NCT04210544

Protein Intake and Satiety: a Postprandial Study

Completed NA Last updated 24 December 2019

What this trial tests

NA trial testing Experimental dietary protein in Satiety in 48 participants. Completed in 5 December 2019.

Timeline

17 July 2019

Primary endpoint
5 December 2019

5 December 2019

Quick facts

Lead sponsor	Clinica Universidad de Navarra, Universidad de Navarra
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	48
Start date	17 July 2019
Primary completion	5 December 2019
Estimated completion	5 December 2019
Sites	1 location across Spain

Drugs / interventions tested

• Experimental dietary protein
• Casein
• Water (WATER) — full drug profile →

Conditions studied

• Satiety — all drugs for Satiety →

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Who can join

Adults 20 to 65, any sex, with Satiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.