Plain English Summary
Background and study aims
The purpose of the study is to understand the preferences of elderly people when taking nutritional supplements rich in essential amino acids in different forms, and to see how these supplements affect their appetite. Through finding this out the researchers hope to ensure beneficial supplements can be designed in a form people will like. The study involves two experiments to investigate the effects of these supplements on appetite measures in the form of a nutritional Bar and Gel.
Who can participate?
Healthy volunteers aged between 60-80 years old.
What does the study involve?
There are two arms to the study. Each participant can choose whether to take part in both arms or just one. If they choose to take part in one arm, they can also decide which arm they wish to take part in. For arm 1, each participant attends the trial participating centre on three separate days. On each day, they take one of three tests. They do all three tests, on separate days, in a random order. The first test involves eating a nutritional bar rich in essential amino acids and then resting an hour before eating a breakfast of porridge. The second test involves eating a nutritional gel rich in essential amino acids and testing an hour before eating a breakfast of porridge. The third test involves not taking any nutritional supplements and just eating the porridge. All participants give blood samples throughout the tests and are asked to fill in questionnaires in the hour between eating the supplements and having breakfast. For arm 2, the participants again attend three sessions in a random order and eat nutritional supplements and/or breakfast as before. However, this time, those participants taking the supplements eat the breakfast at the same time, rather than waiting an hour and no blood samples are taken.
What are the possible benefits and risks of participating?
It is unlikely that participants will experience any long-term physiological benefits from taking part in this study. Blood samples will be taken by trained researchers using aseptic techniques and in accordance with local and national guidelines to minimise any risks.. Blood sample preparation will be separated from the testing area and participants to prevent cross-contamination and reduce the potential of any accidents. Deterioration of kidney function as result of eating a lot of protein can happen over a number of years, however only if the person already has kidney problems.. Due to the acute nature of the supplementation in this study even if a person is suffering from kidney problems the risk of making it worse by taking part in this study is very small.
Where is the study run from?
Leeds Beckett University (Carnegie Research Institute) and Higher Education Innovation Funding (HEIF) has been secured for this study.
When is study starting and how long is it expected to run for?
January 2015 to March 2016
Who is funding the study?
1. Leeds Beckett University
2. Higher Education Innovation Funding (HEIF)
Who is the main contact?
Dr Theocharis Ispoglou
T.Ispoglou@leedsbeckett.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Theocharis Ispoglou
ORCID ID
Contact details
Leeds Beckett University
Room 211 Fairfax Hall
Headingley Campus
Leeds
LS6 3QS
United Kingdom
+44 (0)113 812 8603
t.ispoglou@leedsbeckett.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
The impact of essential amino acid supplements enriched with L-leucine on appetite and energy intake in elderly: a randomised, crossover trial
Acronym
Study hypothesis
It is expected that essential amino acid based nutritional supplements enriched with L-leucine will not compromise appetite and energy intake in healthy elderly people.
Ethics approval
Leeds Beckett Local Research Ethics Committee, 18/02/2015
Study design
Randomised, crossover trial design
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
See additional files
Condition
Nutritional supplements
Intervention
There are two arms to the study. Each participant can choose whether to take part in both arms or just one. If they choose to take part in one arm, they can also decide which arm they wish to take part in.
Arm 1:
Each participant attends the trial participating centre on three separate days. on each day, they take one of three tests. They do all three tests, on separate days, in a random order. These tests are:
1. Consuming an essential amino acids based nutritional bar enriched with L-leucine: oral administration of a 37.5 g nutrition bar (134.5 kcal) containing 7.5 g of essential amino acids (40% L-Leucine)
2. Consuming an essential amino acids based nutritional gel enriched with L-leucine: oral administration of a 50 ml nutrition gel (113.9 kcal) containing 7.5 g of essential amino acids (40% L-Leucine)
3. No consumption of an essential amino acids based supplement
All participants then wait for an hour before consuming an ad-lib breakfast (standardised breakfast of porridge). During this hour, they are asked to complete questionnaires on hunger and opinion of the supplement consumed (if any).
At the start of each of the three sessions, a phlebotomist inserts a cannulla into a vein of each participant. Blood samples are taken at a number of occasions throughout the testing session for later hormonal response analysis.
Arm 2:
This arm of the study is very similar to arm 1. There are again three tests that all participants take part in over three days in a random order. These tests are almost identical to those of arm 1. However, this time the ad lib breakfast is eaten at the same time as the amino acid supplements are consumed (if any). Participants are also not required to give any blood samples.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Arm 1:
1. Composite appetite ratings using visual analogue scales, taken at baseline immediately post-consumption and every 15 min until post consumption of the ad lib breakfast
2. Energy intake, measured via the quantity of breakfast consumed
Arm 2:
Composite appetite ratings using visual analogue scales before and after the ad lib breakfast
Secondary outcome measures
Arm 1:
1. Gut hormone concentrations from blood samples, via plate reader and ELISA. Measurements to be taken at baseline immediately post-consumption and every 30 min until the ad lib breakfast
2. Plasma concentration of essential amino acids from blood samples, via gas chromatography mass spectrometry. Measurements to be taken at baseline immediately post-consumption and every 30 min until the ad lib breakfast
3. Palatability, measured using visual analogue scales. Measurements to be taken at baseline immediately post-consumption and every 15 min until post consumption of the ad lib breakfast
Arm 2:
Palatability, measured using visual analogue scales before and after the ad lib breakfast
Overall trial start date
01/01/2015
Overall trial end date
01/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female adults aged between 60 and 80
2. Free from vascular and metabolic disease
Participant type
Healthy volunteer
Age group
Senior
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Smoking
2. Use of oestrogens within the previous three months
3. Lactose intolerant
Recruitment start date
01/07/2015
Recruitment end date
01/10/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Carnegie Faculty, Leeds Beckett University
Room 211 Fairfax Hall
Headingley Campus
Leeds
LS6 3QS
United Kingdom
Sponsor information
Organisation
Leeds Beckett University
Sponsor details
510 The Rose Bowl
Portland Crescent
Leeds
LS1 3HB
United Kingdom
+44 (0) 113 81 29120
Andrew.Slade@leedsbeckett.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Higher Education Innovation Funding (HEIF)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Leeds Beckett University
Alternative name(s)
Leeds Beckett
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
1. Preliminary results ESPEN September 2016
2. Publication November 2016 (One article on females, and a case study article on men)
Intention to publish date
30/11/2016
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN12977929_PIS_30Jun16.docx - uploaded 13/07/2016)