Effect of Metabolaid® on AMPK Activation for Weight Loss

Metabolic Syndrome Clinical Trial

Official title:

Anti-obesity Effects of Metabolaid® With AMPK-activating Capacity in Overweight Subjects: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03568877
• Other study ID #: UniversidadMHE_Met AMPK
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: June 2018
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 36 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Dietary Supplement:
• Metabolaid®
500 mg per day, in fasting conditions.
• Placebo
500 mg per day, in fasting conditions.

Locations

Country	Name	City	State
Spain	Universidad Miguel Hernandez de Elche	Elche	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Monteloeder SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body Weight, using a weight scale	In Kg	At the beginning, four weeks and end of the intervention, total eight weeks.
Secondary	Height, using measuring tape	In cm	At the beginning, four weeks and eight weeks
Secondary	BMI, calculated based on Weight and Height	in kg/m^2	At the beginning, four weeks and eight weeks
Secondary	Waist Circumference, using a measuring tape	in kg/m^2	At the beginning, four weeks and eight weeks
Secondary	Glucose	Blood Sampling in Fasting conditions, in mg/dl	At the beginning, four weeks and eight weeks
Secondary	Tryglicerides	Blood Sampling in Fasting conditions, in mg/dl	At the beginning, four weeks and eight weeks
Secondary	LDL Cholesterol	Blood Sampling in Fasting conditions, in mg/dl	At the beginning, four weeks and eight weeks
Secondary	HDL Cholesterol	Blood Sampling in Fasting conditions, in mg/dl	At the beginning, four weeks and eight weeks
Secondary	Total Cholesterol	Blood Sampling in Fasting conditions, in mg/dl	At the beginning, four weeks and eight weeks
Secondary	Blood Pressure	Single Blood Pressure measurements, using the Omron M6 Comfort device	At the beginning, four weeks and eight weeks
Secondary	Heart rate	Single Blood Pressure measurements, using the Omron M6 Comfort device	At the beginning, four weeks and eight weeks