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Meat Derivative and Satiating Compound Effect on Satiety (SACIMEAT)

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ClinicalTrials.gov Identifier: NCT04088812
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Creaciones Aromáticas Industriales, S.A. (CARINSA)
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

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).

Condition or disease Intervention/treatment Phase
Overweight Other: Placebo meat derivative + Placebo satiating compound Other: Placebo meat derivative + Satiating compound Other: Experimental meat derivative + Placebo satiating control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Interventional Trial to Evaluate a Meat Derivative Product and a Satiating Compound on Satiety in a Group of Healthy Overweight Subjects
Estimated Study Start Date : October 11, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : January 31, 2020

Arm Intervention/treatment
Placebo Comparator: Placebo meat derivative + Placebo satiating compound
60 g Placebo meat derivative 25 g Placebo satiating compound
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

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

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

Experimental: Placebo meat derivative + Satiating compound
60 g Placebo meat derivative 25 g Satiating compound
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

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

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

Experimental: Experimental meat derivative + Placebo satiating control
60 g Experimental meat derivative 25 g Placebo satiating compound
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

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

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




Primary Outcome Measures :
  1. Change from Baseline Satiety Hunger Assessment [ Time Frame: Day 1-3 ]

    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 :
  1. Change from Baseline Blood Hormonal Satiety Markers [ Time Frame: Day 1-3 ]
    Glucagon-like peptide-1 (GLP-1), Peptide YY, Ghrelin, Leptin, Gastric Inhibitory Peptide (GIP), Peptide C

  2. Amount of food consumed in a "food ad libitum" [ Time Frame: Day 1-3 ]
    240 min After eating the study product

  3. Total amount of food consumed in 24h [ Time Frame: Day 1-3 ]
    24h Food Record Method

  4. Change from Baseline Glucose Metabolism Parameters [ Time Frame: Day 1-3 ]
    Glucose

  5. Anthropometric Parameters [ Time Frame: Day 1-3 ]
    Weight and height will be combined to report BMI in kg/m2

  6. Adverse Effects [ Time Frame: Day 1-3 ]
    Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   10 men and 10 women
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088812


Contacts
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Contact: Carmen Gómez Candela, MD, PhD +34917277413 ext 42199 cgcandela@salud.madrid.org

Locations
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Spain
Institute for Health Research IdiPAZ Recruiting
Madrid, Spain, 28046
Contact: Carmen Gómez Candela, MD, PhD    +34917277413 ext 42199      
Sub-Investigator: Cristina Santurino Fontecha, PhD         
Principal Investigator: Samara Palma Milla, MD, PhD         
Principal Investigator: Bricia López Plaza, PhD         
Sub-Investigator: Marina Morato Martínez, PhD         
Sub-Investigator: Marlhyn Valero Pérez, PhD         
Sub-Investigator: Lucia Arcos Castellanos, BSc         
Sub-Investigator: Edwin Fernandez Cruz, PhD         
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Creaciones Aromáticas Industriales, S.A. (CARINSA)
Investigators
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Principal Investigator: Bricia López Plaza, PhD La Paz University Hospital

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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT04088812     History of Changes
Other Study ID Numbers: HULP 5389
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Satiety
Meat derivative
Fiber
Visual Analogue Scale
Parallel
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms