- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04088812
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain, 28046
- Institute for Health Research IdiPAZ
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Investigators
- Principal Investigator: Bricia López Plaza, PhD, La Paz University Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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