Status:
COMPLETED
Meat Derivative and Satiating Compound Effect on Satiety
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Collaborating Sponsors:
Creaciones Aromáticas Industriales, S.A. (CARINSA)
Conditions:
Overweight
Eligibility:
All Genders
18-65 years
Phase:
NA
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 heal...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04088812
Start Date
October 11 2019
End Date
January 25 2020
Last Update
March 4 2020
Active Locations (1)
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1
Institute for Health Research IdiPAZ
Madrid, Spain, 28046