InflammationNCT03569189
Impact of a High Saturated Fat Diet on Fasted Systemic and White Adipose Tissue Inflammatory Responses
A study testing High Fat Diet in people with Inflammation and Obesity, run by Loughborough University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Obesity, Inflammatory Response
- What is being tested?
- High Fat Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jul 2018to 23 Nov 2018
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
Official title: Impact of Short-term Overfeeding With a Saturated Fat-rich Diet on Fasted Systemic and White Adipose Tissue Inflammatory Responses
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.
- Conditions
- Inflammation, Obesity, Inflammatory Response, Cardiovascular Diseases
- Being tested
- High Fat Diet
- Medical subject headings
- Inflammation, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fat DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High Fat Diet | Experimental | 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. Receives: Other: High Fat Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein expression (content and phosphorylation) of key markers of metabolic inflammation in white adipose tissue (for example assessment of NFKB/IKBa total protein and phosphorylation by western blot analysis)
This will be assessed following the collection of fasted white adipose tissue samples
Measured: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Secondary outcomes (8)
Systemic Markers of Inflammation (for example CRP, TNFa and IL-6 concentrations, determined by spectrophotometric assay/ ELISA)
Assessed following the collection of fasted blood samples
Measured: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Gene expression of key markers of metabolic inflammation in white adipose tissue
This will be assessed following the collection of fasted white adipose tissue samples
Measured: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Fasting Serum Markers of Insulin Resistance (for example insulin and glucose concentrations, determined using an ELISA/ spectrophotometric assay)
Assessed following the collection of fasted blood samples
Measured: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Fasting Serum Lipid Profile (for example total, HDL and LDL cholesterol, TAG and NEFA concentrations, measured using a spectrophotometric assay)
Assessed following the collection of fasted blood samples
Measured: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Systemic Markers of Metabolic Endotoxemia (for example LBP and sCD14 concentrations, determined using an ELISA)
Assessed following the collection of fasted blood samples
Measured: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Immune Cell Populations in the Blood
Assessed following the collection of fasted blood samples
Measured: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Anthropometric Measurements (for example height and weight that will be aggregated to report BMI in kg/m^2)
Measured using standard equipment
Measured: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Physical Activity
Assessed using Actigraph accelerometers
Measured: Habitual physical activity will be assessed for 3 days prior to commencing the high-fat diet intervention (days 1-3) and during the final 3 days of the intervention (days 8-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start2 Jul 2018
- Primary completion23 Nov 2018
- Study completion23 Nov 2018
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Oonagh Markey, Loughborough University
- Investigators
- Oonagh Markey, BSc, PhD, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569189
- Sponsor's protocol ID
- R18-P040
- Status last verified
- Jan 2019
- First submitted
- 22 May 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32232380
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Short-term Overfeeding With a Saturated Fat-rich Diet on Fasted Systemic and White Adipose Tissue Inflammatory Responses
- ClinicalTrials.gov ID
- NCT03569189
- Acronym / sponsor ID
- R18-P040
- Conditions
- Inflammation, Obesity, Inflammatory Response, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 23 Nov 2018 (actual)
- First posted
- 26 Jun 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Fat Diet | Experimental | Other: High Fat DietParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-40 years
- BMI = 21.0-29.9 kg/m2
- Male or female
- Physically active (> 3 x 30 min moderate exercise per week)
- Healthy
Key exclusion criteria (12 listed)
- 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)
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 |
|---|---|---|
| High Fat DietParticipants 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. | Other | High Fat Diet |
Primary outcome
Protein expression (content and phosphorylation) of key markers of metabolic inflammation in white adipose tissue (for example assessment of NFKB/IKBa total protein and phosphorylation by western blot analysis)
Time frame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
This will be assessed following the collection of fasted white adipose tissue samples
8 secondary outcomes
Systemic Markers of Inflammation (for example CRP, TNFa and IL-6 concentrations, determined by spectrophotometric assay/ ELISA)
Time frame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Gene expression of key markers of metabolic inflammation in white adipose tissue
Time frame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Fasting Serum Markers of Insulin Resistance (for example insulin and glucose concentrations, determined using an ELISA/ spectrophotometric assay)
Time frame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Fasting Serum Lipid Profile (for example total, HDL and LDL cholesterol, TAG and NEFA concentrations, measured using a spectrophotometric assay)
Time frame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Systemic Markers of Metabolic Endotoxemia (for example LBP and sCD14 concentrations, determined using an ELISA)
Time frame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Immune Cell Populations in the Blood
Time frame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Anthropometric Measurements (for example height and weight that will be aggregated to report BMI in kg/m^2)
Time frame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Physical Activity
Time frame: Habitual physical activity will be assessed for 3 days prior to commencing the high-fat diet intervention (days 1-3) and during the final 3 days of the intervention (days 8-10)
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 4 Jan 2019.
- Derived from this study: PubMed 32232380Dewhurst-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.
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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.
Oonagh Markey, BSc, PhD principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Fat Diet in people with Inflammation and Obesity, run by Loughborough University 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 6 inclusion and 12 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 4 Jan 2019. 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?
Protein expression (content and phosphorylation) of key markers of metabolic inflammation in white adipose tissue (for example assessment of NFKB/IKBa total protein and phosphorylation by western blot analysis) (time frame: Change between pre- and post-high fat diet (assessed on days 4 and 11)). 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 NCT03569189, 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 4 Jan 2019.