Effectiveness of a Natural Ingredient on Appetite Regulation

NCT04345029 | Completed DMC

• 1 other identifier: UCAMCFE-00012
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetite Regulation; Overweight and Obesity

Outcome Measures

Primary Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (20)

• Insulinemia

  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

  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

  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)

  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)

  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.

Study Arms (2)

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.

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.

Dietary Supplement: Dietary supplement consumption

Interventions

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.

Experimental group (Lippia citriodora + sabdariffa); control group Placebo (sucrose)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 14, 2020
• Study Start: January 15, 2020
• Primary Completion: June 15, 2020
• Study Completion: June 30, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-04

Locations

ES (1)