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

Obesity Clinical Trial

— F4H  

Official title:

Full4Health: Neuro-gut Interactions in Humans Across the Lifecourse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597024
• Other study ID #: Full4Health
• Status: Completed
• Phase: N/A
• First received: May 7, 2012
• Last updated: May 19, 2016
• Start date: May 2012
• Est. completion date: October 2015

Study information

• Verified date: May 2016
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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'.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 718
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Breakfast Study
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.
• fMRI Study
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.

Locations

Country	Name	City	State
Greece	Harokopia Univeristy	Athens
Netherlands	University Medical Center Utrecht	Utrecht
United Kingdom	The Rowett Institute of Nutrition and Health, University of Aberdeen	Aberdeen	Aberdeenshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	European Union

Countries where clinical trial is conducted

Greece,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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)	No

External Links

•   Full4Health web-site