SatietyNCT04210544
Protein Intake and Satiety: a Postprandial Study
A study testing Experimental dietary protein, Casein and Water in people with Satiety, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Satiety
- What is being tested?
- Experimental dietary protein, Casein and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jul 2019to 5 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centre for Nutrition Research, University of Navarra
Pamplona, Navarre, 31008
About this study
Official title: Effect of a Protein Intake on the Feeling of Hunger / Satiety in Men and Women Through an Acute Postprandial Study
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.
Read more
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.
Read the 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.
- Conditions
- Satiety
- Being tested
- Experimental dietary protein, Casein, Water
- Keywords
- Satiety, Hunger, Obesity, Ghrelin, Visual Analogue Scale, Gastrointestinal hormones, Energy compensation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental dietary proteinDietary supplement
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.
CaseinDietary supplement
Breakfast intake consisted on a 250 g custard intake mixed with 20 g of casein accompanied by a glass with 50 mL water.
WaterDietary supplement
Breakfast intake consisted on a 250 g custard intake mixed with 20 g of water accompanied by a glass with 50 mL water.
| Study group | Role | What they receive |
|---|---|---|
| Dietary protein | Experimental | Postprandial effects after consuming 20 g of a experimental dietary protein mixed with 250 g of custard and to drink of 50 mL of water served in a glass. Receives: Dietary Supplement: Experimental dietary protein |
| Casein | Active comparator | Postprandial effects after consuming 20 g of casein mixed with 250 g of custard and to drink of 50 mL of water served in a glass. Receives: Dietary Supplement: Casein |
| Water | Placebo comparator | Postprandial effects after consuming 20 g of water mixed with 250 g of custard and to drink of 50 mL of water served in a glass. Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Up to 90 minutes
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.
Measured: Baseline
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.
Measured: Up to 90 minutes
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.
Measured: Baseline
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.
Measured: Up to 90 minutes
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.
Measured: Baseline
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.
Measured: Up to 90 minutes
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.
Measured: Baseline
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.
Measured: Up to 90 minutes
Baseline blood ghrelin concentration
Blood ghrelin concentration before experimental custard intake.
Measured: Baseline
Postprandial blood ghrelin concentration
Blood ghrelin concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Measured: Up to 90 minutes
Ad libitum food intake
Quantification of food intake after the 90 minutes of postprandial period.
Measured: 90 minutes
Secondary outcomes (36)
Baseline weight
Baseline weight of participants will be reported in kg and will be performed in the first visit.
Measured: Baseline
Baseline height
Baseline height of participants will be reported in cm and will be performed in the first visit.
Measured: Baseline
Baseline body mass index
To calculate baseline body mass index weight and height will be combined to report BMI in kg/m^2
Measured: Baseline
Baseline waist circumference
Baseline waist circumference will be reported in cm and will be performed in the first visit
Measured: Baseline
Baseline systolic blood pressure
Baseline systolic blood pressure will be reported in mmHg at each visit
Measured: Baseline
Baseline diastolic blood pressure
Baseline diastolic blood pressure will be reported in mmHg at each visit
Measured: Baseline
Baseline heart rate
Baseline heart rate will be reported in beat/minute at each visit
Measured: Baseline
Baseline blood glucose concentration
Blood glucose levels before experimental custard intake
Measured: Baseline
Postprandial blood glucose concentration
Blood glucose measured at 15, 30, 60 and 90 minutes after experimental custard intake.
Measured: Up to 90 minutes
Baseline blood insulin concentration
Blood insulin levels before experimental custard intake
Measured: Baseline
Postprandial blood insulin concentration
Blood insulin measured at 15, 30, 60 and 90 minutes after experimental custard intake.
Measured: Up to 90 minutes
Baseline insulin resistance index (HOMA)
Insulin resistance index (HOMA) before experimental custard intake
Measured: Baseline
Postprandial insulin resistance index (HOMA)
Insulin resistance index (HOMA) at 15, 30, 60 and 90 minutes after experimental custard intake.
Measured: Up to 90 minutes
Baseline blood total cholesterol concentration
Blood total cholesterol concentration before experimental custard intake
Measured: Baseline
Postprandial blood total cholesterol concentration
Blood total cholesterol concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Measured: Up to 90 minutes
Baseline blood high density lipoprotein cholesterol (HDL) concentration
Blood high density lipoprotein cholesterol (HDL) concentration before experimental custard intake
Measured: Baseline
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.
Measured: Up to 90 minutes
Baseline blood low density lipoprotein cholesterol (LDL) concentration
Blood low density lipoprotein cholesterol (LDL) concentration before experimental custard intake
Measured: Baseline
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
Measured: Up to 90 minutes
Baseline blood triglyceride concentration
Blood triglyceride concentration before experimental custard intake
Measured: Baseline
Postprandial blood triglyceride concentration
Blood triglyceride concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Measured: Up to 90 minutes
Baseline blood cholecystokinin (CCK) concentration
Blood cholecystokinin (CCK) concentration before experimental custard intake
Measured: Baseline
Postprandial blood cholecystokinin (CCK) concentration
Blood cholecystokinin (CCK) concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Measured: Up to 90 minutes
Baseline blood glucagon like peptide-1 concentration
Blood glucagon like peptide-1 concentration concentration before experimental custard intake
Measured: Baseline
Postprandial blood glucagon like peptide-1 concentration
Blood glucagon like peptide-1 concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Measured: Up to 90 minutes
Baseline blood peptide YY (PYY) concentration
Blood peptide YY (PYY) concentration before experimental custard intake
Measured: Baseline
Postprandial blood peptide YY (PYY) concentration
Blood peptide YY (PYY) concentration at 15, 30, 60 and 90 minutes after experimental
Measured: Up to 90 minutes
Questionnaire about gastrointestinal symptoms (1)
Gastrointestinal questionnaire at 90 minutes of consuming the experimental custard.
Measured: 90 minutes
Questionnaire about gastrointestinal symptoms (2)
Gastrointestinal questionnaire before dinner of the experimental day.
Measured: Before dinner of the experimental day
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.
Measured: During the whole day of the experimental day.
Baseline blood apolipoprotein concentration
Blood apolipoproteins concentration before experimental custard intake
Measured: Baseline
Postprandial blood apolipoprotein concentration
Blood apolipoprotein concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Measured: Up to 90 minutes
Baseline blood concentration of reference amino acid of the experimental protein.
Baseline blood concentration of reference amino acids of the experimental protein.
Measured: Baseline
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.
Measured: Up to 90 minutes
Baseline urine concentration of reference amino acid of the experimental protein.
Baseline urine concentration of reference amino acid of the experimental protein.
Measured: Baseline
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
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start17 Jul 2019
- Primary completion5 Dec 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marian Zulet, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- M Ángeles Zulet Alzórriz, Professor, Principal investigator, Centre for Nutrition Research - University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210544
- Sponsor's protocol ID
- 2019.069
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Protein Intake on the Feeling of Hunger / Satiety in Men and Women Through an Acute Postprandial Study
- ClinicalTrials.gov ID
- NCT04210544
- Acronym / sponsor ID
- 2019.069
- Conditions
- Satiety
- Keywords
- Satiety, Hunger, Obesity, Ghrelin, Visual Analogue Scale, Gastrointestinal hormones, Energy compensation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary protein | Experimental | Dietary Supplement: Experimental dietary proteinPostprandial effects after consuming 20 g of a experimental dietary protein mixed with 250 g of custard and to drink of 50 mL of water served in a glass. |
| Casein | Active comparator | Dietary Supplement: CaseinPostprandial effects after consuming 20 g of casein mixed with 250 g of custard and to drink of 50 mL of water served in a glass. |
| Water | Placebo comparator | Dietary Supplement: WaterPostprandial effects after consuming 20 g of water mixed with 250 g of custard and to drink of 50 mL of water served in a glass. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental dietary proteinBreakfast 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 supplement | Dietary protein |
| CaseinBreakfast intake consisted on a 250 g custard intake mixed with 20 g of casein accompanied by a glass with 50 mL water. | Dietary supplement | Casein |
| WaterBreakfast intake consisted on a 250 g custard intake mixed with 20 g of water accompanied by a glass with 50 mL water. | Dietary supplement | Water |
Primary outcome
Baseline subjective hunger
Time frame: Baseline
Visual analogue scale rating in a scale from 0 to 100 mm, for the quantification the perceived hunger before the experimental custard intake.
Postprandial subjective hunger
Time frame: Up to 90 minutes
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.
Baseline subjective fullness
Time frame: Baseline
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived fullness before experimental custard intake.
Postprandial subjective fullness
Time frame: Up to 90 minutes
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.
Baseline subjective satiety
Time frame: Baseline
Visual analogue scale rating in a scale from 0 to100 mm for the quantification of the perceived fullness before experimental custard intake.
Postprandial subjective satiety
Time frame: Up to 90 minutes
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.
Baseline subjective desire to eat
Time frame: Baseline
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.
Postprandial subjective desire to eat
Time frame: Up to 90 minutes
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.
Baseline subjective thirst
Time frame: Baseline
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived fullness before experimental custard intake.
Postprandial subjective thirst
Time frame: Up to 90 minutes
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.
Baseline blood ghrelin concentration
Time frame: Baseline
Blood ghrelin concentration before experimental custard intake.
Postprandial blood ghrelin concentration
Time frame: Up to 90 minutes
Blood ghrelin concentration at 15, 30, 60 and 90 minutes after experimental custard intake.
Ad libitum food intake
Time frame: 90 minutes
Quantification of food intake after the 90 minutes of postprandial period.
36 secondary outcomes
Baseline weight
Time frame: Baseline
Baseline height
Time frame: Baseline
Baseline body mass index
Time frame: Baseline
Baseline waist circumference
Time frame: Baseline
Baseline systolic blood pressure
Time frame: Baseline
Baseline diastolic blood pressure
Time frame: Baseline
Baseline heart rate
Time frame: Baseline
Baseline blood glucose concentration
Time frame: Baseline
Postprandial blood glucose concentration
Time frame: Up to 90 minutes
Baseline blood insulin concentration
Time frame: Baseline
Postprandial blood insulin concentration
Time frame: Up to 90 minutes
Baseline insulin resistance index (HOMA)
Time frame: Baseline
Postprandial insulin resistance index (HOMA)
Time frame: Up to 90 minutes
Baseline blood total cholesterol concentration
Time frame: Baseline
Postprandial blood total cholesterol concentration
Time frame: Up to 90 minutes
Baseline blood high density lipoprotein cholesterol (HDL) concentration
Time frame: Baseline
Postprandial blood high density lipoprotein cholesterol (HDL) concentration
Time frame: Up to 90 minutes
Baseline blood low density lipoprotein cholesterol (LDL) concentration
Time frame: Baseline
Postprandial blood low density lipoprotein cholesterol (LDL) cholesterol concentration
Time frame: Up to 90 minutes
Baseline blood triglyceride concentration
Time frame: Baseline
Postprandial blood triglyceride concentration
Time frame: Up to 90 minutes
Baseline blood cholecystokinin (CCK) concentration
Time frame: Baseline
Postprandial blood cholecystokinin (CCK) concentration
Time frame: Up to 90 minutes
Baseline blood glucagon like peptide-1 concentration
Time frame: Baseline
Postprandial blood glucagon like peptide-1 concentration
Time frame: Up to 90 minutes
Baseline blood peptide YY (PYY) concentration
Time frame: Baseline
Postprandial blood peptide YY (PYY) concentration
Time frame: Up to 90 minutes
Questionnaire about gastrointestinal symptoms (1)
Time frame: 90 minutes
Questionnaire about gastrointestinal symptoms (2)
Time frame: Before dinner of the experimental day
Quantification of food intake during the rest of the day
Time frame: During the whole day of the experimental day.
Baseline blood apolipoprotein concentration
Time frame: Baseline
Postprandial blood apolipoprotein concentration
Time frame: Up to 90 minutes
Baseline blood concentration of reference amino acid of the experimental protein.
Time frame: Baseline
Postprandial blood concentration of reference amino acid of the experimental protein
Time frame: Up to 90 minutes
Baseline urine concentration of reference amino acid of the experimental protein.
Time frame: Baseline
Urine concentration of reference amino acid of the experimental protein at 90 minutes post ingestion
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M Ángeles Zulet Alzórriz, Professor principal investigator
Centre for Nutrition Research - University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental dietary protein, Casein and Water in people with Satiety, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline subjective hunger (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.