Effect of Metabolaid® on AMPK Activation for Weight Loss

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Metabolaid®

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Universidad Miguel Hernandez de Elche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control; 2 capsules per day, each with 400 mg Cellulose microcrystalline, for 8 weeks	Dietary supplement: Placebo; 500 mg per day, in fasting conditions.
Experimental: Dietetic Supplement Group; 2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 8 weeks	Dietary supplement: Metabolaid®; 500 mg per day, in fasting conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body Weight, using a weight scale	In Kg	At the beginning, four weeks and end of the intervention, total eight weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height, using measuring tape	In cm	At the beginning, four weeks and eight weeks
BMI, calculated based on Weight and Height	in kg/m^2	At the beginning, four weeks and eight weeks
Waist Circumference, using a measuring tape	in kg/m^2	At the beginning, four weeks and eight weeks
Glucose	Blood Sampling in Fasting conditions, in mg/dl	At the beginning, four weeks and eight weeks
Tryglicerides	Blood Sampling in Fasting conditions, in mg/dl	At the beginning, four weeks and eight weeks
LDL Cholesterol	Blood Sampling in Fasting conditions, in mg/dl	At the beginning, four weeks and eight weeks
HDL Cholesterol	Blood Sampling in Fasting conditions, in mg/dl	At the beginning, four weeks and eight weeks
Total Cholesterol	Blood Sampling in Fasting conditions, in mg/dl	At the beginning, four weeks and eight weeks
Blood Pressure	Single Blood Pressure measurements, using the Omron M6 Comfort device	At the beginning, four weeks and eight weeks
Heart rate	Single Blood Pressure measurements, using the Omron M6 Comfort device	At the beginning, four weeks and eight weeks

Collaborators and Investigators

• Sponsor: Universidad Miguel Hernandez de Elche
• Collaborators: Monteloeder SL

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: UniversidadMHE_Met AMPK

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