Effect of Metabolaid® on AMPK Activation for Weight Loss

NCT ID: NCT03568877

Last Updated: 2018-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study was to establish a formulation, containing both Hibiscus sabdariffa L. (HS) and Lippia citriodora L. (LC) extracts (Metabolaid®) that had significant capacity to activate the AMPK-enzyme and to reduce triglyceride accumulation in the hypertrophied adipocyte model. Then, we assessed the efficacy of this combination in light-to-moderate-overweight subjects under risk of developing metabolic syndrome.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

AMP-activated protein kinase (AMPK) has been postulated as a molecular target in the amelioration of obesity-related diseases, where most therapeutic approaches have failed. Plant-polyphenols have shown the capacity to ameliorate obesity-induced metabolic disturbances. A combination of polyphenols (LC-HS) derived from Hibiscus sabdariffa L. (HS) and Lippia citriodora L. (LC) (lemon verbena) (Metabolaid®) was assessed for triglyceride accumulation and AMPK activation in the hypertrophied adipocyte model 3T3-L1. A dietary supplement containing 500 mg of LC-HS was evaluated in a double blind, placebo-controlled and randomized trial in 56 overweight subjects for two months. Anthropometric and circulating biochemical parameters were determined.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo Control

2 capsules per day, each with 400 mg Cellulose microcrystalline, for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

500 mg per day, in fasting conditions.

Dietetic Supplement Group

2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 8 weeks

Group Type EXPERIMENTAL

Metabolaid®

Intervention Type DIETARY_SUPPLEMENT

500 mg per day, in fasting conditions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metabolaid®

500 mg per day, in fasting conditions.

Intervention Type DIETARY_SUPPLEMENT

Placebo

500 mg per day, in fasting conditions.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants with a body mass index (BMI) from 24 to 34 kg/m2

Exclusion Criteria

* total cholesterol lower than 200 mg/dL.
* use of prescription medication for cholesterol or hypertension.
* presence of any obesity-related pathology.
* hormone replacement therapy.
* consumption of antioxidant supplements/drugs.
* alcohol addiction.
* women who were pregnant or lactating.
Minimum Eligible Age

36 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Monteloeder SL

UNKNOWN

Sponsor Role collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

María Herranz-Lopez

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad Miguel Hernandez de Elche

Elche, Alicante, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UniversidadMHE_Met AMPK

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effectiveness of MD on MetS Patients
NCT06961682 NOT_YET_RECRUITING NA