Appetite RegulationSACNCT04345029
Effectiveness of a Natural Ingredient on Appetite Regulation
A study testing Dietary supplement consumption in people with Appetite Regulation and Overweight and Obesity, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Single-center, double-blind, double-crossed, randomized controlled clinical trial with two crossed branches, designed with the objective of evaluating the effect of the investigational product on satiety. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation, Overweight and Obesity
- What is being tested?
- Dietary supplement consumption
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2020to 30 Jun 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
- Age 18-65 years.
- Both genders.
- BMI 25-34.9 kg / m2, both inclusive.
- Weight maintained during the last 3 months.
- Smoking subjects or not, but in any case they do not change their nicotinic habits during their participation in the study.
- Absence of disease diagnosed at the start of the study.
Who cannot join
- Thyroid dysfunction, infections, or with any type of chronic disease (eg, autoimmune, inflammatory).
- History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- Subjects who are performing or intend to carry out any type of diet, low-calorie or not, during the study.
- Participation in another clinical trial in the three months prior to the study.
- Lack of will or inability to comply with clinical trial procedures.
- Pregnant woman.
- Subjects whose condition does not make them eligible for the study according to the researcher's criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Efficacy of a Natural Ingredient on Appetite Regulation in Overweight / Obese Patients Grade I
Single-center, double-blind, double-crossed, randomized controlled clinical trial with two crossed branches, designed with the objective of evaluating the effect of the investigational product on satiety.
Read the detailed description
Subjects who meet the selection criteria will make a total of five visits to the research laboratory and will carry out the tests established in the protocol. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.
- Conditions
- Appetite Regulation, Overweight and Obesity
- Being tested
- Dietary supplement consumption
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement consumptionDietary supplement
The experimental product consumption time was 60 days and the control consumption time was 60 days.
Each subject must consume both products, with a washing period of 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (Lippia citriodora + sabdariffa) | Experimental | Consumption for 60 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg.
Two capsules per day will be consumed thirty minutes before breakfast orally for 60 days. Receives: Dietary Supplement: Dietary supplement consumption |
| control group Placebo (sucrose) | Placebo comparator | Two capsules per day will be consumed thirty minutes before breakfast orally for 60 days. Receives: Dietary Supplement: Dietary supplement consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of appetite sensation
Satiety assessment, measured in eva scale (%)
Measured: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Sensation of appetite before intaking the product under investigation
Satiety assessment, measured in eva scale (%)
Measured: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Area under the curve of the evolution of the appetite sensation from instant zero ingestion to instant ingestion of 60 minutes
Satiety assessment, measured in eva scale (%)
Measured: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Average of the appetite sensation during the 60 minutes after intake of the experimented product
Satiety assessment, measured in eva scale (%)
Measured: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Decrease in the sensation of appetite suffering from subjects when consuming the product in experimentation
Satiety assessment, measured in eva scale (%)
Measured: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Area under the curve of the evolution of the appetite feeling from the 60 minutes post-intake instantly 240 minutes post-intake.
Satiety assessment, measured in eva scale (%)
Measured: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Appetite sensation at 240 minutes post-ingestion and area under the curve of the evolution of appetite feeling from instant zero post-intake to instant 240 minutes post-intake
Satiety assessment, measured in eva scale (%)
Measured: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Appetite feeling immediately after ad-libitum food
Satiety assessment, measured in eva scale (%)
Measured: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Amount of energy consumed during the ad-libitum meal
Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test
Measured: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety quotient (SQ)
Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test
Measured: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Secondary outcomes (20)
Insulinemia
Hormonal analysis, measured in mU/L
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Leptin
Hormonal analysis, measured in ng/dL
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Adiponectin
Hormonal analysis, measured in µg/mL
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Ghrelin (GHRL)
Hormonal analysis, measured in ng/ml
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Tyrosine Peptide Tyrosine (PYY)
Hormonal analysis, measured in pg/mL
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Glucagon Like Peptide - 1 (GLP-1)
Hormonal analysis, measured in ng/mL
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Blood glucose
Glycidic analysis, measured in mg/dL
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Glycosylated hemoglobin (HBA1c)
Glycidic analysis, measured in %
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Peripheral insulin resistance (HOMA-IR)
Glycidic analysis
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Total Cholesterol
Lipidic profile, measured in mg/dl
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
LDL - Cholesterol
Lipidic profile, measured in mg/dl
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
HDL - Cholesterol
Lipidic profile, measured in mg/dl
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Triglycerides
Lipidic profile, measured in mg/dl
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Fat mass
Bioimpedance, in Kg. For this we will use a TANITA
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Muscle mass
Bioimpedance, in Kg. For this we will use a TANITA
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Body mass index
Bioimpedance, in Kg/m2. For this we will use a TANITA
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Physical activity
Measured in MET, with Actigraph wGT3X-BT
Measured: It will be measured for 3 days before and after the consumption time (60 days) with the experimental product and the placebo product.
Gastrointestinal Quality of Life Test
GIQLI
Measured: It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.
Quality of Life Test
WHOQOL BREF
Measured: It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.
Liver safety variables
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start15 Jan 2020
- Primary completion15 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetite RegulationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345029
- Sponsor's protocol ID
- UCAMCFE-00012
- Acronym
- SAC
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 19 Oct 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Efficacy of a Natural Ingredient on Appetite Regulation in Overweight / Obese Patients Grade I
- ClinicalTrials.gov ID
- NCT04345029
- Acronym / sponsor ID
- SAC / UCAMCFE-00012
- Conditions
- Appetite Regulation, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 14 Apr 2020 (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.
Single-center, double-blind, double-crossed, randomized controlled clinical trial with two crossed branches, designed with the objective of evaluating the effect of the investigational product on satiety.
Detailed description
Subjects who meet the selection criteria will make a total of five visits to the research laboratory and will carry out the tests established in the protocol. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (Lippia citriodora + sabdariffa) | Experimental | Dietary Supplement: Dietary supplement consumptionConsumption for 60 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg. Two capsules per day will be consumed thirty minutes before breakfast orally for 60 days. |
| control group Placebo (sucrose) | Placebo comparator | Dietary Supplement: Dietary supplement consumptionTwo capsules per day will be consumed thirty minutes before breakfast orally for 60 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65 years.
- Both genders.
- BMI 25-34.9 kg / m2, both inclusive.
- Weight maintained during the last 3 months.
- Smoking subjects or not, but in any case they do not change their nicotinic habits during their participation in the study.
Key exclusion criteria (7 listed)
- Thyroid dysfunction, infections, or with any type of chronic disease (eg, autoimmune, inflammatory).
- History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- Subjects who are performing or intend to carry out any type of diet, low-calorie or not, during the study.
- Participation in another clinical trial in the three months prior to the study.
- Lack of will or inability to comply with clinical trial procedures.
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 |
|---|---|---|
| Dietary supplement consumptionThe experimental product consumption time was 60 days and the control consumption time was 60 days. Each subject must consume both products, with a washing period of 30 days. | Dietary supplement | Experimental group (Lippia citriodora + sabdariffa), control group Placebo (sucrose) |
Primary outcome
Evolution of appetite sensation
Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Sensation of appetite before intaking the product under investigation
Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Area under the curve of the evolution of the appetite sensation from instant zero ingestion to instant ingestion of 60 minutes
Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Average of the appetite sensation during the 60 minutes after intake of the experimented product
Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Decrease in the sensation of appetite suffering from subjects when consuming the product in experimentation
Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Area under the curve of the evolution of the appetite feeling from the 60 minutes post-intake instantly 240 minutes post-intake.
Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Appetite sensation at 240 minutes post-ingestion and area under the curve of the evolution of appetite feeling from instant zero post-intake to instant 240 minutes post-intake
Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Appetite feeling immediately after ad-libitum food
Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in eva scale (%)
Amount of energy consumed during the ad-libitum meal
Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test
Satiety quotient (SQ)
Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test
20 secondary outcomes
Insulinemia
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Leptin
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Adiponectin
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Ghrelin (GHRL)
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Tyrosine Peptide Tyrosine (PYY)
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Glucagon Like Peptide - 1 (GLP-1)
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Blood glucose
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Glycosylated hemoglobin (HBA1c)
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Peripheral insulin resistance (HOMA-IR)
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Total Cholesterol
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
LDL - Cholesterol
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
HDL - Cholesterol
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Triglycerides
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Fat mass
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Muscle mass
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Body mass index
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Physical activity
Time frame: It will be measured for 3 days before and after the consumption time (60 days) with the experimental product and the placebo product.
Gastrointestinal Quality of Life Test
Time frame: It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.
Quality of Life Test
Time frame: It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.
Liver safety variables
Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
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 19 Oct 2020.
Related trials for Appetite Regulation
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Active, not recruiting
A Study to Evaluate the Effects of a Dietary Supplement on Weight Management and Appetite Control
Overweight, Obesity
Recruiting
GLycaemic Outcomes With Whey Protein in ageING
Type 2 Diabetes, Appetite Regulation
Recruiting
Eating to Adjust the Timing System
Dietary Intervention
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
Healthy Participants, Healthy Adult Subject
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement consumption in people with Appetite Regulation and Overweight and Obesity, run by Universidad Católica San Antonio de Murcia 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 6 inclusion and 7 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 19 Oct 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?
Evolution of appetite sensation (time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)). The study lists 10 primary outcomes in all. 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 19 Oct 2020.