Meat Derivative and Satiating Compound Effect on Satiety (SACIMEAT)

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

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).

Study Overview

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain, 28046
        • Institute for Health Research IdiPAZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo meat derivative + Placebo satiating compound
60 g Placebo meat derivative 25 g 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
Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water
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: Placebo meat derivative + Satiating compound
60 g Placebo meat derivative 25 g 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
Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water
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: Experimental meat derivative + Placebo satiating control
60 g Experimental meat derivative 25 g 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
Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

0 min to 240 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Blood Hormonal Satiety Markers
Time Frame: 0 min to 240 min
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"
Time Frame: 240 min
240 min After eating the study product
240 min
Total amount of food consumed in 24h
Time Frame: 24 hours
24h Food Record Method
24 hours
Change from Baseline Glucose Metabolism Parameters
Time Frame: 0 min to 240 min
Concentration of Glucose
0 min to 240 min
Anthropometric Parameters
Time Frame: 24 hours
Weight and height will be combined to report BMI in kg/m2
24 hours
Adverse Effects
Time Frame: 24 hours
Number of participants with gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bricia López Plaza, PhD, La Paz University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 11, 2019

Primary Completion (ACTUAL)

October 31, 2019

Study Completion (ACTUAL)

January 25, 2020

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

September 12, 2019

First Posted (ACTUAL)

September 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULP 5389

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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