Meat Derivative and Satiating Compound Effect on Satiety

Study Overview
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Brief Summary
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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
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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.

Official Title
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Interventional Trial to Evaluate a Meat Derivative Product and a Satiating Compound on Satiety in a Group of Healthy Overweight Subjects

Conditions
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Overweight

Intervention / Treatment
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* Other: Placebo meat derivative + Placebo satiating compound
* Other: Placebo meat derivative + Satiating compound
* Other: Experimental meat derivative + Placebo satiating control


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo meat derivative + Placebo satiating compound<br>60 g Placebo meat derivative 25 g Placebo satiating compound | Other: Placebo meat derivative + Placebo satiating compound<br>* Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound placebo diluted in water<br>Other: Placebo meat derivative + Satiating compound<br>* Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water<br>Other: Experimental meat derivative + Placebo satiating control<br>* Subjects will consume 60 g of the experimental meat derivative in a brunch type meal with 25 g of satiating compound placebo diluted in water<br>|
| Experimental: Placebo meat derivative + Satiating compound<br>60 g Placebo meat derivative 25 g Satiating compound | Other: Placebo meat derivative + Placebo satiating compound<br>* Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound placebo diluted in water<br>Other: Placebo meat derivative + Satiating compound<br>* Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water<br>Other: Experimental meat derivative + Placebo satiating control<br>* Subjects will consume 60 g of the experimental meat derivative in a brunch type meal with 25 g of satiating compound placebo diluted in water<br>|
| Experimental: Experimental meat derivative + Placebo satiating control<br>60 g Experimental meat derivative 25 g Placebo satiating compound | Other: Placebo meat derivative + Placebo satiating compound<br>* Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound placebo diluted in water<br>Other: Placebo meat derivative + Satiating compound<br>* Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water<br>Other: Experimental meat derivative + Placebo satiating control<br>* Subjects will consume 60 g of the experimental meat derivative in a brunch type meal with 25 g of satiating compound placebo diluted in water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Satiety Hunger Assessment | 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. | 0 min to 240 min | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Satiety, Meat derivative, Fiber, Visual Analogue Scale, Parallel