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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04172090
Other study ID # I200317
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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