Full4Health: Understanding Food-gut-brain Axis Across the Lifecourse (F4H)

University of Aberdeen

Status: Completed

Conditions: Obesity

Treatments: Other: Breakfast Study; Other: fMRI Study

Study type: Interventional

Funder types: Other

Identifiers

NCT01597024

Full4Health

Details and patient eligibility

About

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'.

Full 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.

Enrollment: 718 patients

Sex: All

Ages: 8 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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718 participants in 2 patient groups

Phase 1: Breakfast Study

Experimental group

Treatment:

Other: Breakfast Study

Phase 2: fMRI Study

Experimental group

Treatment:

Other: fMRI Study