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Trial registered on ANZCTR

Registration number

ACTRN12616001216404

Ethics application status

Approved

Date submitted

18/08/2016

Date registered

2/09/2016

Date last updated

8/08/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effects of whey protein, on energy intake, appetite, antral area, gastric emptying, amino acids, gut hormones and glucose in healthy, undernourished and obese, young and older, individuals

Scientific title

Effects of whey protein, on energy intake, appetite, antral area, gastric emptying, amino acids, gut hormones and glucose in healthy, undernourished and obese, young and 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

Obesity

Undernourishment

Condition category

Condition code

Diet and Nutrition

Obesity

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

The study will involve healthy, undernourished and obese, younger (18-50 years, n=16 in each group) and older (older than 65 years, n=16 in each group) adults. Healthy subjects will have a BMI of 22-30kg/m2, undernourished of <22 kg/m2 and obese subjects of 30-40kg/m2.

The participant receives a single 450mL preload per study visit in a randomised, crossover fashion of: i) 30 grams Whey Protein Isolate with diet lime cordial flavouring or ii) Water control with diet lime cordial flavouring. All preloads contain 100 microliter of 13C sodium acetate to enable measurement of gastric emptying via 13CO2 in the breath. Gastric emptying rate and intragastric meal distribution will be determined using 3D ultrasound.

Appetite sensation questionnaires in the form of a Visual Analog Scale (VAS) are measured and blood samples are collected for concentrations of gut hormones, amino acids and glucose.

A standard buffet meal is provided at 180 minutes following the preload and the participant has 30 minutes to eat until comfortably full. The buffet meal consists of 300ml orange juice, 600ml water, 375ml iced coffee, 4 slices white bread, 4 slices brown bread, 100g deli leg ham, 100g virginian chicken, 4 slices cheese, 100g tomato, 100g cucumber, 100g lettuce, 2 portions mayonnaise, 2 portions margarine, 1 medium apple, 1 medium banana, 200g chocolate custard, 150g fruit salad, 200g strawberry yoghurt, and a 14g milky way bar. Energy intake from this meal will be quantified.

Each volunteer receives one of each of the 2 treatments on each of the 2 study days. Each study visit is separated by no less than 3 days. Each visit lasts approximately 4 hours.

Intervention code [1]

Prevention

Comparator / control treatment

Placebo: a single 450mL water and diet lime cordial preload.

Control group

Placebo

Outcomes

Primary outcome [1]

Energy intake at buffet meal

Timepoint [1]

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). 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 (Foodworks 3.01, Xyris Software, Highgate Hill, QLD, Australia).

Primary outcome [2]

Gastric emptying rate assessed by three-dimensional (3D) ultrasonography

Timepoint [2]

3D ultrasound defines the fraction of the meal emptied from the stomach, including 50% emptying time (T1/2), during the study. Ultrasound images will be taken at t= -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165 and 180 min, where t=0 is at just after drink consumption.

Primary outcome [3]

Gastric emptying rate assessed by 13C sodium acetate breath test.

Timepoint [3]

The 13C sodium acetate breath test assesses gastric emptying of the protein drink through measurement of 13CO2 in the breath via mass spectrometry. Half-emptying time and gastric emptying coefficient will also be calculated and compared to those obtained using 3D ultrasonography. Breath samples will be taken at t= -15, 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165 and 180 min, where t=0 is at just after drink consumption.

Secondary outcome [1]

Blood pressure is determined using an automatic sphygmomanometer.

Timepoint [1]

Blood pressure is measured at -15 minutes, 0 minutes (straight after drink consumption) and every three minutes thereafter until 180 minutes. The final measurement is at 210 minutes after the buffet meal has been consumed.

Secondary outcome [2]

Heart rate is determined using an automatic sphygmomanometer.

Timepoint [2]

Heart rate is measured at -15 minutes, 0 minutes (straight after drink consumption) and every three minutes thereafter until 180 minutes. The final measurement is at 210 minutes after the buffet meal has been consumed.

Secondary outcome [3]

Plasma PYY concentrations

Timepoint [3]

Blood samples will be taken at t= -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 min, where t=0 is at just after drink consumption.

Secondary outcome [4]

Plasma ghrelin concentrations

Timepoint [4]

Blood samples will be taken at t= -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 min, where t=0 is at just after drink consumption.

Secondary outcome [5]

Plasma GLP-1 concentrations

Timepoint [5]

Blood samples will be taken at t= -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 min, where t=0 is at just after drink consumption.

Secondary outcome [6]

Plasma GIP concentrations

Timepoint [6]

Blood samples will be taken at t= -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 min, where t=0 is at just after drink consumption.

Secondary outcome [7]

Plasma CCK concentrations

Timepoint [7]

Blood samples will be taken at t= -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 min, where t=0 is at just after drink consumption.

Secondary outcome [8]

Plasma insulin concentrations

Timepoint [8]

Blood samples will be taken at t= -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 min, where t=0 is at just after drink consumption.

Secondary outcome [9]

Plasma glucagon concentrations

Timepoint [9]

Blood samples will be taken at t= -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 min, where t=0 is at just after drink consumption.

Secondary outcome [10]

Blood glucose concentrations

Timepoint [10]

Blood samples will be taken at t= -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 min, where t=0 is at just after drink consumption.

Secondary outcome [11]

Appetite sensations using a Visual Analog Scale (VAS) ( hunger, fullness, desire to eat, prospective food consumption, thirst).

Timepoint [11]

VAS is administered at time points: -15 minutes, 0 minutes (straight after drink consumption) and every fifteen minutes thereafter until 180 minutes. The final VAS is administered at 210 minutes after the buffet meal has been consumed.

Secondary outcome [12]

Gastrointestinal symptoms using a Visual Analog Scale (VAS) (bloating, nausea)

Timepoint [12]

Secondary outcome [13]

Amino acid concentrations

Timepoint [13]

Blood samples will be taken at t= -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 min, where t=0 is at just after drink consumption.

Eligibility

Key inclusion criteria

Healthy: BMI 22-30 kg/m2
Undernourished: BMI <22 kg/m2
Obese: BMI >30 kg/m2

Minimum age

18 Years

Maximum age

No limit

Sex

Males

Can healthy volunteers participate?

Key exclusion criteria

smokers of cigarettes/cigars/marijuana;

intake of >2 standard drinks on >5 days per week;

intake of >4 cups of caffeinated drinks per day;

intake of any illicit substance;

vegetarians;

lactose intolerance;

Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may effect gastrointestinal function or appetite - if subjects are willing, and able, to stop using medications, 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) for older subjects;

depression (a score >11 on the Geriatric Depression Questionnaire) for older subjects;

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.

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 and the researcher who performs the screening and who decides whether a subject is eligible to participate. The conditions were coded by a researcher who is not involved in the acquiring the data.

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

Subjects were randomised by a computer to either receive treatment (A) or placebo (B) on their first visit. 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
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

Recruiting

Date of first participant enrolment

Anticipated

Actual

1/09/2016

Date of last participant enrolment

Anticipated

1/09/2018

Actual

Date of last data collection

Anticipated

1/10/2018

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 6 Eleanor Harrald Building,
Frome Road,
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]

Royal Adelaide Hospital Research Ethics Committee

Ethics committee address [1]

Level 3, Hanson Institute, North Terrace
Adelaide, South Australia, 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/08/2016

Approval date [1]

08/08/2016

Ethics approval number [1]

R20120503

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. 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. Moreover, weight loss protein-rich diets are often recommended for obese older adults in the same manner as for younger adults. In young adults, obese individuals exhibit a less precise compensatory response to ingested energy than lean individuals. Although only a limited number of studies have examined the effects of state of nutrition in elderly on the regulation of appetite, there is persuasive evidence of substantial differences between undernourished and healthy older people, which may potentially represent an outcome of and/or contribute to the undernourished state. A common strategy to increase energy intake and body weight in undernourished elderly is the use of nutritional supplements, and this is now almost standard practice. Usually such supplements are provided as mixed macronutrient high-energy drinks. Because of the increasing awareness of the major muscle loss that preferentially accompanies weight loss in older people, and its particular adverse effects, there has been a recent, marked, increase in the preferential administration of protein in these supplements and the use of protein-enriched supplements in an attempt to preserve, or even increase, muscle mass, in both institutionalized and community-dwelling populations. Such recommendations and use are, however, largely empirical. Our understanding of the feeding responses, and mechanisms underlying them, of undernourished and obese older people to protein is very limited and will be increased greatly by the proposed study.

To aim of the study is to characterise in undernourished and obese, young and older individuals, the effect of different oral protein loads on energy intake, appetite, antral area, gastric emptying, plasma concentrations of amino acids, hormones (i.e. CCK, PYY, ghrelin, GLP-1, GIP, glucagon and insulin) and glucose, and to determine the relationship between the suppression of appetite and energy intake by protein with ‘intragastric’ and ‘small intestinal’ mechanisms.

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 6 Eleanor Harrald Building, Frome Road, Adelaide, SA 5000

Country

Australia

Phone

+61 8 8313 3638

Fax

stijn.soenen@adelaide.edu.au

Contact person for public queries

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

Phone

+61 8 8313 3638

Fax

stijn.soenen@adelaide.edu.au

Contact person for scientific queries

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

Phone

+61 8 8313 3638

Fax

stijn.soenen@adelaide.edu.au

No information has been provided regarding IPD availability

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No Supporting Document Provided

Results publications and other study-related documents

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