Effectiveness of a Natural Ingredient on Obesity

NCT04105192 | Completed DMC

• 1 other identifier: UCAMCFE-0010
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

randomized, placebo-controlled clinical trial, with two parallel branches whose objective is to evaluate the efficacy of the product investigated on blood pressure and fat mass of subjects without pharmacotherapy.

Conditions

Overweight and Obesity; High Blood Pressure

Outcome Measures

Primary Outcomes (3)

• Total fat mass

  Dual X-ray absorptiometry (DEXA), measured in grams.

  From baseline to 84 days

• Fat mass in torso

  Dual X-ray absorptiometry (DEXA), measured in grams.

  From baseline to 84 days

• Fat mass in lower limbs

  Dual X-ray absorptiometry (DEXA), measured in grams.

  From baseline to 84 days

Secondary Outcomes (9)

• Fat mass

  Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.

• Muscle mass

  Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.

• Percentage of fat mass

  Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.

• blood samples: Glucidal metabolism and lipid metabolism.

  Time Frame: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use.

• Subjective sensation of product consumption

  Time Frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.

Study Arms (2)

experimental group (Lippia citriodora + sabdariffa)

EXPERIMENTAL

Consumption for 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg. Two capsules per day will be consumed thirty minutes before breakfast orally for 84 days.

Dietary Supplement: dietary supplement consumption

control group Placebo (sucrose)

PLACEBO COMPARATOR

Consumption for 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg or Placebo (sucrose) Two capsules per day will be consumed thirty minutes before breakfast orally for 84 days.

Dietary Supplement: dietary supplement consumption

Interventions

dietary supplement consumption DIETARY_SUPPLEMENT

Consumption of the product under study for 84 days, plecebo or experimental product

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

Eligibility Criteria

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

You may qualify if:

• Subjects of both sexes with age between 18-65 years.
• Subjects with a body mass index greater than 25 and less than 35.
• Volunteers capable of understanding the clinical study and willing to comply with the procedures and requirements of the study.

You may not qualify if:

• Subjects under treatment that may affect body weight.
• Subjects with acute diseases.
• Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathology or malignant tumor disease.
• Subjects undergoing major surgery in the last 3 months.
• Subjects who quit smoking in the last 6 months or who intend to quit during the study.
• Subjects with allergies or eating disorders.
• Volunteers who are participating in another study that includes blood draws or dietary intervention.
• Pregnant or breastfeeding woman.
• Subjects whose condition does not make them eligible for the study, according to the researcher.

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; Hypertension

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 26, 2019
• Study Start: March 1, 2019
• Primary Completion: November 20, 2019
• Study Completion: November 25, 2019
• Last Updated: April 1, 2020

Record last verified: 2020-03

Locations

ES (1)