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Effects of protein on gut hormones and motility, and appetite and energy intake in undernourished compared with healthy older individuals

Effects of intraduodenal protein, on energy intake, appetite, antropyloroduodenal motility, amino acids, hormones and glucose in undernourished compared with healthy older individuals

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000907842
Enrollment
24
Registered
2012-08-27
Start date
2012-09-10
Completion date
Unknown
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. There is consensus that nutrient stimuli in the gastrointestinal (GI) tract, especially in the small intestine, play a major role in the regulation of appetite and energy intake via modulation of GI motility and hormone release. Increasing our knowledge of how protein affects GI motility and hormone release is of increasing relevance in healthy and undernourished older individuals. In addition to the effects of healthy ageing, there is evidence of differences between undernourished and well-nourished older people, which may potentially result from being undernourished and/or contribute to the undernourished state. Urgent investigation is warranted to determine the effects of oral protein intake, so that protein can be incorporated into their diet to assist in sparing muscle mass without reducing their appetite. The study aims to characterise in older individuals, the effect of undernutrition on energy intake, appetite, antropyloroduodenal motility, plasma concentrations of amino acids, hormones (i.e. CCK, PYY, ghrelin, GLP-1, GIP, glucagon and insulin) and glucose after intraduodenal protein infusion.

Interventions

A single 60 minute intraduodenal infusion at 4mL/min of i) 0 kcal/min (saline control) ii) 1.5 kcal/min (Whey Protein Hydrolysate) in 12 undernourished and 12 'healthy' older subjects Appetite sensation questionnaires in the form of a Visual Analogue Scale (VAS), blood samples. A standard buffet meal will be provided at the end of the 60 minute infusion from which the volunteer has 30 minutes to eat until comfortably full. The buffet meal consists of 300ml orange juice, 600ml water, 375ml iced

A single 60 minute intraduodenal infusion at 4mL/min of i) 0 kcal/min (saline control) ii) 1.5 kcal/min (Whey Protein Hydrolysate) in 12 undernourished and 12 'healthy' older subjects Appetite sensation questionnaires in the form of a Visual Analogue Scale (VAS), blood samples. A standard buffet meal will be provided at the end of the 60 minute infusion from which the volunteer 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. Each volunteer will receive one of each infusion solution over 2 study days. Study visits will be seperated by no less than 3 days. Each study visit will last approximately 3-6 hours.

Sponsors

Dr Stijn Soenen
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Undernourished older people: at risk of malnourishment + malnourishment defined by a well validated, widely used, screening tool that is associated with poor outcomes in older people: the Mini Nutritional Assessment (MNA) with a score <24 out of 30 and, at least one of: self-reported weight loss in the previous 3 months, or a Body Mass Index (BMI) <22 kg/m2 'Healthy' older people: BMI: 20-30 kg/m2 Weight stable (<5% fluctuation in body weight in previous 3 months).

Exclusion criteria

Significant gastrointestinal symptoms, disease, or surgery. Current gallbladder or pancreatic disease; diabetes mellitus; epilepsy; cardiovasculr 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 tolerate nasogastrointestinal tube, or to comprehend study protocol.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026