghrelin
Description
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
Title
The incremental area under curve for composite satiety score
Description
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
Title
Weight of consumption of a pasta meal three hours after baseline
Description
Weight of pasta consumed from a bowel refilled prior to being empty until participants feel comfortably full
Time Frame
Three hours post baseline
Title
The incremental area under curve for cardiovascular parameters
Description
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
Title
The incremental area under curve for limb blood flow
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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.
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
only anonymised individual personal data will be shared, upon specific request from other researchers, for example, in order to undertake a meta analysis
Learn more about this trial
Effects of Physical Inactivity on Insulin Sensitivity, Appetite, Energy Balance, and Cardiovascular Responses in Humans.
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