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

NCT01597024 | Completed

• 1 other identifier: Full4Health
• Study Type: interventional
• Target: 718
• Locations: 3 countries
• Sites: 3

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'.

Conditions

Obesity

Keywords

appetite; food; gut; brain; satiety; hunger; gut hormones

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Neural responses to images of food when fasted and after consuming a milk-based beverage

  There will be one week between both conditions (fasted and fed)

Study Arms (2)

Phase 1: Breakfast Study

EXPERIMENTAL

Other: Breakfast Study

Phase 2: fMRI Study

EXPERIMENTAL

Other: fMRI Study

Interventions

Breakfast Study 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 1: Breakfast Study

fMRI Study 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.

Phase 2: fMRI Study

Eligibility Criteria

• Age: 8 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead
• European Union: collaborator

Study Sites (3)

Harokopia Univeristy

Athens, Greece

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

The Rowett Institute of Nutrition and Health, University of Aberdeen

Aberdeen, Aberdeenshire, AB21 9SB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34653498 DERIVED

Related Links

• Full4Health web-site

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra M Johnstone, PhD

  The Rowett Institute of Nutrition and Health, University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 11, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

GR (1); NL (1); GB (1)