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

This study has been completed.
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Daniel Crabtree, University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01597024
First received: May 7, 2012
Last updated: May 19, 2016
Last verified: May 2016
  Purpose
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'.

Condition Intervention
Obesity
Other: Breakfast Study
Other: fMRI Study

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Full4Health: Neuro-gut Interactions in Humans Across the Lifecourse

Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • Changes in concentrations of biomarkers of appetite in response to each milk-based beverage [ Time Frame: 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. ] [ Designated as safety issue: No ]

    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:
  • Neural responses to images of food when fasted and after consuming a milk-based beverage [ Time Frame: There will be one week between both conditions (fasted and fed) ] [ Designated as safety issue: No ]
    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.


Enrollment: 718
Study Start Date: May 2012
Study Completion Date: October 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1: Breakfast Study 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.
Experimental: Phase 2: fMRI Study Other: 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.

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

Ages Eligible for Study:   8 Years to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597024

Locations
Greece
Harokopia Univeristy
Athens, Greece
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
United Kingdom
The Rowett Institute of Nutrition and Health, University of Aberdeen
Aberdeen, Aberdeenshire, United Kingdom, AB21 9SB
Sponsors and Collaborators
University of Aberdeen
European Union
Investigators
Principal Investigator: Alexandra M Johnstone, PhD The Rowett Institute of Nutrition and Health, University of Aberdeen
  More Information

Additional Information:
Responsible Party: Daniel Crabtree, Research Fellow, University of Aberdeen
ClinicalTrials.gov Identifier: NCT01597024     History of Changes
Other Study ID Numbers: Full4Health 
Study First Received: May 7, 2012
Last Updated: May 19, 2016
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Aberdeen:
appetite
food
gut
brain
satiety
hunger
gut hormones

ClinicalTrials.gov processed this record on December 08, 2016