|- candidate number||27703|
|- NTR Number||NTR6637|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-jul-2017|
|- Secondary IDs||NL61997.099.17 CCMO op www.toetsingonline.nl|
|- Public Title||CasWhey study: Casein protein versus Whey protein|
|- Scientific Title||The effect of oral ingestion of casein protein versus whey protein on plasma amino acids, satiety and anorexigenic hormones after gastric bypass surgery|
|- ACRONYM||CasWhey study|
|- Healt Condition(s) or Problem(s) studied||Amino acid absorption , Gastric bypass surgery, Secretion of anorexigenic hormones|
|- Inclusion criteria||Female |
Gastric bypass surgery at age 18-65 years
Primary Roux-en-Y gastric bypass between 12 and 18 months ago
|- Exclusion criteria||Follow-up is not feasible|
Known allergies or intolerance to ingredients used in the intervention product
Medicine usage known to influence dietary uptake and/or appetite
o Lipid-lowering medication
o Systemic corticosteroids
Hypo- or hyperthyroidism
Known malabsorption syndrome
Known heart failure
Known renal insufficiency or failure
Known severe hepatic disease
Known severe symptomatic post gastric bypass hypoglycaemia
Active Diabetes Mellitus or remission
Former gastric operations
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||29-aug-2017|
|- planned closingdate||3-feb-2018|
|- Target number of participants||12|
|- Interventions||During two study visits the subjects will receive 200mL lactase-containing milk with either 15 g casein protein or 15 g whey protein as supplement in a blinded randomized order.|
|- Primary outcome||- To assess and compare the net incremental area under the curve of satiety-related plasma amino acids and derivatives in response to lactase-containing milk supplemented with either casein or whey protein in a randomized controlled cross over study in subjects 12-18 months after primary Roux-en-Y gastric bypass surgery. |
|- Secondary outcome||- To assess and compare the effect of the ingestion of both protein supplements in lactase-containing milk on plasma concentrations of all amino acids and derivatives, plasma concentrations of anorexigenic gastrointestinal hormones PYY and GLP-1, satiety, hunger, dumping symptoms, heart rate, blood pressure, glucose metabolism and ad libitum food intake after completion of the test meal in a randomized controlled cross over study in subjects 12-18 months after primary Roux-en-Y gastric bypass surgery.|
- To assess the self-reported dietary patterns, macronutrient consumption, energy intake, eating behaviour and physical activity measured by questionnaires in subjects 12-18 months after primary Roux-en-Y gastric bypass surgery.
|- Timepoints||12 subjects will receive either casein protein or whey protein in a randomized order during two visits with a period of minimally 1 week and maximally 3 weeks between them on the same day of the week. |
Each visit blood will be withdrawn through an intravenous catheter on 9 time points. An overview of the tubes is presented in Table 2. In total, 193.5 (21.5mL x 9 time points) mL blood will be withdrawn for the analyses per visit.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Arts-onderzoeker Merel van den Broek|
|- CONTACT for SCIENTIFIC QUERIES|| Loek de Heide|
|- Sponsor/Initiator ||Medical Center Leeuwarden |
(Source(s) of Monetary or Material Support)
|Medical Centrer Leeuwarden, University Campus Fryslan, University of Groningen, University Medical Centre Groningen. Department of Endocrinology|
|- Brief summary||Rationale: Dietary protein could be of potential great importance to improve postoperative outcomes after bariatric surgery given its effects in the non-surgical population on preservation of fat free mass, induction of satiety and prevention of protein malnutrition. And while the quantity of dietary protein is the main focus of interest in many studies, the amino acid composition of the ingested proteins may also be of importance. Our systematic review on the effect of dietary protein after gastric bypass surgery concluded there might be an essential beneficial role, but due to limited amount of literature and the diversity in main outcomes solid evidence could not be provided and more high quality research is needed. Results from our recent study showed that several plasma concentrations of amino acids were elevated in gastric bypass patients after a mixed meal tolerance test in those who experience more satiety and in those with higher concentrations of satiety-related (anorexigenic) hormones in 3.5 hours after ingestion of the test meal. This study points in the direction that a postprandial plasma amino acid profile comparable to casein protein is associated with both increased satiety and increased concentrations of satiety-related gastrointestinal hormones. However, in healthy and obese subjects whey protein induced more effect on satiety, active GLP-1 and insulin compared to casein protein. No studies with different types of proteins have been performed in gastric bypass patients.|
Objective: To investigate the effect of a test meal supplemented with casein protein in gastric bypass patients on concentrations of satiety-related plasma amino acids and satiety-related hormones and feelings of postprandial satiety and hunger compared to a test meal supplemented with whey protein.
Study design: This is a pilot study with a blinded randomized cross-over design. The recruitment will start in August 2017 and continue by approaching potential candidates consecutively.
Study population: In order to be eligible for participation in this study, subjects are women aged 18 to 65 years during their primary Roux-en-Y gastric bypass surgery 12-18 months ago at the Centre of Obesity Netherlands at the Medical Centre Leeuwarden. In total 12 subjects will be evaluated.
Intervention: During two study visits the subjects will receive 200mL lactase-containing milk with either 15 g casein protein or 15 g whey protein as supplement in a blinded randomized order.
Main study endpoint: The difference in net incremental area under the curves of the plasma concentrations of satiety-related amino acids and derivatives after ingestion of the two test meals.
|- Main changes (audit trail)|
|- RECORD||31-jul-2017 - 27-aug-2017|