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

Primary Purpose

Diet, Mediterranean, Antioxidant Effect, Body Weight

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Metabolaid(R)
Nutraceutical placebo
Sponsored by
University of Alicante
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diet, Mediterranean

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alejandro Martínez RodríguezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

CONTROL GROUP

EXPERIMENTAL GROUP

Arm Description

Nutraceutical placebo intake group

Intake of natural herbal dietary supplement composed of a combination of Hibiscus sabdariffa flowers and Lippia citriodora leaves.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 7, 2023
Last Updated
October 2, 2023
Sponsor
University of Alicante
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1. Study Identification

Unique Protocol Identification Number
NCT05906771
Brief Title
Study of the Effect of the Combined Extract of Lemon Verbena and Hibiscus on Health Indicators
Official Title
Study of the Effect of the Combined Extract of Lemon Verbena and Hibiscus on Health Indicators
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alicante

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, Mediterranean, Antioxidant Effect, Body Weight, Cardiovascular Diseases, Densitometry, Body Composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CONTROL GROUP
Arm Type
Placebo Comparator
Arm Description
Nutraceutical placebo intake group
Arm Title
EXPERIMENTAL GROUP
Arm Type
Experimental
Arm Description
Intake of natural herbal dietary supplement composed of a combination of Hibiscus sabdariffa flowers and Lippia citriodora leaves.
Intervention Type
Dietary Supplement
Intervention Name(s)
Metabolaid(R)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutraceutical placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
WEIGHT
Description
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
Time Frame
12 weeks
Title
HEIGHT
Description
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
Time Frame
12 weeks
Title
BLOOD PREASURE
Description
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Time Frame
12 weeks
Title
FAT MASS
Description
Assessment of body composition by DXA and bioimpedance to obtain fat mass results.
Time Frame
12 weeks
Title
HEART RATE
Description
Measurement of heart rate with a digital tensiometer.
Time Frame
12 weeks
Title
SATIETY
Description
Scores will be obtained through validated questionnaires for the study of satiety of the participating subjects.
Time Frame
12 weeks
Title
BLOOD CHOLESTEROL LEVEL
Description
Cholesterol blood values will be obtained using the flexible and portable accutrend® plus
Time Frame
12 weeks
Title
TRIGLICERIDES
Description
Triglicerides blood values will be obtained using the flexible and portable accutrend® plus
Time Frame
12 weeks
Title
BLOOD GLUCOSE LEVEL
Description
Glucose blood values will be obtained using the flexible and portable accutrend® plus
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Alejandro Martínez Rodríguez
City
Elche
State/Province
Alicante
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Martínez
Phone
696210163
Email
amartinezrodriguez@ua.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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