Meat Derivative and Satiating Compound Effect on Satiety

Not Applicable

Completed

• Conditions: Overweight

• Registration Number: NCT04088812
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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.

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-13
• Study Start: 2019-10-11
• Primary Completion: 2019-10-31
• Study Completion: 2020-01-25
• Status Verified: 2020-02
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline Satiety Hunger Assessment	0 min to 240 min	Visual Analogue Scale (VAS). 100 mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line.; e.g., "not at all hungry" (0mm) and "as hungry as I have ever felt" (100mm). Multiple measures are taken at repeated time intervals described below.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Glucose Metabolism Parameters	0 min to 240 min	Concentration of Glucose
Change from Baseline Blood Hormonal Satiety Markers	0 min to 240 min	Glucagon-like peptide-1 (GLP-1), Peptide tyrosine-tyrosine (YY), Ghrelin, Leptin, Gastric Inhibitory Peptide (GIP), Peptide C
Anthropometric Parameters	24 hours	Weight and height will be combined to report BMI in kg/m2
Adverse Effects	24 hours	Number of participants with gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)
Amount of food consumed in a "food ad libitum"	240 min	240 min After eating the study product
Total amount of food consumed in 24h	24 hours	24h Food Record Method

Trial Locations

Locations (1)

Institute for Health Research IdiPAZ; 🇪🇸 Madrid, Spain