ObesityF4HNCT01597024
Full4Health: Understanding Food-gut-brain Axis Across the Lifecourse
A study testing Breakfast Study and fMRI Study in people with Obesity, run by University of Aberdeen at 3 sites in 3 countries.
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'. Read more about this study
- Who is it for?
- Ages 8 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Breakfast Study and fMRI Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 718 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
The Rowett Institute of Nutrition and Health, University of Aberdeen
Aberdeen, Aberdeenshire, AB21 9SB
About this study
Official title: Full4Health: Neuro-gut Interactions in Humans Across the Lifecourse
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'.
Read the 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.
- Conditions
- Obesity
- Being tested
- Breakfast Study, fMRI Study
- Keywords
- appetite, food, gut, brain, satiety, hunger, gut hormones
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast StudyOther
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 StudyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Breakfast Study | Experimental | Not described Receives: Other: Breakfast Study |
| Phase 2: fMRI Study | Experimental | Not described Receives: Other: fMRI Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Secondary outcomes (1)
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.
Measured: There will be one week between both conditions (fasted and fed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, Daniel Crabtree, University of Aberdeen
- Investigators
- Alexandra M Johnstone, PhD, Principal investigator, The Rowett Institute of Nutrition and Health, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597024
- Sponsor's protocol ID
- Full4Health
- Acronym
- F4H
- Status last verified
- May 2016
- First submitted
- 7 May 2012
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Crabtree DR, Buosi W, Fyfe CL, Horgan GW, Holst JJ, Johnstone AM; Full4Health-study Group. Salivary ghrelin response to drinks varying in protein content and quantity and association with energy intake and appetite. Physiol Behav. 2021 Dec 1;242:113622. doi: 10.1016/j.physbeh.2021.113622. Epub 2021 Oct 12.
PubMed 34653498
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full4Health: Neuro-gut Interactions in Humans Across the Lifecourse
- ClinicalTrials.gov ID
- NCT01597024
- Acronym / sponsor ID
- F4H / Full4Health
- Conditions
- Obesity
- Keywords
- appetite, food, gut, brain, satiety, hunger, gut hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- European Union
- Study start
- May 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Breakfast Study | Experimental | Other: Breakfast Study |
| Phase 2: fMRI Study | Experimental | Other: fMRI Study |
Who may qualify
- Ages
- 8 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Willingness to participate in the fMRI study
- Right-handed
- Not heavy smokers (less 10 day)
- MRI compatibility:
- no claustrophobia
Key exclusion criteria (17 listed)
- Heavy smokers (more than 10/day)
- Morbid obese (BMI>40 kg/m2)
- Pregnancy
- Obesity of known endocrine origin
- Neurological disorders including Cerebral Palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakfast StudyParticipants (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. | Other | Phase 1: Breakfast Study |
| fMRI StudyWe 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. | Other | Phase 2: fMRI Study |
Primary outcome
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.
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Derived from this study: PubMed 34653498Crabtree DR, Buosi W, Fyfe CL, Horgan GW, Holst JJ, Johnstone AM; Full4Health-study Group. Salivary ghrelin response to drinks varying in protein content and quantity and association with energy intake and appetite. Physiol Behav. 2021 Dec 1;242:113622. doi: 10.1016/j.physbeh.2021.113622. Epub 2021 Oct 12.
- Full4Health web-siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra M Johnstone, PhD principal investigator
The Rowett Institute of Nutrition and Health, University of Aberdeen
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast Study and fMRI Study in people with Obesity, run by University of Aberdeen at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01597024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.