Protein Intake and Satiety: a Postprandial Study

NCT04210544 | Completed

• 1 other identifier: 2019.069
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Satiety

Keywords

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

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Baseline blood ghrelin concentration

  Blood ghrelin concentration before experimental custard intake.

  Baseline

• Postprandial blood ghrelin concentration

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

  Up to 90 minutes

• Ad libitum food intake

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

  90 minutes

Secondary Outcomes (36)

• Baseline weight

  Baseline

• Baseline height

  Baseline

• Baseline body mass index

  Baseline

• Baseline waist circumference

  Baseline

• Baseline systolic blood pressure

  Baseline

Study Arms (3)

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.

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.

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.

Dietary Supplement: Water

Interventions

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.

Dietary protein

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.

Casein

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.

Water

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Centre for Nutrition Research, University of Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Obesity

Interventions

Caseins; Water

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• M Ángeles Zulet Alzórriz, Professor

  Centre for Nutrition Research - University of Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 24, 2019
• Study Start: July 17, 2019
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)