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

Sedentary Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172090
• Other study ID #: I200317
• Status: Completed
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: March 13, 2020

Study information

• Verified date: November 2019
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Sedentary Behavior

Intervention

Other:
• Control
Normal physical activity and standard energy intake
• SIT+E
Reduced physical activity and standard energy intake
• SIT=E
Reduced physical activity and reduced energy intake

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Over three hours from baseline
Other	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	Over three hours from baseline
Other	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	Over four hours from baseline
Other	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.	Over four hours from baseline
Other	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	Three hours post baseline
Other	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	Over three hours from baseline
Other	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	Over three hours from baseline
Primary	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	Over three hours from baseline
Secondary	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	Over four hours from baseline