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Completed

NCT Number: NCT04345029

Effectiveness of a Natural Ingredient on Appetite Regulation

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.

Completed

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Key information

Conditions

Appetite Regulation Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary supplement consumption

Dietary 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.

Primary outcomes

  1. 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 (%)

  2. 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 (%)

  3. 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 (%)

  4. 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 (%)

  5. 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 (%)

  6. 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 (%)

  7. 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 (%)

  8. 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 (%)

  9. 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

  10. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

    Hormonal analysis, measured in ng/ml

  5. 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.

    Hormonal analysis, measured in pg/mL

  6. 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

  7. 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

  8. 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 %

  9. 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.

    Glycidic analysis

  10. 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.

    Lipidic profile, measured in mg/dl

  11. 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.

    Lipidic profile, measured in mg/dl

  12. 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.

    Lipidic profile, measured in mg/dl

  13. 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.

    Lipidic profile, measured in mg/dl

  14. 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.

    Bioimpedance, in Kg. For this we will use a TANITA

  15. 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.

    Bioimpedance, in Kg. For this we will use a TANITA

  16. 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.

    Bioimpedance, in Kg/m2. For this we will use a TANITA

  17. 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.

    Measured in MET, with Actigraph wGT3X-BT

  18. 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

  19. 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

  20. 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.

    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)

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Randomized Controlled Trial of Efficacy of a Natural Ingredient on Appetite Regulation in Overweight / Obese Patients Grade I

Acronym: SAC

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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