Interventional Trial to Evaluate a Meat Derivative Product and a Satiating Compound on Satiety in a Group of Healthy Overweight Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Change from Baseline Satiety Hunger Assessment
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men and women from 18 to 65 years old.
- •Body Mass Index (BMI) ≥25 and <30 kg/m
- •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 /m
- •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).
Arms & Interventions
Placebo meat derivative + Placebo satiating compound
60 g Placebo meat derivative 25 g Placebo satiating compound
Intervention: Placebo meat derivative + Placebo satiating compound (Other)
Placebo meat derivative + Placebo satiating compound
60 g Placebo meat derivative 25 g Placebo satiating compound
Intervention: Placebo meat derivative + Satiating compound (Other)
Placebo meat derivative + Placebo satiating compound
60 g Placebo meat derivative 25 g Placebo satiating compound
Intervention: Experimental meat derivative + Placebo satiating control (Other)
Placebo meat derivative + Satiating compound
60 g Placebo meat derivative 25 g Satiating compound
Intervention: Placebo meat derivative + Placebo satiating compound (Other)
Placebo meat derivative + Satiating compound
60 g Placebo meat derivative 25 g Satiating compound
Intervention: Placebo meat derivative + Satiating compound (Other)
Placebo meat derivative + Satiating compound
60 g Placebo meat derivative 25 g Satiating compound
Intervention: Experimental meat derivative + Placebo satiating control (Other)
Experimental meat derivative + Placebo satiating control
60 g Experimental meat derivative 25 g Placebo satiating compound
Intervention: Placebo meat derivative + Placebo satiating compound (Other)
Experimental meat derivative + Placebo satiating control
60 g Experimental meat derivative 25 g Placebo satiating compound
Intervention: Placebo meat derivative + Satiating compound (Other)
Experimental meat derivative + Placebo satiating control
60 g Experimental meat derivative 25 g Placebo satiating compound
Intervention: Experimental meat derivative + Placebo satiating control (Other)
Outcomes
Primary Outcomes
Change from Baseline Satiety Hunger Assessment
Time Frame: 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 Outcomes
- Anthropometric Parameters(24 hours)
- Change from Baseline Glucose Metabolism Parameters(0 min to 240 min)
- Change from Baseline Blood Hormonal Satiety Markers(0 min to 240 min)
- Adverse Effects(24 hours)
- Amount of food consumed in a "food ad libitum"(240 min)
- Total amount of food consumed in 24h(24 hours)