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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: fMRI Study; Other: Breakfast Study

• Registration Number: NCT01597024
• Lead Sponsor: University of Aberdeen

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-11
• Primary Completion: 2015-08
• Study Completion: 2015-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 718

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phase 2: fMRI Study	fMRI Study	-
Phase 1: Breakfast Study	Breakfast Study	-

Primary Outcome Measures

Name	Time	Method
Changes in concentrations of biomarkers of appetite in response to each milk-based beverage	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.	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

Secondary Outcome Measures

Name	Time	Method
Neural responses to images of food when fasted and after consuming a milk-based beverage	There will be one week between both conditions (fasted and fed)	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.

Trial Locations

Locations (3)

The Rowett Institute of Nutrition and Health, University of Aberdeen; 🇬🇧 Aberdeen, Aberdeenshire, United Kingdom

Harokopia Univeristy; 🇬🇷 Athens, Greece

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands