Meat Derivative and Satiating Compound Effect on Satiety
- Conditions
- Overweight
- Interventions
- Other: Placebo meat derivative + Placebo satiating compoundOther: Placebo meat derivative + Satiating compoundOther: Experimental meat derivative + Placebo satiating control
- Registration Number
- NCT04088812
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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.
- 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
- Arm && Interventions
Group Intervention Description Placebo meat derivative + Satiating compound Placebo meat derivative + Satiating compound 60 g Placebo meat derivative 25 g Satiating compound Experimental meat derivative + Placebo satiating control Placebo meat derivative + Placebo satiating compound 60 g Experimental meat derivative 25 g Placebo satiating compound Placebo meat derivative + Placebo satiating compound Placebo meat derivative + Satiating compound 60 g Placebo meat derivative 25 g Placebo satiating compound Placebo meat derivative + Satiating compound Placebo meat derivative + Placebo satiating compound 60 g Placebo meat derivative 25 g Satiating compound Experimental meat derivative + Placebo satiating control Experimental meat derivative + Placebo satiating control 60 g Experimental meat derivative 25 g Placebo satiating compound Placebo meat derivative + Placebo satiating compound Placebo meat derivative + Placebo satiating compound 60 g Placebo meat derivative 25 g Placebo satiating compound Placebo meat derivative + Placebo satiating compound Experimental meat derivative + Placebo satiating control 60 g Placebo meat derivative 25 g Placebo satiating compound Placebo meat derivative + Satiating compound Experimental meat derivative + Placebo satiating control 60 g Placebo meat derivative 25 g Satiating compound Experimental meat derivative + Placebo satiating control Placebo meat derivative + Satiating compound 60 g Experimental meat derivative 25 g Placebo satiating compound
- 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