Effects of a Short Term Caloric Restriction on T Cell Activation in Fat
1 other identifier
interventional
12
1 country
1
Brief Summary
Overweight and obesity are major problems and their complications such as cardiovascular disease and type 2 diabetes mellitus pose great burdens on healthcare systems. There is accumulating evidence to support obesity being a chronic inflammatory disorder mediated in part by the expansion of adipose (fat) tissue. In addition to adipocytes (fat cells), adipose tissue contains a whole range of other cell types including some immune (white blood) cells. The relative proportions of immune cell subpopulations and interactions between the different cell types within adipose tissue may be important in the development of type 2 diabetes. Previous research by the investigators has suggested that there may be important differences in the activation status of certain immune cells located in adipose tissue with increased overweight and the production of leptin - an appetite regulating hormone. Properties of adipose tissue and inflammatory cells located within it may therefore be sensitive to changes in our nutritional status. The purpose of the present study is to investigate changes in T cell activation in adipose tissue alongside other immunometabolic properties before and after a short period of dieting compared to changes in blood. Participants will include males aged between 35-55 years old who meet the criteria for inclusion. After taking some preliminary measurements and monitoring of normal daily activities, participants will reduce their calorie intake to 50 % of their normal intake/requirements for 3 consecutive days and will attend 1 session of Laboratory testing before and 1 after this period which will take place in the Physiology Laboratories at the University of Bath. It is hoped that investigating immunometabolic responses within adipose tissue following an acute nutritional challenge will help lead to a better understanding of the development of diseases associated with being overweight and ultimately help in the development of more effective methods for prevention and treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 17, 2015
CompletedJune 17, 2015
June 1, 2015
1.8 years
June 9, 2015
June 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in T cell activation in adipose tissue in response to calorie restriction
T-lymphocytes will be isolated from adipose tissue samples taken before and after 3 days of 50 % calorie restriction and levels of their activation will be assessed by flow cytometry.
3 days
Secondary Outcomes (3)
Changes in T cell activation in blood in response to calorie restriction
3 days
Changes in IL-6 mRNA expression by adipose tissue
3 days
Changes in IL-6 secretion by adipose tissue
3 days
Study Arms (1)
Calorie Restriction
EXPERIMENTALParticipants reduced calorie intake by 50 % for a period of 3 consecutive days - the target calorie intake for each participant will be determined by a period of energy balance (diet and activity) monitoring.
Interventions
Participants will reduce calorie intake by 50 % for a period of 3 consecutive days.
For 1 week, participants will be fitted with an activity monitor (Actiheart) to estimate energy expenditure (during the same week as the diet monitoring). The activity and diet monitoring data will be used together to confirm that participants are in a state of energy balance and an average of these 2 values taken - 50 % of this average value will be the target calorie intake for the 3 day calorie restriction period.
For 1 week, participants will be asked to record all food and fluids consumed to estimate energy intake (during the same week as the activity monitoring). The activity and diet monitoring data will be used together to confirm that participants are in a state of energy balance and an average of these 2 values taken - 50 % of this average value will be the target calorie intake for the 3 day calorie restriction period.
Eligibility Criteria
You may qualify if:
- Waist circumference \> 94 cm
- Weight stable for more than 3 months (no change in weight +/- 3 %)
- Non-smoker
You may not qualify if:
- Personal history of/existing cardiovascular disease, metabolic disease or dyslipidaemia
- Taking medications that may influence lipid or carbohydrate metabolism or immune system function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bathlead
- Biotechnology and Biological Sciences Research Councilcollaborator
- Unilever R&Dcollaborator
Study Sites (1)
University of Bath - Department for Health
Bath, Bath and North East Somerset, BA2 7AY, United Kingdom
Related Publications (1)
Travers RL, Motta AC, Betts JA, Bouloumie A, Thompson D. The impact of adiposity on adipose tissue-resident lymphocyte activation in humans. Int J Obes (Lond). 2015 May;39(5):762-9. doi: 10.1038/ijo.2014.195. Epub 2014 Nov 12.
PMID: 25388403BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dylan Thompson, PhD
Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 9, 2015
First Posted
June 17, 2015
Study Start
January 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
June 17, 2015
Record last verified: 2015-06