To investigate whether a test meal in gastric bypass patients with supplemented casein protein results in higher concentrations of satiety-related plasma amino acids and satiety-related hormones and leads to more postprandial satiety and less hunger…
ID
Source
Brief title
Condition
- Other condition
- Therapeutic procedures and supportive care NEC
Synonym
Health condition
Obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To assess and compare the net incremental area under the curve of
satiety-related plasma amino acids and derivatives (i.e. Alanine, Arginine,
Asparagine, Glutamine, Glycine, Histidine, Lysine, Phenylalanine, Serine,
Taurine, Threonine, α-aminobutyric acid) 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 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 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 gastric bypass surgery.
Background summary
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.
Study objective
To investigate whether a test meal in gastric bypass patients with supplemented
casein protein results in higher concentrations of satiety-related plasma amino
acids and satiety-related hormones and leads to more postprandial satiety and
less hunger compared to a test meal with supplemented whey protein.
Study design
This is a pilot study with a blinded randomized cross-over design. The
recruitment will start in November 2017 and continue by approaching potential
candidates consecutively. The anticipated ending of the study is April 2018.
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.
Study burden and risks
Burden: Subjects will be asked to visit the hospital twice after an overnight
fast apart from their routine follow-up visits. Every visit lasts approximately
5 hours. Questionnaires, a brief physical examination including weight and
length will be performed. The test meal consists of lactase-containing milk
with addition of either casein protein or whey protein. During the visit blood
will be withdrawn 9 times via an intravenous catheter. A total amount of
193.5mL blood will be withdrawn each visit. They are not allowed to drink, eat
or smoke during the visit.
Risks: blood withdrawal by placement of an intravenous catheter may cause
little discomfort by inducing pain and there is a low risk of bruising and
infection. The test meal and the protein supplements are commercially available
and no important risks are to be expected. Although intolerance to milk or soy
is an exclusion criterion, participants with unknown intolerance or allergies
could experience adverse effects.
Benefit: There are no personal direct benefits for the participants.
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
Inclusion criteria
Female
Gastric bypass surgery at age 18-65 years
Primary 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
Pregnancy
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL61997.099.17 |