Full4Health: Understanding Food-gut-brain Axis Across the Lifecourse

Study Overview
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Brief Summary
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The primary aim of this work is, to 'relate psychological and behavioural parameters of hunger/satiety and food preference to gut hormones, neural activation and energy metabolism by dietary manipulation, across the human lifespan'.

Detailed Description
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The Full4Health project aims to further understanding of the mechanisms of hunger and satiety. The proposal integrates investigation of human volunteers and laboratory rodents throughout the life course, applying imaging and other cutting edge technologies to critical research questions. Full4Health will combine study of the mechanisms of hunger and satiety with intervention studies to validate the effects of the relevant food characteristics on the regulation of satiety/hunger. The development of cerebral responses to food through the gut-brain axis across lifespan particularly during childhood, adolescence and elderly will be studied.

Official Title
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Full4Health: Neuro-gut Interactions in Humans Across the Lifecourse

Conditions
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Obesity

Intervention / Treatment
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* Other: Breakfast Study
* Other: fMRI Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willingness to participate in the fMRI study Right-handed Not heavy smokers (less 10 day) MRI compatibility: no claustrophobia no metal in the body (including dental braces) Exclusion Criteria: Heavy smokers (more than 10/day) Morbid obese (BMI>40 kg/m2) Pregnancy Obesity of known endocrine origin Neurological disorders including Cerebral Palsy Alzheimers disease Multiple Sclerosis Parkinsons disease Medication known to influence appetite (orlistat, oral antidiabetics, insulin, digoxin, anti-arrhythmics, sibutramine, antidepressants) Self report fever/systemic infection Inability to participate in fMRI scanning sessions including contraindications to MRI Participation in medical or surgical weight loss programme within 1 month of selection History of cerebrovascular disease Current major depressive disorder, bipolar disorder or past history of suicide attempt or self harm History of drug or alcohol misuse History of significant cardiovascular disease Allergy to any of the breakfasts components.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1: Breakfast Study<br> | Other: Breakfast Study<br>* Participants (male and female, lean and obese, children, teenagers, adults, and elderly) will take part in 4 morning sessions, consuming a test breakfast milk based beverage and appetite. Biomarkers in blood will be measured and behavioural questionnaires completed. We will also collect a single saliva sample from each participant to examine genetic traits related to appetite, food choice, body weight, and energy expenditure. There will be two milk based beverages, one protein enriched (30% protein from calories) and one normal protein (15% protein). Participants will be offered a morning snack buffet to assess ad libitum energy intake. Phase 1 will also include a subgroup of malnourished male and female elderly participants. However, this group will only complete two morning sessions during which they will consume a low protein and a high protein milk based beverage. Appetite will be recorded and libitum energy intake will be measured. In addition, 24hr energy intake will be recorded.<br>|
| Experimental: Phase 2: fMRI Study<br> | Other: fMRI Study<br>* We will fMRI scan normal weight and overweight subjects of both gender from the four different age groups only: 8-10, 13-17, 24-45 and 65-75 years. Participants will be measured twice, on separate days, either after an overnight fast or after a test meal, fed to satiation (because hunger will modulate the response to food presentation). The participants will conduct a computerised task that will be performed in the scanner to assess hedonic responses to food cues. Physiological biomarkers will be measured during both trials for the assessment of appetite hormone circulation. Saliva samples will be taken for DNA analysis. DNA extraction techniques will be used to examine genetic traits linked to appetite, food choice, body weight, and energy expenditure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in concentrations of biomarkers of appetite in response to each milk-based beverage | The following blood-borne biomarkers of appetite will be measured: Glucose Total cholesterol Triglycerides Low density lipoprotein High density lipoprotein Insulin Ghrelin (active) Glucagon-like peptide-1 (active) Peptide YY (total) Leptin | During each of the four 'Breakfast Study' visits blood will be taken at baseline, and 30, 60, and 120 minutes after consuming the milk-based beverage. Each visit will be seperated by one week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural responses to images of food when fasted and after consuming a milk-based beverage | The subjects will conduct a computerised task that will be performed in the functional magnetic resonance imaging (fMRI) scanner. Subjects will be measured twice, on separate days, either after an overnight fast or after a test meal fed to satiation. | There will be one week between both conditions (fasted and fed) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food, appetite, gut, brain, satiety, hunger, gut hormones