Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04345029
Other study ID # UCAMCFE-00012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2020
Est. completion date June 30, 2020

Study information

Verified date April 2020
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 30, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Dietary supplement consumption
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.

Locations

Country Name City State
Spain Catholic University of Murcia Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution of appetite sensation 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)
Primary Sensation of appetite before intaking the product under investigation 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)
Primary 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 (%) It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary Average of the appetite sensation during the 60 minutes after intake of the experimented 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)
Primary Decrease in the sensation of appetite suffering from subjects when consuming the product in experimentation 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)
Primary 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 (%) It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary 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 (%) It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary Appetite feeling immediately after ad-libitum food 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)
Primary 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 It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary Satiety quotient (SQ) Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Secondary Insulinemia 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.
Secondary Leptin 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.
Secondary Adiponectin 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.
Secondary Ghrelin (GHRL) 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.
Secondary Tyrosine Peptide Tyrosine (PYY) 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.
Secondary Glucagon Like Peptide - 1 (GLP-1) 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.
Secondary Blood glucose Glycidic analysis, measured in mg/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.
Secondary Glycosylated hemoglobin (HBA1c) Glycidic analysis, measured in % It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary Peripheral insulin resistance (HOMA-IR) Glycidic analysis It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary Total Cholesterol Lipidic profile, measured in mg/dl It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary LDL - Cholesterol Lipidic profile, measured in mg/dl It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary HDL - Cholesterol Lipidic profile, measured in mg/dl It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary Triglycerides Lipidic profile, measured in mg/dl It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary Fat mass 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.
Secondary Muscle mass 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.
Secondary Body mass index 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.
Secondary Physical activity Measured in MET, with Actigraph wGT3X-BT It will be measured for 3 days before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary Gastrointestinal Quality of Life Test GIQLI It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary Quality of Life Test WHOQOL BREF It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary 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) It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Recruiting NCT05354245 - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL) N/A
Completed NCT03602001 - Attentive Eating for Weight Loss N/A
Recruiting NCT06269159 - The Power of 24-hour: Co-designing Intervention Components
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02996864 - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II N/A
Completed NCT04647149 - Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity N/A
Terminated NCT03914066 - A Group-based Treatment of Overweight and Obesity in Primary Care N/A
Completed NCT03685656 - Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers N/A
Completed NCT05051579 - A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities Phase 2
Completed NCT04611477 - Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals N/A
Active, not recruiting NCT05330247 - Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study N/A
Completed NCT03599115 - Effects of Inhibitory Control Training in Eating Behaviors N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Recruiting NCT05938894 - Train Your Brain - Executive Function N/A
Recruiting NCT05987306 - A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss N/A
Completed NCT03792685 - Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention N/A
Completed NCT05055362 - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study N/A
Completed NCT04520256 - Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy Phase 2/Phase 3
Completed NCT04979234 - A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome N/A