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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001216404
Enrollment
96
Registered
2016-09-02
Start date
2016-09-01
Completion date
2018-09-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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. A

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.

Sponsors

Stijn Soenen
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026