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Completed

NCT Number: NCT04088812

Meat Derivative and Satiating Compound Effect on Satiety

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).

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Placebo meat derivative + Placebo satiating compound

Other

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

Other

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

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Amount of food consumed in a "food ad libitum"

    Time frame: 240 min

    240 min After eating the study product

  3. Total amount of food consumed in 24h

    Time frame: 24 hours

    24h Food Record Method

  4. Change from Baseline Glucose Metabolism Parameters

    Time frame: 0 min to 240 min

    Concentration of Glucose

  5. Anthropometric Parameters

    Time frame: 24 hours

    Weight and height will be combined to report BMI in kg/m2

  6. Adverse Effects

    Time frame: 24 hours

    Number of participants with gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Collaborators

  • Creaciones Aromáticas Industriales, S.A. (CARINSA)

Registry information

Official study title

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

Acronym: SACIMEAT

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 13, 2019
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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