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

NCT01597024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 718

Last updated 2016-05-20

No results posted yet for this study

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

Interventions

OTHER

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Alexandra M Johnstone, PhD · The Rowett Institute of Nutrition and Health, University of Aberdeen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-08-31
Completion
2015-10-31

Countries

  • Greece
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597024 on ClinicalTrials.gov