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Effectiveness of a Natural Ingredient on Appetite Regulation (SAC)

Primary Purpose

Appetite Regulation, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dietary supplement consumption
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appetite Regulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Catholic University of Murcia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group (Lippia citriodora + sabdariffa)

control group Placebo (sucrose)

Arm Description

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.

Two capsules per day will be consumed thirty minutes before breakfast orally for 60 days.

Outcomes

Primary Outcome Measures

Evolution of appetite sensation
Satiety assessment, measured in eva scale (%)
Sensation of appetite before intaking the product under investigation
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
Satiety assessment, measured in eva scale (%)
Average of the appetite sensation during the 60 minutes after intake of the experimented product
Satiety assessment, measured in eva scale (%)
Decrease in the sensation of appetite suffering from subjects when consuming the product in experimentation
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.
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
Satiety assessment, measured in eva scale (%)
Appetite feeling immediately after ad-libitum food
Satiety assessment, measured in eva scale (%)
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
Satiety quotient (SQ)
Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test

Secondary Outcome Measures

Insulinemia
Hormonal analysis, measured in mU/L
Leptin
Hormonal analysis, measured in ng/dL
Adiponectin
Hormonal analysis, measured in µg/mL
Ghrelin (GHRL)
Hormonal analysis, measured in ng/ml
Tyrosine Peptide Tyrosine (PYY)
Hormonal analysis, measured in pg/mL
Glucagon Like Peptide - 1 (GLP-1)
Hormonal analysis, measured in ng/mL
Blood glucose
Glycidic analysis, measured in mg/dL
Glycosylated hemoglobin (HBA1c)
Glycidic analysis, measured in %
Peripheral insulin resistance (HOMA-IR)
Glycidic analysis
Total Cholesterol
Lipidic profile, measured in mg/dl
LDL - Cholesterol
Lipidic profile, measured in mg/dl
HDL - Cholesterol
Lipidic profile, measured in mg/dl
Triglycerides
Lipidic profile, measured in mg/dl
Fat mass
Bioimpedance, in Kg. For this we will use a TANITA
Muscle mass
Bioimpedance, in Kg. For this we will use a TANITA
Body mass index
Bioimpedance, in Kg/m2. For this we will use a TANITA
Physical activity
Measured in MET, with Actigraph wGT3X-BT
Gastrointestinal Quality of Life Test
GIQLI
Quality of Life Test
WHOQOL BREF
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)

Full Information

First Posted
April 6, 2020
Last Updated
October 16, 2020
Sponsor
Universidad Católica San Antonio de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT04345029
Brief Title
Effectiveness of a Natural Ingredient on Appetite Regulation
Acronym
SAC
Official Title
Randomized Controlled Trial of Efficacy of a Natural Ingredient on Appetite Regulation in Overweight / Obese Patients Grade I
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetite Regulation, Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group (Lippia citriodora + sabdariffa)
Arm Type
Experimental
Arm Description
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.
Arm Title
control group Placebo (sucrose)
Arm Type
Placebo Comparator
Arm Description
Two capsules per day will be consumed thirty minutes before breakfast orally for 60 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary supplement consumption
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evolution of appetite sensation
Description
Satiety assessment, measured in eva scale (%)
Time Frame
It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Title
Sensation of appetite before intaking the product under investigation
Description
Satiety assessment, measured in eva scale (%)
Time Frame
It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Title
Area under the curve of the evolution of the appetite sensation from instant zero ingestion to instant ingestion of 60 minutes
Description
Satiety assessment, measured in eva scale (%)
Time Frame
It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Title
Average of the appetite sensation during the 60 minutes after intake of the experimented product
Description
Satiety assessment, measured in eva scale (%)
Time Frame
It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Title
Decrease in the sensation of appetite suffering from subjects when consuming the product in experimentation
Description
Satiety assessment, measured in eva scale (%)
Time Frame
It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Title
Area under the curve of the evolution of the appetite feeling from the 60 minutes post-intake instantly 240 minutes post-intake.
Description
Satiety assessment, measured in eva scale (%)
Time Frame
It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Title
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
Description
Satiety assessment, measured in eva scale (%)
Time Frame
It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Title
Appetite feeling immediately after ad-libitum food
Description
Satiety assessment, measured in eva scale (%)
Time Frame
It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Title
Amount of energy consumed during the ad-libitum meal
Description
Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test
Time Frame
It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Title
Satiety quotient (SQ)
Description
Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test
Time Frame
It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Secondary Outcome Measure Information:
Title
Insulinemia
Description
Hormonal analysis, measured in mU/L
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.
Title
Leptin
Description
Hormonal analysis, measured in ng/dL
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.
Title
Adiponectin
Description
Hormonal analysis, measured in µg/mL
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.
Title
Ghrelin (GHRL)
Description
Hormonal analysis, measured in ng/ml
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.
Title
Tyrosine Peptide Tyrosine (PYY)
Description
Hormonal analysis, measured in pg/mL
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.
Title
Glucagon Like Peptide - 1 (GLP-1)
Description
Hormonal analysis, measured in ng/mL
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.
Title
Blood glucose
Description
Glycidic analysis, measured in mg/dL
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.
Title
Glycosylated hemoglobin (HBA1c)
Description
Glycidic analysis, measured in %
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.
Title
Peripheral insulin resistance (HOMA-IR)
Description
Glycidic analysis
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.
Title
Total Cholesterol
Description
Lipidic profile, measured in mg/dl
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.
Title
LDL - Cholesterol
Description
Lipidic profile, measured in mg/dl
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.
Title
HDL - Cholesterol
Description
Lipidic profile, measured in mg/dl
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.
Title
Triglycerides
Description
Lipidic profile, measured in mg/dl
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.
Title
Fat mass
Description
Bioimpedance, in Kg. For this we will use a TANITA
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.
Title
Muscle mass
Description
Bioimpedance, in Kg. For this we will use a TANITA
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.
Title
Body mass index
Description
Bioimpedance, in Kg/m2. For this we will use a TANITA
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.
Title
Physical activity
Description
Measured in MET, with Actigraph wGT3X-BT
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.
Title
Gastrointestinal Quality of Life Test
Description
GIQLI
Time Frame
It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.
Title
Quality of Life Test
Description
WHOQOL BREF
Time Frame
It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.
Title
Liver safety variables
Description
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)
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Catholic University of Murcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain

12. IPD Sharing Statement

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Effectiveness of a Natural Ingredient on Appetite Regulation

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