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Protein Intake and Satiety: a Postprandial Study

Effect of a Protein Intake on the Feeling of Hunger / Satiety in Men and Women Through an Acute Postprandial Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04210544
Enrollment
48
Registered
2019-12-24
Start date
2019-07-17
Completion date
2019-12-05
Last updated
2019-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Satiety

Keywords

Satiety, Hunger, Obesity, Ghrelin, Visual Analogue Scale, Gastrointestinal hormones, Energy compensation

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.

Interventions

DIETARY_SUPPLEMENTExperimental dietary protein

Breakfast intake consisted on a 250 g custard intake mixed with 20 g of the experimental protein accompanied by a glass with 50 mL water.

DIETARY_SUPPLEMENTCasein

Breakfast intake consisted on a 250 g custard intake mixed with 20 g of casein accompanied by a glass with 50 mL water.

DIETARY_SUPPLEMENTWater

Breakfast intake consisted on a 250 g custard intake mixed with 20 g of water accompanied by a glass with 50 mL water.

Sponsors

Clinica Universidad de Navarra, Universidad de Navarra
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Baseline subjective hungerBaselineVisual analogue scale rating in a scale from 0 to 100 mm, for the quantification the perceived hunger before the experimental custard intake.
Postprandial subjective hungerUp to 90 minutesVisual analogue scale ratings in a scale from 0 to 100 mm for the quantification the perceived hunger measured at 15, 30, 45, 60, 75 and 90 minutes after experimental custard intake.
Baseline subjective fullnessBaselineVisual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived fullness before experimental custard intake.
Postprandial subjective fullnessUp to 90 minutesVisual analogue scale ratings in a scale from 0 to 100 mm for the quantification the perceived hunger measured at 15, 30, 45, 60, 75 and 90 minutes after experimental custard intake.
Baseline subjective satietyBaselineVisual analogue scale rating in a scale from 0 to100 mm for the quantification of the perceived fullness before experimental custard intake.
Postprandial subjective satietyUp to 90 minutesVisual analogue scale ratings in a scale from 0 to 100 mm for the quantification the perceived hunger measured at 15, 30, 45, 60, 75 and 90 minutes after experimental custard intake.
Baseline subjective desire to eatBaselineVisual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived fullness before experimental custard intake at baseline.
Postprandial subjective desire to eatUp to 90 minutesVisual analogue scale ratings in a scale from 0 to 100 mm for the quantification the perceived hunger measured at 15, 30, 45, 60, 75 and 90 minutes after experimental custard intake.
Baseline subjective thirstBaselineVisual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived fullness before experimental custard intake.
Postprandial subjective thirstUp to 90 minutesVisual analogue scale ratings in a scale from 0 to 100 mm for the quantification the perceived hunger measured at 15, 30, 45, 60, 75 and 90 minutes after experimental custard intake.
Baseline blood ghrelin concentrationBaselineBlood ghrelin concentration before experimental custard intake.
Postprandial blood ghrelin concentrationUp to 90 minutesBlood ghrelin concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Ad libitum food intake90 minutesQuantification of food intake after the 90 minutes of postprandial period.

Secondary

MeasureTime frameDescription
Postprandial insulin resistance index (HOMA)Up to 90 minutesInsulin resistance index (HOMA) at 15, 30, 60 and 90 minutes after experimental custard intake.
Baseline blood total cholesterol concentrationBaselineBlood total cholesterol concentration before experimental custard intake
Postprandial blood total cholesterol concentrationUp to 90 minutesBlood total cholesterol concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Baseline blood high density lipoprotein cholesterol (HDL) concentrationBaselineBlood high density lipoprotein cholesterol (HDL) concentration before experimental custard intake
Baseline blood low density lipoprotein cholesterol (LDL) concentrationBaselineBlood low density lipoprotein cholesterol (LDL) concentration before experimental custard intake
Postprandial blood low density lipoprotein cholesterol (LDL) cholesterol concentrationUp to 90 minutesLow density lipoprotein cholesterol (LDL) concentration at 15, 30, 60 and 90 minutes after experimental custard intake
Baseline blood triglyceride concentrationBaselineBlood triglyceride concentration before experimental custard intake
Postprandial blood triglyceride concentrationUp to 90 minutesBlood triglyceride concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Baseline blood cholecystokinin (CCK) concentrationBaselineBlood cholecystokinin (CCK) concentration before experimental custard intake
Postprandial blood cholecystokinin (CCK) concentrationUp to 90 minutesBlood cholecystokinin (CCK) concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Baseline blood glucagon like peptide-1 concentrationBaselineBlood glucagon like peptide-1 concentration concentration before experimental custard intake
Postprandial blood glucagon like peptide-1 concentrationUp to 90 minutesBlood glucagon like peptide-1 concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Baseline blood peptide YY (PYY) concentrationBaselineBlood peptide YY (PYY) concentration before experimental custard intake
Postprandial blood peptide YY (PYY) concentrationUp to 90 minutesBlood peptide YY (PYY) concentration at 15, 30, 60 and 90 minutes after experimental
Questionnaire about gastrointestinal symptoms (1)90 minutesGastrointestinal questionnaire at 90 minutes of consuming the experimental custard.
Questionnaire about gastrointestinal symptoms (2)Before dinner of the experimental dayGastrointestinal questionnaire before dinner of the experimental day.
Quantification of food intake during the rest of the dayDuring the whole day of the experimental day.Food record calibration from the end of the ad libitum lunch until go to sleep.
Postprandial blood high density lipoprotein cholesterol (HDL) concentrationUp to 90 minutesBlood high density lipoprotein cholesterol (HDL) concentration at 15, 30, 60 and 90 minutes after consuming 250 g of the experimental custard.
Postprandial blood apolipoprotein concentrationUp to 90 minutesBlood apolipoprotein concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Baseline blood concentration of reference amino acid of the experimental protein.BaselineBaseline blood concentration of reference amino acids of the experimental protein.
Postprandial blood concentration of reference amino acid of the experimental proteinUp to 90 minutesBlood concentration (15, 30, 60 and 90 minutes) of reference amino acid of the experimental protein after the experimental custard intake.
Baseline urine concentration of reference amino acid of the experimental protein.BaselineBaseline urine concentration of reference amino acid of the experimental protein.
Urine concentration of reference amino acid of the experimental protein at 90 minutes post ingestion90 minutesUrine concentration of reference amino acid of the experimental protein at 90 minutes post ingestion
Baseline blood apolipoprotein concentrationBaselineBlood apolipoproteins concentration before experimental custard intake
Baseline weightBaselineBaseline weight of participants will be reported in kg and will be performed in the first visit.
Baseline heightBaselineBaseline height of participants will be reported in cm and will be performed in the first visit.
Baseline body mass indexBaselineTo calculate baseline body mass index weight and height will be combined to report BMI in kg/m\^2
Baseline waist circumferenceBaselineBaseline waist circumference will be reported in cm and will be performed in the first visit
Baseline systolic blood pressureBaselineBaseline systolic blood pressure will be reported in mmHg at each visit
Baseline diastolic blood pressureBaselineBaseline diastolic blood pressure will be reported in mmHg at each visit
Baseline heart rateBaselineBaseline heart rate will be reported in beat/minute at each visit
Baseline blood glucose concentrationBaselineBlood glucose levels before experimental custard intake
Postprandial blood glucose concentrationUp to 90 minutesBlood glucose measured at 15, 30, 60 and 90 minutes after experimental custard intake.
Baseline blood insulin concentrationBaselineBlood insulin levels before experimental custard intake
Postprandial blood insulin concentrationUp to 90 minutesBlood insulin measured at 15, 30, 60 and 90 minutes after experimental custard intake.
Baseline insulin resistance index (HOMA)BaselineInsulin resistance index (HOMA) before experimental custard intake

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026