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

Sponsor

University of Alicante (Other)

Overall Status

Recruiting

CT.gov ID

NCT05906771

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diet, Mediterranean Antioxidant Effect Body Weight Cardiovascular Diseases Densitometry Body Composition	Dietary Supplement: Metabolaid(R) Dietary Supplement: Nutraceutical placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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.

Arm

Intervention/Treatment

Placebo Comparator: CONTROL GROUP

Nutraceutical placebo intake group

Dietary Supplement: Nutraceutical placebo

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alejandro Martínez Rodríguez	Elche	Alicante	Spain

Sponsors and Collaborators

University of Alicante

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Dr. Alejandro Martínez-Rodríguez, Full Professor, University of Alicante

ClinicalTrials.gov Identifier:

NCT05906771

Other Study ID Numbers:

UA-2023-05-08

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Body Weight

Study Results

No Results Posted as of Jun 18, 2023