## Protocol Section
### Identification Module
**NCT ID:** NCT03712579

**Brief Title:** Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses

**Official Title:** Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses: a Randomized Controlled Postprandial Study

#### Organization Study ID Info
**ID:** R18-P124
#### Organization
**Class:** OTHER
**Full Name:** Loughborough University
### Status Module
#### Completion Date
**Date:** 2020-10-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2022-05-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-10-15

**Type:** ACTUAL

#### Start Date
**Date:** 2019-01-21

**Type:** ACTUAL

**Status Verified Date:** 2022-05

#### Study First Post Date
**Date:** 2018-10-19
**Type:** ACTUAL
**Study First Submit Date:** 2018-06-06
**Study First Submit QC Date:** 2018-10-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Loughborough University

#### Responsible Party

**Investigator Affiliation:** Loughborough University

**Investigator Full Name:** Dr Oonagh Markey

**Investigator Title:** Vice-Chancellor's Research Fellow

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Cardiometabolic disorders are a leading cause of death worldwide. Replacing saturated fatty acids (SFA) with unsaturated fatty acids is recommended as a way of lowering cardiometabolic disease risk.

Consuming a diet rich in SFA may lead to a greater metabolic-inflammatory response in white adipose tissue during the fasting state, when compared to eating a diet rich in monounsaturated fatty acids (MUFA). Since individuals spend most of the day in the fed (or postprandial) state, it is important to see how different types of dietary fatty acids affect postprandial white adipose tissue and systemic metabolic-inflammatory responses.

This study will investigate the effect of a SFA-rich meal on markers of white adipose tissue and systemic metabolic-inflammation, compared to a MUFA-rich meal in overweight adults. In a randomised, single blind controlled, cross-over manner participants will consume either a SFA- or MUFA-rich meal and sequential blood and white adipose tissue samples will be collected before and until 6 hours postprandially.

### Conditions Module

**Conditions:**

- Inflammation

- Obesity

- Inflammatory Response

- Cardiovascular Diseases

- Overweight

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 8

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will consume a SFA-rich test meal (75g test fat) and sequential blood and white adipose tissue samples will be collected

**Intervention Names:**

- Dietary Supplement: SFA-Rich Meal

**Label:** SFA-Rich Meal

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will consume a MUFA-rich test meal (75g test fat) and sequential blood and white adipose tissue samples will be collected

**Intervention Names:**

- Dietary Supplement: MUFA-Rich Meal

**Label:** MUFA-Rich Meal

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SFA-Rich Meal

**Description:** Saturated fatty acid-rich test meal, containing 75g test fat

**Name:** SFA-Rich Meal

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- MUFA-Rich Meal

**Description:** Monounsaturated fatty acid-rich test meal, containing 75g test fat

**Name:** MUFA-Rich Meal

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** This will be assessed following the collection of white adipose tissue samples across the postprandial period

**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:** White adipose tissue samples will be collected at -0.5 (fasted), 1, 4 and 6 hours postprandially

#### Secondary Outcomes

**Description:** This will be assessed following the collection of blood samples

**Measure:** Systemic Markers of Inflammation (for example TNFa and IL-6 concentrations, determined using an ELISA)

**Time Frame:** Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially

**Description:** This will be assessed following the collection of white adipose tissue samples

**Measure:** Gene expression of key markers of metabolic inflammation in white adipose tissue

**Time Frame:** White adipose tissue samples will be collected at -0.5 (fasted), 1, 4 and 6 hours postprandially

**Description:** Assessed following the collection of blood samples

**Measure:** Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells (measured using flow cytometry analysis)

**Time Frame:** Blood samples will be collected at -0.5 (fasted) and 4 hours postprandially

**Description:** Assessed following the collection of blood samples

**Measure:** Serum Markers of Insulin Resistance

**Time Frame:** Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially

**Description:** Assessed following the collection of blood samples

**Measure:** Serum Lipid Profile (primarily triacylglycerol and non-esterified fatty acid concentrations, measured using a spectrophotometric assay)

**Time Frame:** Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18-50 years
* BMI = 25-40 kg/m2
* Male or Female
* Waist circumference \>94 cm (men) and \>80cm (women)\*
* Physically active (\> 3 x 30 min moderate intensity exercise per week)
* Systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg
* No cardiometabolic (e.g. heart disease, high blood pressure, type 2 diabetes) or inflammatory illness

  * NOTE: If waist circumference falls below 94 cm for men or 80cm for women but BMI is \>25 kg/m2 volunteers may still be recruited at the PI's discretion.

Exclusion Criteria:

* Smoker
* Previous diagnosis of anaemia
* Women who are pregnant or lactating
* Taking medication known to interfere with study outcomes (e.g. treatment for hyperlidaemia, hypertension, inflammation or hypercoagulation) or prescribed antibiotics within the last 3 months
* Taking nutritional supplements known to interfere with study outcomes (e.g. fish oil or evening primrose oil)
* Unstable weight history (\>3 kg loss or gain in the previous 3 months)
* An allergy to lidocaine
* Those with known or suspected food intolerances, allergies or hypersensitivity to any components of the meal (e.g. lactose/wheat intolerance)
* Alcohol consumption \>28 units per week for a man or \>21 units per week for a woman
* 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
* Parallel participation in another intervention study

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Loughborough

**Country:** United Kingdom

**Facility:** Loughborough University

**State:** Leicestershire

**Zip:** LE11 3TU

#### Overall Officials

**Official 1:**

**Affiliation:** Loughborough University

**Name:** Oonagh Markey, BSc, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000050177

- Term: Overweight

- ID: D000007249

- Term: Inflammation

### Misc Info Module

- Version Holder: 2024-05-24
