Meat Derivative and Satiating Compound Effect on Satiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-11

Study Completion Date

2020-01-25

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).

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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.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo meat derivative + Placebo satiating compound

60 g Placebo meat derivative 25 g Placebo satiating compound

Group Type PLACEBO_COMPARATOR

Placebo meat derivative + Placebo satiating compound

Intervention Type OTHER

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

Placebo meat derivative + Satiating compound

Intervention Type OTHER

Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water

Experimental meat derivative + Placebo satiating control

Intervention Type OTHER

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

Placebo meat derivative + Satiating compound

60 g Placebo meat derivative 25 g Satiating compound

Group Type EXPERIMENTAL

Placebo meat derivative + Placebo satiating compound

Intervention Type OTHER

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

Placebo meat derivative + Satiating compound

Intervention Type OTHER

Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water

Experimental meat derivative + Placebo satiating control

Intervention Type OTHER

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

Experimental meat derivative + Placebo satiating control

60 g Experimental meat derivative 25 g Placebo satiating compound

Group Type EXPERIMENTAL

Placebo meat derivative + Placebo satiating compound

Intervention Type OTHER

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

Placebo meat derivative + Satiating compound

Intervention Type OTHER

Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water

Experimental meat derivative + Placebo satiating control

Intervention Type OTHER

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

Interventions

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Placebo meat derivative + Placebo satiating compound

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

Intervention Type OTHER

Placebo meat derivative + Satiating compound

Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water

Intervention Type OTHER

Experimental meat derivative + Placebo satiating control

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

Intervention Type OTHER

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes