Study of the Effect of the Combined Extract of Lemon Verbena and Hibiscus on Health Indicators

Plant polyphenols have demonstrated the ability to ameliorate metabolic alterations induced by overweight and obesity, both in cellular and animal models, where most therapeutic approaches have failed. These have demonstrated the ability to improve appetite sensation, leading to improved body weight control, in addition to reducing fat accumulation and improving plasma glycemic and lipid profiles, as well as inflammatory process and vascular dysfunction. The plant polyphenols on which the extract to be studied will be based will be hibiscus and lemon verbena. A randomized controlled trial will be carried out in overweight or obese subjects from the province of Alicante. An electronic randomization will be carried out based on a two-branch design, therefore, there will be a control group (no intervention) and an experimental group (nutraceutical intake). Participants will have to ingest the nutraceutical for 3 months, as well as attend the agreed visits. Different satiety questionnaires, circulating parameters measured in capillaries (cholesterol, triglycerides and glucose), blood pressure and body composition measured by bone densitometry (DXA) will be collected. All variables will be measured at 4 different time points (baseline, 30 days, 60 days and 90 days). All these will be analyzed as a function of time; at the beginning and end of each intervention (intra-group analysis), as well as comparing the control group with the experimental group (inter-group analysis). A multidisciplinary team formed by physicians, nurses and nutritionists will be involved.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Body Weight; Body Composition; Diet, Mediterranean; Antioxidant Effect; Densitometry
• Intervention / Treatment: Dietary supplement: Nutraceutical placebo; Dietary supplement: Metabolaid(R)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain
      • Recruiting
      • Alejandro Martínez Rodríguez
      • Contact: Alejandro Martínez; Phone Number: 696210163; Email: amartinezrodriguez@ua.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Elderly (< 18 years)
• Overweight (body mass index 25-29.9 kg/m2)

Exclusion Criteria:

• Pregnant or lactating subjects
• Who have participated in another study with similar characteristics in the last 3 months.
• Subjects with pathologies.
• Consumption of drugs and/or supplements
• Subjects with food intolerances/allergies.
• Subjects with muscle or joint injury.
• Subjects with impossibility to follow up the intervention.
• Refusal of informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: CONTROL GROUP; Nutraceutical placebo intake group	Dietary supplement: Nutraceutical placebo; The participating subjects will have to follow the intake of the nutraceutical for 3 months, as well as attend the stipulated visits. Participants will be given a register to control their daily intake of the nutraceutical. They should not change their daily habits. Nutraceutical placebo contains microcystalline cellulose (185mg) and maltodextrin (185mg).
Experimental: EXPERIMENTAL GROUP; Intake of natural herbal dietary supplement composed of a combination of Hibiscus sabdariffa flowers and Lippia citriodora leaves.	Dietary supplement: Metabolaid(R); The participating subjects will have to follow the intake of the nutraceutical for 3 months, as well as attend the stipulated visits. Participants will be given a register to control their daily intake of the nutraceutical. They should not change their daily habits. The nutraceutical has been elaborated by Monteloeder, S.L. It is a combination of Hibiscus sabdariffa flowers and Lippia citriodora leaves. The dose that the participants of the experimental group will receive will be 300mg plus 20mg of microcrystalline cellulose. The product is presented in an unflavored capsule, it is a reddish-brown powder with a characteristic odor and a slightly bitter taste. The manufacturing date of the product was 01/12/2022 and the expiration date was 30/11/2024.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WEIGHT	The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).	12 weeks
HEIGHT	The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).	12 weeks
BLOOD PREASURE	Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.	12 weeks
FAT MASS	Assessment of body composition by DXA and bioimpedance to obtain fat mass results.	12 weeks
HEART RATE	Measurement of heart rate with a digital tensiometer.	12 weeks
SATIETY	Scores will be obtained through validated questionnaires for the study of satiety of the participating subjects.	12 weeks
BLOOD CHOLESTEROL LEVEL	Cholesterol blood values will be obtained using the flexible and portable accutrend® plus	12 weeks
TRIGLICERIDES	Triglicerides blood values will be obtained using the flexible and portable accutrend® plus	12 weeks
BLOOD GLUCOSE LEVEL	Glucose blood values will be obtained using the flexible and portable accutrend® plus	12 weeks

Collaborators and Investigators

• Sponsor: University of Alicante

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Body Weight
• Other Study ID Numbers: UA-2023-05-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No