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Trial registered on ANZCTR


Registration number
ACTRN12615000070538
Ethics application status
Approved
Date submitted
9/01/2015
Date registered
27/01/2015
Date last updated
8/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of timing of protein ‘preloads’ on appetite and energy intake in healthy older individuals
Scientific title
Effects of timing of oral protein 'preloads', on energy intake, appetite, hormones, glucose and blood pressure in healthy older individuals
Secondary ID [1] 285937 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia of ageing 293865 0
Condition category
Condition code
Diet and Nutrition 294170 294170 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 294269 294269 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
16 healthy older subjects (65+ years) will be included in the study. In a randomised intervention order, the subjects will be studied on 5 occasions after an overnight fast. The study visits will be seperated by at least 3 days. Drink ingestion at 0, 60, 120 and 180 min of either whey protein isolate drink P or iso-palatable control drink C (~0kcal): i) P/C/C/C, ii) C/P/C/C, iii) C/C/P/C, iv) C/C/C/P and v) C/C/C/C (control study day). The protein drink will contain 30 g food-grade whey protein isolate powder dissolved in 70 mL distilled water and 50 mL low-calorie lime cordial (Bickfords diet lime cordial). The control drink will contain 90 mL distilled water and 40 mL low calorie lime cordial. The drinks will be equivolaemic (130 mL), and matched for taste. A baseline venous blood sample will be taken and the subject will complete a visual analogue scale (VAS) to assess appetite-related sensations. VAS questionnaires will be collected at t=-2 min (baseline) and t= 2, 27, 57, 62, 87, 117, 122, 147, 177, 182 and 212 min. Blood samples (11.4 mL each) will be collected at 7 time points t = -5 min (baseline) and t = 25, 55, 85, 115, 145, and 175 min). Blood pressure and heart rate will be measured prior to the drink (baseline) and at 3 minute intervals from t = 0 - 180 minutes and after the buffet meal t = 210 min. At t = 180 min, the intravenous cannula will be removed and subjects will be presented with a cold, buffet-style meal. Subjects will be allowed 30 min to freely consume food until they feel comfortably full. The weight of the foods will be recorded before and after it is offered to the subjects and energy intake and macronutrient composition calculated subsequently using commercially available software.
Intervention code [1] 290914 0
Prevention
Comparator / control treatment
Placebo: a single 130mL water and diet lime cordial preload.
Control group
Placebo

Outcomes
Primary outcome [1] 293960 0
Total energy intake of a standard buffet meal (quantified using Foodworks software).
Timepoint [1] 293960 0
Buffet meal is presented at 180 minutes after preload consumption and the subject is allowed to freely consume food until comfortably full for 30 minutes (until t= 210 minutes).
Primary outcome [2] 293961 0
Appetite sensations using a Visual Analogue Scale (VAS) (nausea, hunger, fullness, desire to eat, thirst).
Timepoint [2] 293961 0
VAS is administered at baseline (t=-2) and at time points 2, 27, 57, 62, 87, 117, 122, 147, 177, 182 and 212 min after preload consumption
Secondary outcome [1] 312236 0
Macronutrient intake of a standard buffet meal (quantified using Foodworks software).
Timepoint [1] 312236 0
Buffet meal is presented at 180 minutes after preload consumption and the subject is allowed to freely consume food until comfortably full for 30 minutes (until t= 210 minutes).
Secondary outcome [2] 312444 0
Systolic blood pressure is determined using an automatic sphygmomanometer.
Timepoint [2] 312444 0
Systolic blood pressure is measured prior to the drink (i.e. baseline mean of three samples, t = -9, -6, -3) and at 3 minute intervals from t = 0 – 180 minutes and after the buffet meal t = 210 min.
Secondary outcome [3] 312445 0
Diastolic blood pressure is determined using an automatic sphygmomanometer.
Timepoint [3] 312445 0
Diastolic blood pressure is measured prior to the drink (i.e. baseline mean of three samples, t = -9, -6, -3) and at 3 minute intervals from t = 0 – 180 minutes and after the buffet meal t = 210 min.
Secondary outcome [4] 312446 0
Heart rate is determined using an automatic sphygmomanometer.
Timepoint [4] 312446 0
Heart rate is measured prior to the drink (i.e. baseline mean of three samples, t = -9, -6, -3) and at 3 minute intervals from t = 0 – 180 minutes and after the buffet meal t = 210 min.
Secondary outcome [5] 312447 0
Cholecystokinin concentrations (CCK)
Timepoint [5] 312447 0
Blood samples will be taken at baseline (t=-5) and at time points 25, 55, 85, 115, 145, and 175 min after preload consumption
Secondary outcome [6] 312448 0
Glucagon-like peptide-1 (GLP-1) concentrations
Timepoint [6] 312448 0
Blood samples will be taken at baseline (t=-5) and at time points 25, 55, 85, 115, 145, and 175 min after preload consumption
Secondary outcome [7] 312449 0
Peptide YY (PYY) concentrations
Timepoint [7] 312449 0
Blood samples will be taken at baseline (t=-5) and at time points 25, 55, 85, 115, 145, and 175 min after preload consumption
Secondary outcome [8] 312450 0
Gastric inhibitory polypeptite (GIP) concentrations
Timepoint [8] 312450 0
Blood samples will be taken at baseline (t=-5) and at time points 25, 55, 85, 115, 145, and 175 min after preload consumption
Secondary outcome [9] 312451 0
Ghrelin concentrations
Timepoint [9] 312451 0
Blood samples will be taken at baseline (t=-5) and at time points 25, 55, 85, 115, 145, and 175 min after preload consumption
Secondary outcome [10] 312452 0
Glucagon concentrations
Timepoint [10] 312452 0
Blood samples will be taken at baseline (t=-5) and at time points 25, 55, 85, 115, 145, and 175 min after preload consumption
Secondary outcome [11] 312453 0
Insulin concentrations
Timepoint [11] 312453 0
Blood samples will be taken at baseline (t=-5) and at time points 25, 55, 85, 115, 145, and 175 min after preload consumption
Secondary outcome [12] 312454 0
Glucose concentrations
Timepoint [12] 312454 0
Blood samples will be taken at baseline (t=-5) and at time points 25, 55, 85, 115, 145, and 175 min after preload consumption

Eligibility
Key inclusion criteria
Body Mass Index (BMI): 22-30 kg/m2

Weight stable (<5% fluctuation in body weight in previous 3 months)

Age >65
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Significant gastrointestinal symptoms, disease, or surgery.

Current gallbladder or pancreatic disease; diabetes mellitus; epilepsy; cardiovascular or respiratory diseases; any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above).

Impaired cognitive function.

Depression.

Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may effect gastrointestinal function or appetite.

Lactose intolerant or other food allergies; intolerance or allergy to paracetomol.

Individuals with low ferritin levels or who have donated blood in the 12 weeks prior to taking part in the study.

Current intake of >2 standard drinks on >5 days per week.

Current smokers of cigarettes/cigars/marijuana.

Current intake of any illicit substance.

Experience claustrophobia in confined spaces.

Unable to comprehend study protocol.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers are asked to visit the clinic for a screening visit. A series of screening questionnaires are answered by the volunteer, and a blood sample is taken for determination of ferritin and HBA1C levels. Eligibility is determined based on the inclusion/exclusion criteria. A signed informed consent form is obtained and study dates are established. Eligible volunteers are assigned a subject number and randomised into a treatment for each study visit using a randomisation table. Randomisation involves contacting the holder of the randomisation table (study assistant) to inform them of the subjects details and study dates. The unblinded study assistant is therefore responsible for allocating a random treatment to the subject and preparing the preload on each study day.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation table was created using http://www.randomization.com/
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3309 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 9091 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 290522 0
Charities/Societies/Foundations
Name [1] 290522 0
Royal Adelaide Hospital Research Foundation - Clinical Project Grant
Address [1] 290522 0
North Terrace
Adelaide, SA 5000
Country [1] 290522 0
Australia
Primary sponsor type
Individual
Name
Stijn Soenen
Address
Discipline of Medicine, University of Adelaide
Attn.: Stijn Soenen
Level 6 Eleanor Harrald Building,
Frome Road,
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 289217 0
University
Name [1] 289217 0
University of Adelaide
Address [1] 289217 0
North Terrace
Adelaide, SA, 5000
Country [1] 289217 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292172 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 292172 0
Level 3, Hanson Institute, North Terrace
Adelaide, South Australia, 5000
Ethics committee country [1] 292172 0
Australia
Date submitted for ethics approval [1] 292172 0
06/11/2014
Approval date [1] 292172 0
12/11/2014
Ethics approval number [1] 292172 0
141109

Summary
Brief summary
Ageing is associated with a physiological reduction of appetite and energy intake, which has been called the “anorexia of ageing”. Dietary supplementation with liquid protein preparations is now used frequently to increase energy and protein intake in older adults in both institutionalized and community-dwelling populations. Although the latter would appear a logical approach, evidence for success of increased energy intake in older individuals is limited. It is well established that the ingestion of nutrients induce a number of changes in gastrointestinal (GI) function, which are associated with the modulation of appetite and energy intake. These changes include the slowing of gastric emptying, which sustains gastric distension and is associated with proximal gastric relaxation. Urgent investigation is warranted to determine the optimal load of protein that can be incorporated into their diet to assist in sparing muscle mass without reducing their appetite.

The study aims to characterise in healthy older individuals, the effect of timing of protein preloads on energy intake, appetite, plasma concentrations of hormones (i.e. CCK, PYY, ghrelin, GLP-1, GIP, glucagon and insulin) and glucose, and studies the relationship between the suppression of appetite and energy intake by protein.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53902 0
Dr Stijn Soenen
Address 53902 0
Discipline of Medicine, University of Adelaide Attn.: Stijn Soenen Level 6 Eleanor Harrald Building, Frome Road, Adelaide, SA 5000
Country 53902 0
Australia
Phone 53902 0
+61 8 8313 3638
Fax 53902 0
+61 8 8223 3870
Email 53902 0
stijn.soenen@adelaide.edu.au
Contact person for public queries
Name 53903 0
Dr Stijn Soenen
Address 53903 0
Discipline of Medicine, University of Adelaide Attn.: Stijn Soenen Level 6 Eleanor Harrald Building, Frome Road, Adelaide, SA 5000
Country 53903 0
Australia
Phone 53903 0
+61 8 8313 3638
Fax 53903 0
+61 8 8223 3870
Email 53903 0
stijn.soenen@adelaide.edu.au
Contact person for scientific queries
Name 53904 0
Dr Stijn Soenen
Address 53904 0
Discipline of Medicine, University of Adelaide Attn.: Stijn Soenen Level 6 Eleanor Harrald Building, Frome Road, Adelaide, SA 5000
Country 53904 0
Australia
Phone 53904 0
+61 8 8313 3638
Fax 53904 0
+61 8 8223 3870
Email 53904 0
stijn.soenen@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary