search
Back to results

Meat Derivative and Satiating Compound Effect on Satiety (SACIMEAT)

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Placebo meat derivative + Placebo satiating compound
Placebo meat derivative + Satiating compound
Experimental meat derivative + Placebo satiating control
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight focused on measuring Satiety, Meat derivative, Fiber, Visual Analogue Scale, Parallel

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

  • Institute for Health Research IdiPAZ

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo meat derivative + Placebo satiating compound

Placebo meat derivative + Satiating compound

Experimental meat derivative + Placebo satiating control

Arm Description

60 g Placebo meat derivative 25 g Placebo satiating compound

60 g Placebo meat derivative 25 g Satiating compound

60 g Experimental meat derivative 25 g Placebo satiating compound

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2019
Last Updated
March 3, 2020
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Creaciones Aromáticas Industriales, S.A. (CARINSA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04088812
Brief Title
Meat Derivative and Satiating Compound Effect on Satiety
Acronym
SACIMEAT
Official Title
Interventional Trial to Evaluate a Meat Derivative Product and a Satiating Compound on Satiety in a Group of Healthy Overweight Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 11, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
January 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Creaciones Aromáticas Industriales, S.A. (CARINSA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Satiety, Meat derivative, Fiber, Visual Analogue Scale, Parallel

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo meat derivative + Placebo satiating compound
Arm Type
Placebo Comparator
Arm Description
60 g Placebo meat derivative 25 g Placebo satiating compound
Arm Title
Placebo meat derivative + Satiating compound
Arm Type
Experimental
Arm Description
60 g Placebo meat derivative 25 g Satiating compound
Arm Title
Experimental meat derivative + Placebo satiating control
Arm Type
Experimental
Arm Description
60 g Experimental meat derivative 25 g Placebo satiating compound
Intervention Type
Other
Intervention Name(s)
Placebo meat derivative + Placebo satiating compound
Intervention Description
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
Intervention Name(s)
Placebo meat derivative + Satiating compound
Intervention Description
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
Intervention Name(s)
Experimental meat derivative + Placebo satiating control
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline Satiety Hunger Assessment
Description
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.
Time Frame
0 min to 240 min
Secondary Outcome Measure Information:
Title
Change from Baseline Blood Hormonal Satiety Markers
Description
Glucagon-like peptide-1 (GLP-1), Peptide tyrosine-tyrosine (YY), Ghrelin, Leptin, Gastric Inhibitory Peptide (GIP), Peptide C
Time Frame
0 min to 240 min
Title
Amount of food consumed in a "food ad libitum"
Description
240 min After eating the study product
Time Frame
240 min
Title
Total amount of food consumed in 24h
Description
24h Food Record Method
Time Frame
24 hours
Title
Change from Baseline Glucose Metabolism Parameters
Description
Concentration of Glucose
Time Frame
0 min to 240 min
Title
Anthropometric Parameters
Description
Weight and height will be combined to report BMI in kg/m2
Time Frame
24 hours
Title
Adverse Effects
Description
Number of participants with gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)
Time Frame
24 hours

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
10 men and 10 women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bricia López Plaza, PhD
Organizational Affiliation
La Paz University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Health Research IdiPAZ
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Meat Derivative and Satiating Compound Effect on Satiety

We'll reach out to this number within 24 hrs