Clinical trial NCT04088812: Meat Derivative and Satiating Compound Effect on Satiety
Official title: Interventional Trial to Evaluate a Meat Derivative Product and a Satiating Compound on Satiety in a Group of Healthy Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Satiety
Meat derivative
Fiber
Visual Analogue Scale
Parallel
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Creaciones Aromáticas Industriales, S.A. (CARINSA)
First posted: 2019-09-13
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the satiating effects of a meat derivative and a satiating compound on overweight subjects (BMI ≥25 and \<30 kg / m2).

Detailed description: A randomized, parallel, controlled and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of a meat derivate and a satiating compound in a group of healthy overweight subjects.

The investigators included 20 participants between 18 and 65 years (BMI ≥25 and \<30 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 2 study products during the 3 experimental phases.

Eligibility criteria: Inclusion Criteria:

* Men and women from 18 to 65 years old.
* Body Mass Index (BMI) ≥25 and \<30 kg/m2.
* Adequate cultural level and understanding for the clinical trial.
* Subjects willing to consume all food present in the brunch type meal.
* Signed informed consent.

Exclusion Criteria:

* Subjects with BMI ≥30 or \<25 kg /m2. Subjects with a vegetarian diet or with a great fiber consumption (\> 30 g/day)
* Subjects diagnosed with Diabetes Mellitus.
* Subjects with dyslipidemia on pharmacological treatment.
* Subjects with hypertension on pharmacological treatment.
* Subjects with hyper/hypothyroidism.
* Subjects with established diagnosis of eating disorder.
* Smokers or those subjects with high alcohol consumption (\> 2-3 servings/day in men and\> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer).
* Subjects under pharmacological treatment (except oral contraceptives).
* Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet.
* Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients.
* Subjects with severe chronic diseases (hepatic, kidney, ...)
* Subjects with intense physical activity.
* Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption.
* Subjects with a diagnosis of celiac disease or a gluten intolerance.
* Subjects who consume regularly oral supplements (i.e. omega-3)
* Pregnant or breastfeeding women.
* Women with menstrual irregularities (absence of menstrual cycle at least 2 months).

Primary outcomes:
measure: Change from Baseline Satiety Hunger Assessment
timeFrame: 0 min to 240 min
Secondary outcomes:
measure: Change from Baseline Blood Hormonal Satiety Markers
timeFrame: 0 min to 240 min
measure: Amount of food consumed in a "food ad libitum"
timeFrame: 240 min
measure: Total amount of food consumed in 24h
timeFrame: 24 hours
measure: Change from Baseline Glucose Metabolism Parameters
timeFrame: 0 min to 240 min
measure: Anthropometric Parameters
timeFrame: 24 hours
measure: Adverse Effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute for Health Research IdiPAZ
Study officials:
affiliation: La Paz University Hospital
name: Bricia López Plaza, PhD
role: PRINCIPAL_INVESTIGATOR
References: