Clinical trial NCT01597024: Full4Health: Understanding Food-gut-brain Axis Across the Lifecourse
Official title: Full4Health: Neuro-gut Interactions in Humans Across the Lifecourse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: appetite
food
gut
brain
satiety
hunger
gut hormones
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2012-05-11
Enrollment: 718
Sex: ALL
Minimum age (years): 8
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in concentrations of biomarkers of appetite in response to each milk-based beverage
timeFrame: 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 outcomes:
measure: Neural responses to images of food when fasted and after consuming a milk-based beverage
timeFrame: There will be one week between both conditions (fasted and fed)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Harokopia Univeristy
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Aberdeen
country: United Kingdom
facility: The Rowett Institute of Nutrition and Health, University of Aberdeen
state: Aberdeenshire
Study officials:
affiliation: The Rowett Institute of Nutrition and Health, University of Aberdeen
name: Alexandra M Johnstone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crabtree DR, Buosi W, Fyfe CL, Horgan GW, Holst JJ, Johnstone AM; Full4Health-study Group. Salivary ghrelin response to drinks varying in protein content and quantity and association with energy intake and appetite. Physiol Behav. 2021 Dec 1;242:113622. doi: 10.1016/j.physbeh.2021.113622. Epub 2021 Oct 12.