Meat Derivative and Satiating Compound Effect on Satiety (SACIMEAT)

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Overweight

Treatments: Other: Placebo meat derivative + Satiating compound; Other: Experimental meat derivative + Placebo satiating control; Other: Placebo meat derivative + Placebo satiating compound

Study type: Interventional

Funder types: Other

Identifiers

NCT04088812

HULP 5389

Details and patient eligibility

About

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).

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 3 patient groups, including a placebo group

Placebo meat derivative + Placebo satiating compound

Placebo Comparator group

Description:

60 g Placebo meat derivative 25 g Placebo satiating compound

Treatment:

Other: Experimental meat derivative + Placebo satiating control

Other: Placebo meat derivative + Placebo satiating compound

Other: Placebo meat derivative + Satiating compound

Placebo meat derivative + Satiating compound

Experimental group

Description:

60 g Placebo meat derivative 25 g Satiating compound

Treatment:

Other: Experimental meat derivative + Placebo satiating control

Other: Placebo meat derivative + Placebo satiating compound

Other: Placebo meat derivative + Satiating compound

Experimental meat derivative + Placebo satiating control

Experimental group

Description:

60 g Experimental meat derivative 25 g Placebo satiating compound

Treatment:

Other: Experimental meat derivative + Placebo satiating control

Other: Placebo meat derivative + Placebo satiating compound

Other: Placebo meat derivative + Satiating compound