Clinical trial NCT04210544: Protein Intake and Satiety: a Postprandial Study
Official title: Effect of a Protein Intake on the Feeling of Hunger / Satiety in Men and Women Through an Acute Postprandial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satiety
Keywords: Satiety
Hunger
Obesity
Ghrelin
Visual Analogue Scale
Gastrointestinal hormones
Energy compensation
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Obesity is considered the emerging epidemic of the 21st century, becoming one of the major public health problems. Excessive body weight increases morbidity and mortality risk, while decreases the quality of life and expectance. The prevalence of obesity almost has doubled in the last 20 years. According to the World Health Organization, 39% of the population is overweight and 13% of the population is obese.

Obesity is a multifactorial origin disease, where genetic plays an important role. However, lifestyle factors, such as unhealthy diets and physical inactivity are the main cause for the development of obesity and associated comorbidities such as hypertension, dyslipidemia, diabetes and even some types of cancer. The prevention and control of obesity as well as its comorbidities requires interventions at individual and population level.

Intervention studies based on hypocaloric diets show poor adherence in the long term. Moreover, high energy density diets accompanied by snacking between meals contribute to weight gain. Therefore, the inclusion of bioactive compounds with satiating capacity within healthy and personalized dietary patterns could be a strategy to improve adherence in a dietary plan, and consequently reduce morbidity and mortality rates associated to obesity.

Considering this background, the general aim of this investigation is to perform an acute postprandial study to evaluate the effect of a dietary protein intake on the feeling of hunger and satiety. To carry out this objective, different data will be analysed, such as the measurement of gut hormone circulating concentrations, lipid and glucose profile, energy compensation after the postprandial period and the total energy intake during the day.

Detailed description: This study is designed as a crossover, randomized, three-arm postprandial study. All participants attend the Nutrition Intervention Unit of the Centre for Nutrition Research in the University of Navarra three times separated by at least one week. The day before each study day, participants should avoid vigorous physical exercise, alcohol consumption or high-fiber food consumption. Moreover, they are asked to follow a standardized dinner before 9 pm.

On each study day, participants visit the Nutrition Intervention Unit in fasting state. After 5 minutes rest and having answered the first hunger / satiety visual analogue scale (VAS) questionnaire, blood pressure is measured. After that, participant are asked to collect a baseline urine sample.

Once the cannulation is placed, first blood collection is performed in fasting state (time 0). Then, the participant is provided with the randomly assigned standardized breakfast (250 g of custard) with the addition of 20 g of experimental protein or 20 g of casein or 20 g of water. After custard consumption, volunteer is asked to drink 50 mL of water.

When participant finishes the breakfast, the time is registered and every 15 minutes the participant have to complete a VAS questionnaire (15´, 30´, 45´, 60´, 75´ and 90´). Moreover, blood samples are drawn at different time points after breakfast intake (15´, 30´, 60´ and 90´). The cannula is removed when the last blood sample is collected. In addition, participants are asked to collect the urine sample at 90 minutes postingestion and to fill a questionnaire about gastrointestinal symptoms.

Finally, participant is offered an ad libitum lunch (ham and cheese sandwiches) to eat until feeling comfortably satiated. Once completed, participant leaves the Centre for Nutrition Research with the necessary material to register the food intake (solids and liquids) during the rest of the day. Likewise, the participant is provided with the questionnaire of gastrointestinal symptoms to be filled before the dinner of the same day.

Eligibility criteria: Inclusion Criteria:

* Women and men aged 20-65 years.
* Overweight or obese (BMI: 24.9 - 34.9 kg / m2).
* Physical characteristics and vital signs normal or clinically without relevance to the experiment.
* Volunteers undergoing drug treatment will be included if the dose is stable for at least three months before the start of the study with the exception of treatments that alter gastrointestinal function, lipid lowering and antidiabetics treatments.
* Able to understand and be willing to sign the informed consent form and to follow all the study procedures and requirements.

Exclusion Criteria:

* Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasia, active peptic ulcers, chronic inflammatory diseases or malabsorption.
* Consuming more than 14 units of alcohol intake per week in women, or more than 21 units per week in men.
* Pregnancy or lactation.
* Subjects who have undergone surgical interventions with permanent sequelae (for example, gastroduodenostomy).
* Subjects with some liver disease.
* Subjects with some type of cancer or in treatment of it, or less than 5 years after its eradication.
* Subjects with allergy to any component of the products under study or some other food that interferes and makes difficult to follow the study.
* Subjects that present some kind of cognitive and / or psychical impairment.
* Subjects with poor collaboration, or with difficulty to follow the study procedures.
* Subjects who exhibit restrictive or specific behaviors in the diet (Eating Attitude Test-26 equal or more than 20 points).

Primary outcomes:
measure: Baseline subjective hunger
timeFrame: Baseline
measure: Postprandial subjective hunger
timeFrame: Up to 90 minutes
measure: Baseline subjective fullness
timeFrame: Baseline
measure: Postprandial subjective fullness
timeFrame: Up to 90 minutes
measure: Baseline subjective satiety
timeFrame: Baseline
measure: Postprandial subjective satiety
timeFrame: Up to 90 minutes
measure: Baseline subjective desire to eat
timeFrame: Baseline
measure: Postprandial subjective desire to eat
timeFrame: Up to 90 minutes
measure: Baseline subjective thirst
timeFrame: Baseline
measure: Postprandial subjective thirst
timeFrame: Up to 90 minutes
measure: Baseline blood ghrelin concentration
timeFrame: Baseline
measure: Postprandial blood ghrelin concentration
timeFrame: Up to 90 minutes
measure: Ad libitum food intake
timeFrame: 90 minutes
Secondary outcomes:
measure: Baseline weight
timeFrame: Baseline
measure: Baseline height
timeFrame: Baseline
measure: Baseline body mass index
timeFrame: Baseline
measure: Baseline waist circumference
timeFrame: Baseline
measure: Baseline systolic blood pressure
timeFrame: Baseline
measure: Baseline diastolic blood pressure
timeFrame: Baseline
measure: Baseline heart rate
timeFrame: Baseline
measure: Baseline blood glucose concentration
timeFrame: Baseline
measure: Postprandial blood glucose concentration
timeFrame: Up to 90 minutes
measure: Baseline blood insulin concentration
timeFrame: Baseline
measure: Postprandial blood insulin concentration
timeFrame: Up to 90 minutes
measure: Baseline insulin resistance index (HOMA)
timeFrame: Baseline
measure: Postprandial insulin resistance index (HOMA)
timeFrame: Up to 90 minutes
measure: Baseline blood total cholesterol concentration
timeFrame: Baseline
measure: Postprandial blood total cholesterol concentration
timeFrame: Up to 90 minutes
measure: Baseline blood high density lipoprotein cholesterol (HDL) concentration
timeFrame: Baseline
measure: Postprandial blood high density lipoprotein cholesterol (HDL) concentration
timeFrame: Up to 90 minutes
measure: Baseline blood low density lipoprotein cholesterol (LDL) concentration
timeFrame: Baseline
measure: Postprandial blood low density lipoprotein cholesterol (LDL) cholesterol concentration
timeFrame: Up to 90 minutes
measure: Baseline blood triglyceride concentration
timeFrame: Baseline
measure: Postprandial blood triglyceride concentration
timeFrame: Up to 90 minutes
measure: Baseline blood cholecystokinin (CCK) concentration
timeFrame: Baseline
measure: Postprandial blood cholecystokinin (CCK) concentration
timeFrame: Up to 90 minutes
measure: Baseline blood glucagon like peptide-1 concentration
timeFrame: Baseline
measure: Postprandial blood glucagon like peptide-1 concentration
timeFrame: Up to 90 minutes
measure: Baseline blood peptide YY (PYY) concentration
timeFrame: Baseline
measure: Postprandial blood peptide YY (PYY) concentration
timeFrame: Up to 90 minutes
measure: Questionnaire about gastrointestinal symptoms (1)
timeFrame: 90 minutes
measure: Questionnaire about gastrointestinal symptoms (2)
timeFrame: Before dinner of the experimental day
measure: Quantification of food intake during the rest of the day
timeFrame: During the whole day of the experimental day.
measure: Baseline blood apolipoprotein concentration
timeFrame: Baseline
measure: Postprandial blood apolipoprotein concentration
timeFrame: Up to 90 minutes
measure: Baseline blood concentration of reference amino acid of the experimental protein.
timeFrame: Baseline
measure: Postprandial blood concentration of reference amino acid of the experimental protein
timeFrame: Up to 90 minutes
measure: Baseline urine concentration of reference amino acid of the experimental protein.
timeFrame: Baseline
measure: Urine concentration of reference amino acid of the experimental protein at 90 minutes post ingestion
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Centre for Nutrition Research, University of Navarra
state: Navarra
Study officials:
affiliation: Centre for Nutrition Research - University of Navarra
name: M Ángeles Zulet Alzórriz, Professor
role: PRINCIPAL_INVESTIGATOR
References: