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

NCT ID: NCT01597024

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 718 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-10-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Phase 1: Breakfast Study

Group Type: EXPERIMENTAL

Breakfast Study

Intervention Type: OTHER

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.

Phase 2: fMRI Study

Group Type: EXPERIMENTAL

fMRI Study

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Union

OTHER

Sponsor Role: collaborator

University of Aberdeen

OTHER

Sponsor Role: lead

Responsible Party

Daniel Crabtree

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandra M Johnstone, PhD

Role: PRINCIPAL_INVESTIGATOR

The Rowett Institute of Nutrition and Health, University of Aberdeen

Locations

Harokopia Univeristy

Athens, , Greece

University Medical Center Utrecht

Utrecht, , Netherlands

The Rowett Institute of Nutrition and Health, University of Aberdeen

Aberdeen, Aberdeenshire, United Kingdom

Countries

Greece; Netherlands; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34653498 (View on PubMed)

Related Links

http://www.full4health.eu/

Full4Health web-site

Other Identifiers

Full4Health

Identifier Type: -

Identifier Source: org_study_id