Protein Intake and Satiety: a Postprandial Study

Satiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210544
• Other study ID #: 2019.069
• Status: Completed
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: December 5, 2019

Study information

• Verified date: December 2019
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 5, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Satiety

Intervention

Dietary Supplement:
• Experimental 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.
• Casein
Breakfast intake consisted on a 250 g custard intake mixed with 20 g of casein accompanied by a glass with 50 mL water.
• Water
Breakfast intake consisted on a 250 g custard intake mixed with 20 g of water accompanied by a glass with 50 mL water.

Locations

Country	Name	City	State
Spain	Centre for Nutrition Research, University of Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline subjective hunger	Visual analogue scale rating in a scale from 0 to 100 mm, for the quantification the perceived hunger before the experimental custard intake.	Baseline
Primary	Postprandial subjective hunger	Visual 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.	Up to 90 minutes
Primary	Baseline subjective fullness	Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived fullness before experimental custard intake.	Baseline
Primary	Postprandial subjective fullness	Visual 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.	Up to 90 minutes
Primary	Baseline subjective satiety	Visual analogue scale rating in a scale from 0 to100 mm for the quantification of the perceived fullness before experimental custard intake.	Baseline
Primary	Postprandial subjective satiety	Visual 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.	Up to 90 minutes
Primary	Baseline subjective desire to eat	Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived fullness before experimental custard intake at baseline.	Baseline
Primary	Postprandial subjective desire to eat	Visual 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.	Up to 90 minutes
Primary	Baseline subjective thirst	Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived fullness before experimental custard intake.	Baseline
Primary	Postprandial subjective thirst	Visual 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.	Up to 90 minutes
Primary	Baseline blood ghrelin concentration	Blood ghrelin concentration before experimental custard intake.	Baseline
Primary	Postprandial blood ghrelin concentration	Blood ghrelin concentration at 15, 30, 60 and 90 minutes after experimental custard intake.	Up to 90 minutes
Primary	Ad libitum food intake	Quantification of food intake after the 90 minutes of postprandial period.	90 minutes
Secondary	Baseline weight	Baseline weight of participants will be reported in kg and will be performed in the first visit.	Baseline
Secondary	Baseline height	Baseline height of participants will be reported in cm and will be performed in the first visit.	Baseline
Secondary	Baseline body mass index	To calculate baseline body mass index weight and height will be combined to report BMI in kg/m^2	Baseline
Secondary	Baseline waist circumference	Baseline waist circumference will be reported in cm and will be performed in the first visit	Baseline
Secondary	Baseline systolic blood pressure	Baseline systolic blood pressure will be reported in mmHg at each visit	Baseline
Secondary	Baseline diastolic blood pressure	Baseline diastolic blood pressure will be reported in mmHg at each visit	Baseline
Secondary	Baseline heart rate	Baseline heart rate will be reported in beat/minute at each visit	Baseline
Secondary	Baseline blood glucose concentration	Blood glucose levels before experimental custard intake	Baseline
Secondary	Postprandial blood glucose concentration	Blood glucose measured at 15, 30, 60 and 90 minutes after experimental custard intake.	Up to 90 minutes
Secondary	Baseline blood insulin concentration	Blood insulin levels before experimental custard intake	Baseline
Secondary	Postprandial blood insulin concentration	Blood insulin measured at 15, 30, 60 and 90 minutes after experimental custard intake.	Up to 90 minutes
Secondary	Baseline insulin resistance index (HOMA)	Insulin resistance index (HOMA) before experimental custard intake	Baseline
Secondary	Postprandial insulin resistance index (HOMA)	Insulin resistance index (HOMA) at 15, 30, 60 and 90 minutes after experimental custard intake.	Up to 90 minutes
Secondary	Baseline blood total cholesterol concentration	Blood total cholesterol concentration before experimental custard intake	Baseline
Secondary	Postprandial blood total cholesterol concentration	Blood total cholesterol concentration at 15, 30, 60 and 90 minutes after experimental custard intake.	Up to 90 minutes
Secondary	Baseline blood high density lipoprotein cholesterol (HDL) concentration	Blood high density lipoprotein cholesterol (HDL) concentration before experimental custard intake	Baseline
Secondary	Postprandial blood high density lipoprotein cholesterol (HDL) concentration	Blood high density lipoprotein cholesterol (HDL) concentration at 15, 30, 60 and 90 minutes after consuming 250 g of the experimental custard.	Up to 90 minutes
Secondary	Baseline blood low density lipoprotein cholesterol (LDL) concentration	Blood low density lipoprotein cholesterol (LDL) concentration before experimental custard intake	Baseline
Secondary	Postprandial blood low density lipoprotein cholesterol (LDL) cholesterol concentration	Low density lipoprotein cholesterol (LDL) concentration at 15, 30, 60 and 90 minutes after experimental custard intake	Up to 90 minutes
Secondary	Baseline blood triglyceride concentration	Blood triglyceride concentration before experimental custard intake	Baseline
Secondary	Postprandial blood triglyceride concentration	Blood triglyceride concentration at 15, 30, 60 and 90 minutes after experimental custard intake.	Up to 90 minutes
Secondary	Baseline blood cholecystokinin (CCK) concentration	Blood cholecystokinin (CCK) concentration before experimental custard intake	Baseline
Secondary	Postprandial blood cholecystokinin (CCK) concentration	Blood cholecystokinin (CCK) concentration at 15, 30, 60 and 90 minutes after experimental custard intake.	Up to 90 minutes
Secondary	Baseline blood glucagon like peptide-1 concentration	Blood glucagon like peptide-1 concentration concentration before experimental custard intake	Baseline
Secondary	Postprandial blood glucagon like peptide-1 concentration	Blood glucagon like peptide-1 concentration at 15, 30, 60 and 90 minutes after experimental custard intake.	Up to 90 minutes
Secondary	Baseline blood peptide YY (PYY) concentration	Blood peptide YY (PYY) concentration before experimental custard intake	Baseline
Secondary	Postprandial blood peptide YY (PYY) concentration	Blood peptide YY (PYY) concentration at 15, 30, 60 and 90 minutes after experimental	Up to 90 minutes
Secondary	Questionnaire about gastrointestinal symptoms (1)	Gastrointestinal questionnaire at 90 minutes of consuming the experimental custard.	90 minutes
Secondary	Questionnaire about gastrointestinal symptoms (2)	Gastrointestinal questionnaire before dinner of the experimental day.	Before dinner of the experimental day
Secondary	Quantification of food intake during the rest of the day	Food record calibration from the end of the ad libitum lunch until go to sleep.	During the whole day of the experimental day.
Secondary	Baseline blood apolipoprotein concentration	Blood apolipoproteins concentration before experimental custard intake	Baseline
Secondary	Postprandial blood apolipoprotein concentration	Blood apolipoprotein concentration at 15, 30, 60 and 90 minutes after experimental custard intake.	Up to 90 minutes
Secondary	Baseline blood concentration of reference amino acid of the experimental protein.	Baseline blood concentration of reference amino acids of the experimental protein.	Baseline
Secondary	Postprandial blood concentration of reference amino acid of the experimental protein	Blood concentration (15, 30, 60 and 90 minutes) of reference amino acid of the experimental protein after the experimental custard intake.	Up to 90 minutes
Secondary	Baseline urine concentration of reference amino acid of the experimental protein.	Baseline urine concentration of reference amino acid of the experimental protein.	Baseline
Secondary	Urine concentration of reference amino acid of the experimental protein at 90 minutes post ingestion	Urine concentration of reference amino acid of the experimental protein at 90 minutes post ingestion	90 minutes