OverweightSACIMEATNCT04088812
Meat Derivative and Satiating Compound Effect on Satiety
A study of Overweight, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- 11 Oct 2019to 25 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Overweight
- Being tested
- Placebo meat derivative + Placebo satiating compound, Placebo meat derivative + Satiating compound, Experimental meat derivative + Placebo satiating control
- Keywords
- Satiety, Meat derivative, Fiber, Visual Analogue Scale, Parallel
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo meat derivative + Placebo satiating compoundOther
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 compoundOther
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 controlOther
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo meat derivative + Placebo satiating compound | Placebo comparator | 60 g Placebo meat derivative 25 g Placebo satiating compound Receives: Other: Placebo meat derivative + Placebo satiating compound; Other: Placebo meat derivative + Satiating compound; Other: Experimental meat derivative + Placebo satiating control |
| Placebo meat derivative + Satiating compound | Experimental | 60 g Placebo meat derivative 25 g Satiating compound Receives: Other: Placebo meat derivative + Placebo satiating compound; Other: Placebo meat derivative + Satiating compound; Other: Experimental meat derivative + Placebo satiating control |
| Experimental meat derivative + Placebo satiating control | Experimental | 60 g Experimental meat derivative 25 g Placebo satiating compound Receives: Other: Placebo meat derivative + Placebo satiating compound; Other: Placebo meat derivative + Satiating compound; Other: Experimental meat derivative + Placebo satiating control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 min to 240 min
Secondary outcomes (6)
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
Measured: 0 min to 240 min
Amount of food consumed in a "food ad libitum"
240 min After eating the study product
Measured: 240 min
Total amount of food consumed in 24h
24h Food Record Method
Measured: 24 hours
Change from Baseline Glucose Metabolism Parameters
Concentration of Glucose
Measured: 0 min to 240 min
Anthropometric Parameters
Weight and height will be combined to report BMI in kg/m2
Measured: 24 hours
Adverse Effects
Number of participants with gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start11 Oct 2019
- Primary completion31 Oct 2019
- Study completion25 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Creaciones Aromáticas Industriales S.A.
- Responsible party
- Sponsor
- Investigators
- Bricia López Plaza, PhD, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088812
- Sponsor's protocol ID
- HULP 5389
- Acronym
- SACIMEAT
- Status last verified
- Feb 2020
- First submitted
- 9 Sep 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Trial to Evaluate a Meat Derivative Product and a Satiating Compound on Satiety in a Group of Healthy Overweight Subjects
- ClinicalTrials.gov ID
- NCT04088812
- Acronym / sponsor ID
- SACIMEAT / HULP 5389
- Conditions
- Overweight
- Keywords
- Satiety, Meat derivative, Fiber, Visual Analogue Scale, Parallel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Creaciones Aromáticas Industriales S.A.
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 25 Jan 2020 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo meat derivative + Placebo satiating compound | Placebo comparator | Other: Placebo meat derivative + Placebo satiating compound, Other: Placebo meat derivative + Satiating compound, Other: Experimental meat derivative + Placebo satiating control60 g Placebo meat derivative 25 g Placebo satiating compound |
| Placebo meat derivative + Satiating compound | Experimental | Other: Placebo meat derivative + Placebo satiating compound, Other: Placebo meat derivative + Satiating compound, Other: Experimental meat derivative + Placebo satiating control60 g Placebo meat derivative 25 g Satiating compound |
| Experimental meat derivative + Placebo satiating control | Experimental | Other: Placebo meat derivative + Placebo satiating compound, Other: Placebo meat derivative + Satiating compound, Other: Experimental meat derivative + Placebo satiating control60 g Experimental meat derivative 25 g Placebo satiating compound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo meat derivative + Placebo satiating compoundSubjects 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 | Experimental meat derivative + Placebo satiating control, Placebo meat derivative + Placebo satiating compound, Placebo meat derivative + Satiating compound |
| Placebo meat derivative + Satiating compoundSubjects 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, Placebo meat derivative + Placebo satiating compound, Placebo meat derivative + Satiating compound |
| Experimental meat derivative + Placebo satiating controlSubjects will consume 60 g of the experimental meat derivative in a brunch type meal with 25 g of satiating compound placebo diluted in water | Other | Experimental meat derivative + Placebo satiating control, Placebo meat derivative + Placebo satiating compound, Placebo meat derivative + Satiating compound |
Primary outcome
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.
6 secondary outcomes
Change from Baseline Blood Hormonal Satiety Markers
Time frame: 0 min to 240 min
Amount of food consumed in a "food ad libitum"
Time frame: 240 min
Total amount of food consumed in 24h
Time frame: 24 hours
Change from Baseline Glucose Metabolism Parameters
Time frame: 0 min to 240 min
Anthropometric Parameters
Time frame: 24 hours
Adverse Effects
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bricia López Plaza, PhD principal investigator
La Paz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Overweight, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Satiety Hunger Assessment (time frame: 0 min to 240 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020; AzTrials last refreshed its copy on 30 Oct 2026.