InflammationNCT02473835
Effects of a Short Term Caloric Restriction on T Cell Activation in Fat
A study testing Calorie restriction, Activity monitoring and Diet monitoring in people with Inflammation, run by University of Bath at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Calorie restriction, Activity monitoring and Diet monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Waist circumference > 94 cm
- Weight stable for more than 3 months (no change in weight +/- 3 %)
- Non-smoker
Who cannot join
- Personal history of/existing cardiovascular disease, metabolic disease or dyslipidaemia
- Taking medications that may influence lipid or carbohydrate metabolism or immune system function
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Bath - Department for Health
Bath, Bath and North East Somerset, BA2 7AY
About this study
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.
Read more
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.
Read the detailed description
The aim of this research is to investigate whether the immunometabolic properties of adipose tissue and the inflammatory cells located within it can be modified by short term changes in nutritional status.
Following advertisement of the study, interested potential participants will be asked to contact the Chief Investigator for further information via email/telephone correspondence. There will be an initial assessment of eligibility based on inclusion/exclusion criteria and, if these requirements are met, the potential participant will be invited to a meeting to further discuss the trial. After they have read the participant information sheet and seen the flowchart outlining the timeline for the study, if they would like to take part, they will be asked to sign a consent form. Dates will then be scheduled for some preliminary anthropometric measurements, 1 week of diet and physical activity monitoring and 3 days of calorie restriction with trial dates either side.
Preliminary measurements:
Preliminary testing will include anthropometric measurements of height, weight, waist and hip circumferences, sagittal waist height and blood pressure. Participants will also have their body composition precisely assessed using a dual energy X-ray absorptiometer (DEXA). These measurements will take place at the University of Bath Physiology Laboratories.
Monitoring of energy balance:
For 1 week, participants will be fitted with a physical activity monitor (Actiheart™) and asked to record a corresponding diary of their physical activity during this period to aid its interpretation and allow a more accurate calculation of average daily activity energy expenditure. Participants will also be asked to record their food and drink intake during this period so their corresponding energy intake during this period can be analysed and thus their 'energy balance' can be estimated. Participants should not make any conscious changes to their normal lifestyle habits/routines during this period. This analysis will then be used to write a 'diet prescription' for the 3 days to ensure the participant will receive 50 % of their 'normal' calorie intake using foods they would normally consume.
Main trial day 1:
In the 2 days prior to the first main trial day, participants should refrain from performing any strenuous physical activity. In the 24 hours prior, participants should also refrain from consuming any alcohol or caffeine. Participants should arrive at the Physiology Resting Laboratory in the morning following a 10 hour fast (approximately 8 am) where blood pressure will be measured and a saliva sample collected. A cannula will be inserted into a forearm vein and baseline blood sample(s) taken for analysis of metabolic/inflammatory markers and isolation of T cells. A fat sample will also be obtained using a needle aspiration technique. The participant will then be asked to consume a glucose drink consisting of 75 g anhydrous glucose (113 mL Polycal and 87 mL of water) and a cannula blood sample taken every 15 minutes for the following 2 hours.
Intervention - 3 day calorie restriction:
For the following 3 days, participants will be instructed to consume a diet calculated to be 50% of their 'normal' energy intake by reducing the proportions of the normal diet consumed. No strenuous physical activity should be performed by the participant for the last 2 days of this 3 day period and on the final day of this intervention, no caffeine or alcohol should be consumed.
Main trial day 2:
The following day after the 3 days of calorie restriction, participants will arrive at the laboratory at the same time as on main trial day 1 (to minimise variation in timing of sample collection) and will undergo exactly the same procedures.
Analysis:
On the day of the trial whole blood will be analysed for white blood cell count. Plasma and serum samples will be extracted from the whole blood via centrifugation and stored at -80 degrees C. Monocytes and T lymphocytes (populations of white blood cells) will also be isolated from whole blood and stored to later assess changes in their proportions and activation following the calorie restriction period. In each fat sample, separate portions of either adipose tissue or adipocytes (isolated from the other cells within the adipose tissue using a digestion method) will be cultured and media collected for later investigations. The remaining cells from the adipose tissue (SVF) will also be stored for later analysis of cell populations and their activation using flow cytometry, and expression/secretion analysis. mRNA expression will also be examined in adipose tissue.
- Conditions
- Inflammation
- Being tested
- Calorie restriction, Activity monitoring, Diet monitoring
- Keywords
- T-lymphocyte, Adipose tissue, Inflammation, Calorie restriction
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie restrictionOther
Participants will reduce calorie intake by 50 % for a period of 3 consecutive days.
Activity monitoringOther
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.
Diet monitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Calorie restriction; Other: Activity monitoring; Other: Diet monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (3)
Changes in T cell activation in blood in response to calorie restriction
T-lymphocytes will be isolated from blood samples taken before and after 3 days of 50 % calorie restriction and levels of their activation will be assessed by flow cytometry.
Measured: 3 days
Changes in IL-6 mRNA expression by adipose tissue
mRNA expression of IL6 will be measured in adipose tissue samples obtained before and after 3 days of 50 % calorie restriction to assess for inflammatory changes in adipose tissue.
Measured: 3 days
Changes in IL-6 secretion by adipose tissue
Adipose tissue explants will be cultured for 3 hours using samples obtained before and after 3 days of 50 % calorie restriction to assess for changes in IL-6 secretion.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startJan 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Unilever R&D
- Responsible party
- Principal investigator, Rebecca Travers, University of Bath
- Investigators
- Dylan Thompson, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473835
- Sponsor's protocol ID
- UoB - 3 day diet study
- Status last verified
- Jun 2015
- First submitted
- 9 Jun 2015
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25388403
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Short Term Caloric Restriction on T Cell Activation in Fat
- ClinicalTrials.gov ID
- NCT02473835
- Acronym / sponsor ID
- UoB - 3 day diet study
- Conditions
- Inflammation
- Keywords
- T-lymphocyte, Adipose tissue, Inflammation, Calorie restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Unilever R&D
- Study start
- Jan 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this research is to investigate whether the immunometabolic properties of adipose tissue and the inflammatory cells located within it can be modified by short term changes in nutritional status.
Following advertisement of the study, interested potential participants will be asked to contact the Chief Investigator for further information via email/telephone correspondence. There will be an initial assessment of eligibility based on inclusion/exclusion criteria and, if these requirements are met, the potential participant will be invited to a meeting to further discuss the trial. After they have read the participant information sheet and seen the flowchart outlining the timeline for the study, if they would like to take part, they will be asked to sign a consent form. Dates will then be scheduled for some preliminary anthropometric measurements, 1 week of diet and physical activity monitoring and 3 days of calorie restriction with trial dates either side.
Preliminary measurements:
Preliminary testing will include anthropometric measurements of height, weight, waist and hip circumferences, sagittal waist height and blood pressure. Participants will also have their body composition precisely assessed using a dual energy X-ray absorptiometer (DEXA). These measurements will take place at the University of Bath Physiology Laboratories.
Monitoring of energy balance:
For 1 week, participants will be fitted with a physical activity monitor (Actiheart™) and asked to record a corresponding diary of their physical activity during this period to aid its interpretation and allow a more accurate calculation of average daily activity energy expenditure. Participants will also be asked to record their food and drink intake during this period so their corresponding energy intake during this period can be analysed and thus their 'energy balance' can be estimated. Participants should not make any conscious changes to their normal lifestyle habits/routines during this period. This analysis will then be used to write a 'diet prescription' for the 3 days to ensure the participant will receive 50 % of their 'normal' calorie intake using foods they would normally consume.
Main trial day 1:
In the 2 days prior to the first main trial day, participants should refrain from performing any strenuous physical activity. In the 24 hours prior, participants should also refrain from consuming any alcohol or caffeine. Participants should arrive at the Physiology Resting Laboratory in the morning following a 10 hour fast (approximately 8 am) where blood pressure will be measured and a saliva sample collected. A cannula will be inserted into a forearm vein and baseline blood sample(s) taken for analysis of metabolic/inflammatory markers and isolation of T cells. A fat sample will also be obtained using a needle aspiration technique. The participant will then be asked to consume a glucose drink consisting of 75 g anhydrous glucose (113 mL Polycal and 87 mL of water) and a cannula blood sample taken every 15 minutes for the following 2 hours.
Intervention - 3 day calorie restriction:
For the following 3 days, participants will be instructed to consume a diet calculated to be 50% of their 'normal' energy intake by reducing the proportions of the normal diet consumed. No strenuous physical activity should be performed by the participant for the last 2 days of this 3 day period and on the final day of this intervention, no caffeine or alcohol should be consumed.
Main trial day 2:
The following day after the 3 days of calorie restriction, participants will arrive at the laboratory at the same time as on main trial day 1 (to minimise variation in timing of sample collection) and will undergo exactly the same procedures.
Analysis:
On the day of the trial whole blood will be analysed for white blood cell count. Plasma and serum samples will be extracted from the whole blood via centrifugation and stored at -80 degrees C. Monocytes and T lymphocytes (populations of white blood cells) will also be isolated from whole blood and stored to later assess changes in their proportions and activation following the calorie restriction period. In each fat sample, separate portions of either adipose tissue or adipocytes (isolated from the other cells within the adipose tissue using a digestion method) will be cultured and media collected for later investigations. The remaining cells from the adipose tissue (SVF) will also be stored for later analysis of cell populations and their activation using flow cytometry, and expression/secretion analysis. mRNA expression will also be examined in adipose tissue.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calorie Restriction | Experimental | Other: Calorie restriction, Other: Activity monitoring, Other: Diet monitoringParticipants 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. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Waist circumference > 94 cm
- Weight stable for more than 3 months (no change in weight +/- 3 %)
- Non-smoker
Key exclusion criteria (2 listed)
- Personal history of/existing cardiovascular disease, metabolic disease or dyslipidaemia
- Taking medications that may influence lipid or carbohydrate metabolism or immune system function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calorie restrictionParticipants will reduce calorie intake by 50 % for a period of 3 consecutive days. | Other | Calorie Restriction |
| Activity monitoringFor 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. | Other | Calorie Restriction |
| Diet monitoringFor 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. | Other | Calorie Restriction |
Primary outcome
Changes in T cell activation in adipose tissue in response to calorie restriction
Time frame: 3 days
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 secondary outcomes
Changes in T cell activation in blood in response to calorie restriction
Time frame: 3 days
Changes in IL-6 mRNA expression by adipose tissue
Time frame: 3 days
Changes in IL-6 secretion by adipose tissue
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2015.
- Background: PubMed 25388403Travers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan Thompson, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie restriction, Activity monitoring and Diet monitoring in people with Inflammation, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in T cell activation in adipose tissue in response to calorie restriction (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02473835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2015.