Full4Health: Understanding Food-gut-brain Axis Across the Lifecourse (F4H)
This study is currently recruiting participants.
Verified August 2012 by University of Aberdeen
Sponsor:
University of Aberdeen
Collaborator:
European Union
Information provided by (Responsible Party):
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01597024
First received: May 7, 2012
Last updated: August 6, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Resource links provided by NLM:
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)
- GLP-1 (active)
- GIP (total)
- Peptide YY (total)
- Amylin (active)
- Leptin
- Cholecystokinin (CCK)
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.
| Estimated Enrollment: | 348 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Phase 1: Breakfast Study |
Other: Breakfast Study
Subjects (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 assess appetite, biomarkers in blood and saliva and complete questionnaires to assess influences on feeding behaviour. 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 are two milk based beverages, one protein enriched (30% protein from calories) and one normal protein (15% protein). Subjects will be offered a morning snack buffet to assess ad libitum feeding behaviour. Phase 1 will also include a subgroup of malnourished male and female elderly participants.
|
| 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. Subjects 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 subjects 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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597024
Contacts
| Contact: Alexandra M Johnstone, PhD | 01224438614 ext 8614 | alex.johnstone@abdn.ac.uk |
| Contact: William Buosi, MSc | 01224438691 ext 8691 | william.buosi@abdn.ac.uk |
Locations
| Greece | |
| Harokopia Univeristy | Active, not recruiting |
| Athens, Greece | |
| United Kingdom | |
| The Rowett Institute of Nutrition and Health, University of Aberdeen | Recruiting |
| Aberdeen, Aberdeenshire, United Kingdom, AB21 9SB | |
| Principal Investigator: Alexandra M Johnstone, PhD | |
| Sub-Investigator: Daniel Crabree, MSc | |
| Sub-Investigator: William Buosi, MSc | |
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:
No publications provided
| Responsible Party: | University of Aberdeen |
| ClinicalTrials.gov Identifier: | NCT01597024 History of Changes |
| Other Study ID Numbers: | Full4Health |
| Study First Received: | May 7, 2012 |
| Last Updated: | August 6, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013