Impact of a High Saturated Fat Diet on Fasted Systemic and White Adipose Tissue Inflammatory Responses

NCT ID: NCT03569189

Last Updated: 2019-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-02

Study Completion Date

2018-11-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will investigate the effect of a 7-day westernised high-fat (65% of kilocalories), high-calorie (150% of requirements) diet on markers of inflammation in the blood and white adipose tissue. Participants will firstly complete a 3-day weight maintenance phase (Days 1-3) before completing a 7-day high fat diet intervention (Days 4-10). On days 4 and 11 participants will complete a laboratory visit where anthropometric measurements, blood and adipose samples will be collected.

The investigators hypothesise that consuming a high-fat, high-calorie diet for 7 days will alter the inflammatory responses in white adipose tissue and will induce metabolic endotoxaemia / systemic inflammation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammation Obesity Inflammatory Response Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High Fat Diet

Participants will consume a high-fat, high-calorie diet for 7 days (i.e. westernised diet) following a 3-day weight maintenance diet. Measurements will be made pre- and post-high fat diet intervention.

Group Type EXPERIMENTAL

High Fat Diet

Intervention Type OTHER

Participants will consume a high fat diet for 7 days with 65% of energy from fat. The diet will also provide an energy excess at 150% of energy requirements.

Participants will be provided with all of their meals and snacks throughout the study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High Fat Diet

Participants will consume a high fat diet for 7 days with 65% of energy from fat. The diet will also provide an energy excess at 150% of energy requirements.

Participants will be provided with all of their meals and snacks throughout the study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-40 years
* BMI = 21.0-29.9 kg/m2
* Male or female
* Physically active (\> 3 x 30 min moderate exercise per week)
* Healthy
* No cardiometabolic (e.g. heart disease, high blood pressure, type 2 diabetes) or inflammatory illness

Exclusion Criteria

* Inactive (\< 3 x 30 min moderate exercise per week)
* Smoker
* Women who are pregnant or lactating
* Medication/supplements known to interfere with study outcomes or prescribed antibiotics within the last 3 months
* Unstable weight history (≥3kg loss or gain in the previous 3 months)
* An allergy to lidocaine
* Food allergies (e.g. gluten, dairy) and intolerances (e.g. lactose) which could impede compliance to the diet
* Vegetarian/ vegan (as the high-fat diet is based on animal fats)
* Consumption of probiotics yogurts during or within the four weeks prior to the start of the study (e.g. Actimel, Activia, Yakult, Yeo Valley)
* Alcohol consumption \>28 units per week for a man (i.e. not more than 14 pints of beer or 28 small glasses of wine) or \>21 units per week for a woman (i.e. more than 10 and a half pints of beer or 21 small glasses of wine)
* Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention or metabolic study
* Restrained eaters (determined by Three Factor Eating Questionnaire)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Loughborough University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Oonagh Markey

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oonagh Markey, BSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Loughborough University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loughborough University

Loughborough, Leicestershire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Dewhurst-Trigg R, Wadley AJ, Woods RM, Sherar LB, Bishop NC, Hulston CJ, Markey O. Short-term High-fat Overfeeding Does Not Induce NF-kappaB Inflammatory Signaling in Subcutaneous White Adipose Tissue. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa158. doi: 10.1210/clinem/dgaa158.

Reference Type DERIVED
PMID: 32232380 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R18-P040

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.