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Trial registered on ANZCTR

Registration number

ACTRN12618000881235

Ethics application status

Approved

Date submitted

23/05/2018

Date registered

25/05/2018

Date last updated

25/05/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Dose-dependent effects of an oral protein load, on antral area, energy intake throughout the day, and perceptions of appetite in healthy older individuals

Scientific title

Dose-dependent effects of an oral protein load, on antral area, energy intake throughout the day, and perceptions of appetite in healthy older individuals

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Ageing

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Oral and Gastrointestinal

Normal oral and gastrointestinal development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A total of 15 healthy, older men aged 65-85 years with a body mass index (BMI) of 20-30 kg/m2 and 15 healthy, younger men aged 18-35 years with a BMI of 20-30 kg/m2 will be recruited.

Each subject will be studied on 3 occasions, separated by at least 3 days. On each occasion, they will receive, in randomized fashion, a drink containing either zero (control) 30 or 70 g loads of whey protein. Subjects will be asked to ingest the drink within 2 minutes. The drinks will be equivolaemic (~450 mL), controlled for osmolality and matched for taste, texture and appearance. The drinks will contain different quantities of food-grade whey protein isolate powder (Fonterra Australia Pty Ltd, Mt Waverley, Australia) dissolved in varying amounts of distilled water, sodium chloride and low-calorie lime cordial (Bickford’s ‘diet lime’ cordial). For example, the ‘control’ protein drink will contain 0 g protein, 1.2 g sodium chloride, 358.8 mL water and 90 mL cordial, ‘low protein’ load will contain 30 g of protein, 0.3 g sodium chloride, 334.7 mL water and 85 mL cordial, and the ‘high protein’ load will contain 70 g of protein, 0 g sodium chloride, 280 mL water and 100 mL cordial. The drinks will be covered all times, so the subject will be blinded for the treatment. Subjects will arrive at the laboratory ~8.00 am after fasting for ~12 hours overnight and refraining from exercise and alcohol for 24 hours. Subjects will be required to consume a standard meal the night before each study day (beef lasagne, McCain Foods Pty Ltd, Wendouree, VIC).

The drink will be administered at t = 0 (~8.30am) and energy intake will be assessed at breakfast t = 30 min (~9am), lunch t = 270 min (~1pm) and dinner t = 510 min (~5pm). Breakfast and lunch will be a buffet style meal and dinner will consist of a warm standardised meal e.g. a homogenous pasta dish. The weight of the foods will be recorded before and after it is offered to the subjects and energy intake and macronutrient composition calculated. Palatability of the drinks and meals will be measured with a questionnaire. VAS questionnaires will be collected 5 min before drink consumption (baseline), 0, 15 and 30 min after drink consumption, 5 min before and 0, 15 and 30 min after consumption of breakfast, lunch and dinner. A 2D ultra sound image of the stomach will be made at baseline (t=0), and after the consumption of the drink (t= 5, 15, 30). Subjects will only be allowed to consume water in between meal times. Subjects will be supervised by the researchers to monitor compliance. We will ask the subjects to record the amount of water consumed. Subjects will be reimbursed with $15 per hour for their time spent in the laboratory.

Intervention code [1]

Prevention

Comparator / control treatment

Placebo (‘control’ drink): 0 g protein, 1.2 g sodium chloride, 358.8 mL water and 90 mL cordial

Control group

Active

Outcomes

Primary outcome [1]

Total energy intake from (buffet) meals (breakfast, lunch, dinner) by weighing items of the buffet meal before and after consumption. FoodWorks (commercially available software) is used to calculate the energy content of the consumed food.

Timepoint [1]

t= 30 (breakfast), t=270 (lunch), t=510 (dinner)

Primary outcome [2]

Total macro nutrient intake from (buffet) meals (breakfast, lunch, dinner) by weighing items of the buffet meal before and after consumption. FoodWorks (commercially available software) is used to calculate the protein, carbohydrate and fat content of the consumed food.

Timepoint [2]

t= 30 (breakfast), t=270 (lunch), t= 510 (dinner)

Secondary outcome [1]

Hunger measured with visual analog scale questionnaires

Timepoint [1]

t= 0, 15, 30, 65, 80, 95, 270, 305, 315, 330, 505, 540, 555, 570

Secondary outcome [2]

Diameter of antral area measured with 2D-ultrasonography

Timepoint [2]

t= 0, 5, 15, 30

Secondary outcome [3]

Palatability of drinks and meals measured with a visual analog scale questionnaires

Timepoint [3]

t= 5 (drink), t= 65 (breakfast), t= 305 (lunch), t= 540 (dinner)

Secondary outcome [4]

Fullness measured with visual analog scale questionnaires

Timepoint [4]

t= 0, 15, 30, 65, 80, 95, 270, 305, 315, 330, 505, 540, 555, 570

Secondary outcome [5]

Desire to eat measured with visual analog scale questionnaires

Timepoint [5]

t= 0, 15, 30, 65, 80, 95, 270, 305, 315, 330, 505, 540, 555, 570

Secondary outcome [6]

Prospective food consumption measured with visual analog scale questionnaires

Timepoint [6]

t= 0, 15, 30, 65, 80, 95, 270, 305, 315, 330, 505, 540, 555, 570

Secondary outcome [7]

Nausea measured with visual analog scale questionnaires

Timepoint [7]

t= 0, 15, 30, 65, 80, 95, 270, 305, 315, 330, 505, 540, 555, 570

Secondary outcome [8]

Bloating measured with visual analog scale questionnaires

Timepoint [8]

t= 0, 15, 30, 65, 80, 95, 270, 305, 315, 330, 505, 540, 555, 570

Eligibility

Key inclusion criteria

Subjects will be required to be weight-stable (i.e. <5 % fluctuation in their body weight) at study entry, as determined by their self-reported weight in the preceding 3 months. Subjects will be asked to maintain their usual level of physical activity throughout the study.

Minimum age

18 Years

Maximum age

No limit

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

Each subject will be questioned prior to the study to exclude:
• smokers of cigarettes/cigars/marijuana;
• intake of >2 standard drinks on >5 days per week;
• intake of any illicit substance;
• vegetarians;
• use of prescribed medications which may affect appetite, body weight, gastrointestinal function or energy metabolism (e.g. domperidone and cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat);
• use of non-prescribed medications (including vitamins and herbal supplements) which may affect appetite, body weight, gastrointestinal function or energy metabolism (e.g. green tea extracts, Astragalus, St Johns Wort etc.) - if subjects are willing to stop using vitamins and/or supplements which affect gastrointestinal or energy metabolism during the study, a washout period of at least 14 days prior to the first test day will apply;
• food allergy(s), diabetes mellitus (fasting glucose >6.9 mmol/L), epilepsy, or gallbladder, pancreatic, cardiovascular or respiratory diseases;
• significant gastrointestinal symptoms, disease or surgery (apart from uncomplicated appendectomy), as determined by a questionnaire;
• impaired cognitive function (score <25 on Mini-Mental State Examination);
• depression (a score >11 on the Geriatric Depression Questionnaire);
• any other illness deemed significant by the investigator (including chronic illnesses not explicitly listed above);
• low ferritin levels (<20ug/l) and plasma Hb levels (130g/l), or blood donated in the 12 weeks prior to taking part in the study, in line with current Australian Red Cross Guidelines;
• individuals who are found to be unable to comprehend the study protocol.
Individuals whose blood glucose or HbA1c results are above the normal range or ferritin levels are low will be informed of the test results and advised to consult their GP. A letter will also be sent to their GP to notify them of the test results.

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)

Central randomisation by computer. The study has a within subjects design - all participants receive all interventions in randomised order. The allocation is blinded to the participant.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Subjects were randomised by a computer to either receive 30g or 70g protein, or placebo on their visits. The randomisation was designed to create random permutations of treatments for situations where subjects are to receive all of the treatments in random order. 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

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

4/06/2018

Actual

Date of last participant enrolment

Anticipated

1/04/2020

Actual

Date of last data collection

Anticipated

1/05/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Royal Adelaide Hospital Research Foundation - Clinical Project Grant

Address [1]

North Terrace
Adelaide, SA 5000

Country [1]

Australia

Primary sponsor type

Individual

Name

Stijn Soenen

Address

Discipline of Medicine, University of Adelaide
Attn.: Stijn Soenen
Level 5, Adelaide Health and Medical Sciences Building (AHMS)
Cnr North Terrace and George Street
Adelaide, SA, 5000

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Adelaide

Address [1]

North Terrace
Adelaide, SA 5000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

L3 Roma Mitchell House 
North Terrace 
Adelaide, SA, 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/04/2012

Approval date [1]

23/08/2013

Ethics approval number [1]

R120503

Summary

Brief summary

In older adults, insufficient protein intake facilitates muscle loss by limiting muscle anabolism. Furthermore, older people may experience ‘anabolic resistance’, increasing the threshold of protein required to stimulate postprandial protein anabolism (>25-30g). Importantly, providing that sufficient protein is ingested, ageing does not impair the capacity for muscle protein synthesis. Therefore, protein-rich supplements are commonly used to manage undernutrition in older people.
In younger adults, protein is known to be the most satiating macronutrient - high-protein diets are often advocated to promote weight loss. Therefore, the satiating effects of increased protein ingestion could counteract the positive effects of increased protein ingestion on lean mass in older people.
Interestingly, our studies have previously shown that suppression of energy intake after intraduodenal and oral whey protein loads is less in older compared to young people, despite slower gastric emptying and increased plasma CCK and GIP concentrations in the older subjects, factors which are associated with suppression of energy intake in young people. Timing of protein supplements (i.e. 3, 2, 1 hour(s) or just before a meal) did not affect energy intake at a subsequent meal. These studies suggest that older people have impaired appetite and energy intake regulation. The lack of suppression caused an increase in overall energy and protein intake, which supports the use of ‘pure’ protein supplements in undernourished older people.

The aim of the study is to characterise in healthy younger and older individuals, the effect of oral protein ingestion 30 min before breakfast, lunch and dinner on energy intake, appetite, blood glucose and plasma gut hormone concentrations (e.g. insulin, glucagon, ghrelin, CCK, GIP, GLP-1 and PYY).

We hypothesise that the acute suppression of appetite and energy intake by oral whey protein is less in healthy older than younger people.

To investigate this, a total of 15 healthy older men aged 65-85 years with a body mass index (BMI) of 20-30 kg/m2 and 15 healthy younger men aged 18-35 years with a BMI of 20-30 kg/m2 will be recruited.
Each subject will be studied on 3 occasions. On each occasion, they will receive, in randomized fashion, a drink of flavoured water (control; ~2 kcal) or a drinks of 30 g whey protein (120 kcal) 30 min before a breakfast (~9am, t = 30). Energy intake will be assessed at breakfast (t=30), lunch (t=270) and dinner (t=510). Blood samples will be taken, antral area will be measured and visual analog scales will completed at regular time intervals. Subjects will be allowed 30 min for all meals to freely consume food until they are comfortably full.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Stijn Soenen

Address

Discipline of Medicine, University of Adelaide Attn.: Stijn Soenen Level 5 Adelaide Health and Medical Sciences Building (AHMS), Cnr North Terrace and George Street, Adelaide, SA, 5000

Country

Australia

Phone

+61 8 8313 3638

Fax

[email protected]

Contact person for public queries

Name

Stijn Soenen

Address

Discipline of Medicine, University of Adelaide Attn.: Stijn Soenen Level 5 Adelaide Health and Medical Sciences Building (AHMS), Cnr North Terrace and George Street, Adelaide, SA, 5000

Country

Australia

Phone

+61 8 8313 3638

Fax

[email protected]

Contact person for scientific queries

Name

Stijn Soenen

Address

Discipline of Medicine, University of Adelaide Attn.: Stijn Soenen Level 5 Adelaide Health and Medical Sciences Building (AHMS), Cnr North Terrace and George Street, Adelaide, SA, 5000

Country

Australia

Phone

+61 8 8313 3638

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Whey protein drink ingestion before breakfast suppressed energy intake at breakfast and lunch, but not during dinner, and was less suppressed in healthy older than younger men.	2020	https://dx.doi.org/10.3390/nu12113318

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically