NCT02473835

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
Last Updated

June 17, 2015

Status Verified

June 1, 2015

Enrollment Period

1.8 years

First QC Date

June 9, 2015

Last Update Submit

June 12, 2015

Conditions

Keywords

T-lymphocyteAdipose tissueInflammationCalorie restriction

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

EXPERIMENTAL

Participants 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.

Other: Calorie restrictionOther: Activity monitoringOther: Diet monitoring

Interventions

Participants will reduce calorie intake by 50 % for a period of 3 consecutive days.

Calorie Restriction

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.

Calorie Restriction

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.

Calorie Restriction

Eligibility Criteria

Age35 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

University of Bath - Department for Health

Bath, Bath and North East Somerset, BA2 7AY, United Kingdom

Location

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

Inflammation

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Dylan Thompson, PhD

    Professor

    PRINCIPAL INVESTIGATOR

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

Locations