Metabolic and Immune System Responses to a Mixed Meal

NCT02416843 | Completed

• 1 other identifier: 11/SW/0193
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 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. Knowledge of the role of adipose tissue itself has changed dramatically and it has emerged that in addition to storing energy as fats; adipose tissue secretes and responds to various chemical messengers in the body that are related to metabolism and inflammation. After a meal has been consumed, changes in metabolic (and some inflammatory) markers are seen in the blood, which may be influenced by metabolic and inflammatory changes occuring in the adipose tissue itself. The investigators therefore plan to investigate these changes in adipose tissue before and after a meal and compare them to changes occurring in the blood. They also plan to investigate whether these responses are different in people who are overweight compared to 'normal' weight. Participants will include males aged between 35-55 years who fit the criteria for inclusion. After taking some preliminary measurements and monitoring of normal daily activities, participants will attend one day of Laboratory testing in the Physiology Laboratories at the University of Bath. By investigating differences in metabolism and inflammation in adipose tissue and the circulation it is hoped that more will be learnt about the development of diseases associated with being overweight and ultimately help to develop more effective methods for prevention and treatment.

Conditions

Inflammation

Keywords

Adipose tissue; metabolism; inflammation; post-prandial; human

Outcome Measures

Primary Outcomes (1)

• Changes in IL6 mRNA expression in adipose tissue

  mRNA expression of IL6 will be measured in adipose tissue samples obtained pre and 6 hours post consumption of the mixed meal to assess for postprandial inflammatory changes in adipose tissue.

  6 hours

Secondary Outcomes (4)

• Changes in IL-6 secretion by adipose tissue

  6 hours

• Analysis of insulin stimulated pathways

  6 hours

• Characterisation of immune cell populations in adipose tissue

  6 hours

• Effect of adipocytes on T Lymphocyte activation

  6 hours

Study Arms (3)

Lean

EXPERIMENTAL

Consumption of a mixed meal relative to individual resting metabolic rate.

Other: Consumption of a mixed meal

Overweight

EXPERIMENTAL

Consumption of a mixed meal relative to individual resting metabolic rate.

Other: Consumption of a mixed meal

Obese

EXPERIMENTAL

Consumption of a mixed meal relative to individual resting metabolic rate.

Other: Consumption of a mixed meal

Interventions

Consumption of a mixed meal OTHER

Participants will consume a mixed meal and postprandial responses in blood and adipose tissue will be investigated over 6 hours and compared to baseline.

Lean; Obese; Overweight

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects should be:
• Nonsmokers
• Weight stable for more than 3 months

You may not qualify if:

• Subjects should not :
• have a personal history of/existing cardiovascular disease, metabolic disease or dyslipidaemia
• be taking medications that may influence lipid or carbohydrate metabolism
• have food intolerances/allergies to any component of the meal (i.e. dairy or wheat)
• Perform no more than 6 hours of strenuous physical activity or 10 hours of moderate intensity physical activity per week (as these individuals will not fit the meal standardisation procedure)

Sponsors & Collaborators

• University of Bath: lead
• Biotechnology and Biological Sciences Research Council: collaborator
• Unilever R&D: collaborator

Study Sites (1)

University of Bath - Department for Health

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

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dylan Thompson, PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

• James A Betts, PhD

  Univeristy of Bath

  PRINCIPAL INVESTIGATOR

• Alexandre C Motta, PhD

  Unilever R&D

  PRINCIPAL INVESTIGATOR

• Rebecca L Travers, PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 15, 2015
• Study Start: September 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

GB (1)