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NCT Number: NCT04210544

Protein Intake and Satiety: a 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.

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.

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Key information

Conditions

Satiety Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Nutrition Research, University of Navarra

Pamplona, Navarre, 31008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Experimental dietary protein

Dietary 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.

Casein

Dietary Supplement

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

Water

Dietary Supplement

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Baseline blood ghrelin concentration

    Time frame: Baseline

    Blood ghrelin concentration before experimental custard intake.

  12. Postprandial blood ghrelin concentration

    Time frame: Up to 90 minutes

    Blood ghrelin concentration at 15, 30, 60 and 90 minutes after experimental custard intake.

  13. Ad libitum food intake

    Time frame: 90 minutes

    Quantification of food intake after the 90 minutes of postprandial period.

Secondary outcomes

  1. Baseline weight

    Time frame: Baseline

    Baseline weight of participants will be reported in kg and will be performed in the first visit.

  2. Baseline height

    Time frame: Baseline

    Baseline height of participants will be reported in cm and will be performed in the first visit.

  3. Baseline body mass index

    Time frame: Baseline

    To calculate baseline body mass index weight and height will be combined to report BMI in kg/m^2

  4. Baseline waist circumference

    Time frame: Baseline

    Baseline waist circumference will be reported in cm and will be performed in the first visit

  5. Baseline systolic blood pressure

    Time frame: Baseline

    Baseline systolic blood pressure will be reported in mmHg at each visit

  6. Baseline diastolic blood pressure

    Time frame: Baseline

    Baseline diastolic blood pressure will be reported in mmHg at each visit

  7. Baseline heart rate

    Time frame: Baseline

    Baseline heart rate will be reported in beat/minute at each visit

  8. Baseline blood glucose concentration

    Time frame: Baseline

    Blood glucose levels before experimental custard intake

  9. Postprandial blood glucose concentration

    Time frame: Up to 90 minutes

    Blood glucose measured at 15, 30, 60 and 90 minutes after experimental custard intake.

  10. Baseline blood insulin concentration

    Time frame: Baseline

    Blood insulin levels before experimental custard intake

  11. Postprandial blood insulin concentration

    Time frame: Up to 90 minutes

    Blood insulin measured at 15, 30, 60 and 90 minutes after experimental custard intake.

  12. Baseline insulin resistance index (HOMA)

    Time frame: Baseline

    Insulin resistance index (HOMA) before experimental custard intake

  13. Postprandial insulin resistance index (HOMA)

    Time frame: Up to 90 minutes

    Insulin resistance index (HOMA) at 15, 30, 60 and 90 minutes after experimental custard intake.

  14. Baseline blood total cholesterol concentration

    Time frame: Baseline

    Blood total cholesterol concentration before experimental custard intake

  15. Postprandial blood total cholesterol concentration

    Time frame: Up to 90 minutes

    Blood total cholesterol concentration at 15, 30, 60 and 90 minutes after experimental custard intake.

  16. Baseline blood high density lipoprotein cholesterol (HDL) concentration

    Time frame: Baseline

    Blood high density lipoprotein cholesterol (HDL) concentration before experimental custard intake

  17. Postprandial blood high density lipoprotein cholesterol (HDL) concentration

    Time frame: Up to 90 minutes

    Blood high density lipoprotein cholesterol (HDL) concentration at 15, 30, 60 and 90 minutes after consuming 250 g of the experimental custard.

  18. Baseline blood low density lipoprotein cholesterol (LDL) concentration

    Time frame: Baseline

    Blood low density lipoprotein cholesterol (LDL) concentration before experimental custard intake

  19. Postprandial blood low density lipoprotein cholesterol (LDL) cholesterol concentration

    Time frame: Up to 90 minutes

    Low density lipoprotein cholesterol (LDL) concentration at 15, 30, 60 and 90 minutes after experimental custard intake

  20. Baseline blood triglyceride concentration

    Time frame: Baseline

    Blood triglyceride concentration before experimental custard intake

  21. Postprandial blood triglyceride concentration

    Time frame: Up to 90 minutes

    Blood triglyceride concentration at 15, 30, 60 and 90 minutes after experimental custard intake.

  22. Baseline blood cholecystokinin (CCK) concentration

    Time frame: Baseline

    Blood cholecystokinin (CCK) concentration before experimental custard intake

  23. Postprandial blood cholecystokinin (CCK) concentration

    Time frame: Up to 90 minutes

    Blood cholecystokinin (CCK) concentration at 15, 30, 60 and 90 minutes after experimental custard intake.

  24. Baseline blood glucagon like peptide-1 concentration

    Time frame: Baseline

    Blood glucagon like peptide-1 concentration concentration before experimental custard intake

  25. Postprandial blood glucagon like peptide-1 concentration

    Time frame: Up to 90 minutes

    Blood glucagon like peptide-1 concentration at 15, 30, 60 and 90 minutes after experimental custard intake.

  26. Baseline blood peptide YY (PYY) concentration

    Time frame: Baseline

    Blood peptide YY (PYY) concentration before experimental custard intake

  27. Postprandial blood peptide YY (PYY) concentration

    Time frame: Up to 90 minutes

    Blood peptide YY (PYY) concentration at 15, 30, 60 and 90 minutes after experimental

  28. Questionnaire about gastrointestinal symptoms (1)

    Time frame: 90 minutes

    Gastrointestinal questionnaire at 90 minutes of consuming the experimental custard.

  29. Questionnaire about gastrointestinal symptoms (2)

    Time frame: Before dinner of the experimental day

    Gastrointestinal questionnaire before dinner of the experimental day.

  30. Quantification of food intake during the rest of the day

    Time frame: During the whole day of the experimental day.

    Food record calibration from the end of the ad libitum lunch until go to sleep.

  31. Baseline blood apolipoprotein concentration

    Time frame: Baseline

    Blood apolipoproteins concentration before experimental custard intake

  32. Postprandial blood apolipoprotein concentration

    Time frame: Up to 90 minutes

    Blood apolipoprotein concentration at 15, 30, 60 and 90 minutes after experimental custard intake.

  33. Baseline blood concentration of reference amino acid of the experimental protein.

    Time frame: Baseline

    Baseline blood concentration of reference amino acids of the experimental protein.

  34. Postprandial blood concentration of reference amino acid of the experimental protein

    Time frame: Up to 90 minutes

    Blood concentration (15, 30, 60 and 90 minutes) of reference amino acid of the experimental protein after the experimental custard intake.

  35. Baseline urine concentration of reference amino acid of the experimental protein.

    Time frame: Baseline

    Baseline urine concentration of reference amino acid of the experimental protein.

  36. Urine concentration of reference amino acid of the experimental protein at 90 minutes post ingestion

    Time frame: 90 minutes

    Urine concentration of reference amino acid of the experimental protein at 90 minutes post ingestion

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 24, 2019
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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