Effect of Metabolaid® on AMPK Activation for Weight Loss

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Metabolaid®
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 36 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |