- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04345029
Effectiveness of a Natural Ingredient on Appetite Regulation (SAC)
Randomized Controlled Trial of Efficacy of a Natural Ingredient on Appetite Regulation in Overweight / Obese Patients Grade I
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Murcia, Spain, 30107
- Catholic University of Murcia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental group (Lippia citriodora + sabdariffa)
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. |
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. |
PLACEBO_COMPARATOR: control group Placebo (sucrose)
Two capsules per day will be consumed thirty minutes before breakfast orally for 60 days.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 (%)
|
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
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 (%)
|
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
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 (%)
|
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
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 (%)
|
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
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 (%)
|
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.
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 (%)
|
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
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 (%)
|
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
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 (%)
|
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
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
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It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
|
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
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It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Hormonal analysis, measured in mU/L
|
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.
|
Hormonal analysis, measured in ng/dL
|
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.
|
Hormonal analysis, measured in µg/mL
|
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.
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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.
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Hormonal analysis, measured in ng/ml
|
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.
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Hormonal analysis, measured in pg/mL
|
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.
|
Hormonal analysis, measured in ng/mL
|
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.
|
Glycidic analysis, measured in mg/dL
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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.
|
Glycidic analysis, measured in %
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It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
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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.
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Glycidic analysis
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It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
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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.
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Lipidic profile, measured in mg/dl
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It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
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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.
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Lipidic profile, measured in mg/dl
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It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
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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.
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Lipidic profile, measured in mg/dl
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It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
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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.
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Lipidic profile, measured in mg/dl
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It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
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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.
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Bioimpedance, in Kg.
For this we will use a TANITA
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It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
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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.
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Bioimpedance, in Kg.
For this we will use a TANITA
|
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.
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Bioimpedance, in Kg/m2.
For this we will use a TANITA
|
It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
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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.
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Measured in MET, with Actigraph wGT3X-BT
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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.
|
GIQLI
|
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.
|
WHOQOL BREF
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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.
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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)
|
It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
|
Collaborators and Investigators
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
- UCAMCFE-00012
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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