None listed
Conditions
Brief summary
We hypothesise that whey protein slows gastric emptying, stimulates “incretin” hormones and insulin secretion, and reduces glycaemia; that age and type 2 diabetes will modify these responses. The study aims to determine the acute effects of drinks containing either (i) whey protein, (ii) glucose, (iii) whey protein plus glucose, or (iv) control on blood gucose, insulin and gut hormones. A total of 20 older and 20 younger people with type 2 diabetesand 40 healthy controls, will be recruited. Blood samples, Gastric emptying, blood pressure, heart rate etc will be measured after taking informed consent. Completion of the study will provide us with useful data on gastric emptying of carbohydrates, protein and a combination of these nutrients, and on the effects of these nutrients on energy intake. This will give us novel and important information which can be translated to the community to improve overall health in older people.
Interventions
The proposed project consists of a randomized, double-blind, placebo-controlled, within-participants design. It aims to determine the acute effects of drinks containing either :
(i) 30g whey protein (120 kcal, 120 ml), (ii) 30g glucose (120 kcal, 120 ml), (iii) 30g glucose plus 30g whey protein (240 kcal, 120 ml), (iv) iso-palatable flavoured control drink (~2 kcal, 120 ml). All drinks will have a similar look, smell and taste. Participants will be studied during 4 study days and drinks will be
The proposed project consists of a randomized, double-blind, placebo-controlled, within-participants design. It aims to determine the acute effects of drinks containing either : (i) 30g whey protein (120 kcal, 120 ml), (ii) 30g glucose (120 kcal, 120 ml), (iii) 30g glucose plus 30g whey protein (240 kcal, 120 ml), (iv) iso-palatable flavoured control drink (~2 kcal, 120 ml). All drinks will have a similar look, smell and taste. Participants will be studied during 4 study days and drinks will be randomised over the study days. Both the participants and the investigators analysing the data will be blinded to the treatment allocation. Participants will attend the laboratory for a screening visit after reading the volunteer information sheet and after after signing the consent form a total of 20 older (aged 65 years or more) and 20 younger (aged 18 - 50 years) people with type 2 diabetes (managed by diet and/or metformin), and 40, age-, gender- and body-weight-matched, healthy controls, will be recruited. Each subject will be studied on 4 occasions. On each occasion, they will receive, in randomized fashion, any of the flavoured drinks as mentioned above. Participants will arrive at the laboratory ~8.00 am after fasting for ~12 hours overnight and refraining from exercise and alcohol for ~24 hours. Participants will be required to similar meal of their own choice the night before each study day and refrain from consuming anything other than water after 7pm. Upon arrival, an intravenous catheter will be inserted for blood sampling. Blood samples (~15 mL) will be collected at regular intervals (before the drink (0 mins) and 15, 30, 60, 90, 120, 180 min after ingestion of the drink), blood pressure and heart rate. 180 min after ingestion of the study drink, participants will be presented, with a standard, cold, buffet-style meal. A visual analogue scale (VAS) questionnaire to assess perceptions of appetite and gastrointestinal symptoms will be given. The wash out period would be 5 days in order to eliminate the effects of the drink, if any. Our PhD student will administer the drinks face to face individually and do the measurements at the Adelaide Health and Medical Sciences building.
Sponsors
Dr. Stijn Soenen
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria include male and female adults with a BMI of 22 kg/m2 or more. Patients with type 2 diabetes will have a HbA1c greater than or equal to 6.5% and less than or equal to 7.9% at the time of screening.
Exclusion criteria
Each subject will be questioned prior to the study to exclude: • smokers of cigarettes/cigars/marijuana; • intake of > 20 g alcohol on a daily basis; • vegetarians; • intake of any illicit substance; • requirement for insulin or other diabetes medications, other than metformin/DPP IV inhibitors; • significant gastrointestinal symptoms, or history of gastrointestinal disease including known gastroparesis, or surgery (other than appendectomy or cholecystectomy), proteinuria; • current use of medications which are likely to affect gastrointestinal function or appetite (e.g. opiates, anticholinergics, levodopa, calcium-channel antagonists, beta blockers, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, tegaserod, or erythromycin); • for women current pregnancy or lactation; • 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.); • any other illness deemed significant by the investigator (including chronic illnesses not explicitly listed above); • individuals who are found to be unable to comprehend the study protocol.
Outcome results
None listed