Skip to main content
OpenTrials
Completed

NCT Number: NCT01597024

Full4Health: Understanding Food-gut-brain Axis 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'.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

8 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harokopia Univeristy, Athens, Greece

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

    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.

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • European Union

Registry information

Official study title

Full4Health: Neuro-gut Interactions in Humans Across the Lifecourse

Acronym: F4H

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 11, 2012
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.