Meat Derivative and Satiating Compound Effect on Satiety

Overweight Clinical Trial

— SACIMEAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04088812
• Other study ID #: HULP 5389
• Status: Completed
• Phase: N/A
• Start date: October 11, 2019
• Est. completion date: January 25, 2020

Study information

• Verified date: February 2020
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 25, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• 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
• 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
• 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

Locations

Country	Name	City	State
Spain	Institute for Health Research IdiPAZ	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Creaciones Aromáticas Industriales, S.A. (CARINSA)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Amount of food consumed in a "food ad libitum"	240 min After eating the study product	240 min
Secondary	Total amount of food consumed in 24h	24h Food Record Method	24 hours
Secondary	Change from Baseline Glucose Metabolism Parameters	Concentration of Glucose	0 min to 240 min
Secondary	Anthropometric Parameters	Weight and height will be combined to report BMI in kg/m2	24 hours
Secondary	Adverse Effects	Number of participants with gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)	24 hours