Metabolic SyndromeNCT03568877
Effect of Metabolaid® on AMPK Activation for Weight Loss
A study testing Metabolaid® in people with Metabolic Syndrome, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 36 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Metabolaid®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with a body mass index (BMI) from 24 to 34 kg/m2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Metabolaid®, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolaid®Dietary supplement
500 mg per day, in fasting conditions.
PlaceboDietary supplement
500 mg per day, in fasting conditions.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | 2 capsules per day, each with 400 mg Cellulose microcrystalline, for 8 weeks Receives: Dietary Supplement: Placebo |
| Dietetic Supplement Group | Experimental | 2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 8 weeks Receives: Dietary Supplement: Metabolaid® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body Weight, using a weight scale
In Kg
Measured: At the beginning, four weeks and end of the intervention, total eight weeks.
Secondary outcomes (10)
Height, using measuring tape
In cm
Measured: At the beginning, four weeks and eight weeks
BMI, calculated based on Weight and Height
in kg/m^2
Measured: At the beginning, four weeks and eight weeks
Waist Circumference, using a measuring tape
in kg/m^2
Measured: At the beginning, four weeks and eight weeks
Glucose
Blood Sampling in Fasting conditions, in mg/dl
Measured: At the beginning, four weeks and eight weeks
Tryglicerides
Blood Sampling in Fasting conditions, in mg/dl
Measured: At the beginning, four weeks and eight weeks
LDL Cholesterol
Blood Sampling in Fasting conditions, in mg/dl
Measured: At the beginning, four weeks and eight weeks
HDL Cholesterol
Blood Sampling in Fasting conditions, in mg/dl
Measured: At the beginning, four weeks and eight weeks
Total Cholesterol
Blood Sampling in Fasting conditions, in mg/dl
Measured: At the beginning, four weeks and eight weeks
Blood Pressure
Single Blood Pressure measurements, using the Omron M6 Comfort device
Measured: At the beginning, four weeks and eight weeks
Heart rate
Single Blood Pressure measurements, using the Omron M6 Comfort device
Measured: At the beginning, four weeks and eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Monteloeder SL
- Responsible party
- Principal investigator, María Herranz-Lopez, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568877
- Sponsor's protocol ID
- UniversidadMHE_Met AMPK
- Status last verified
- Jun 2018
- First submitted
- 30 May 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-obesity Effects of Metabolaid® With AMPK-activating Capacity in Overweight Subjects: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03568877
- Acronym / sponsor ID
- UniversidadMHE_Met AMPK
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Monteloeder SL
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Control | Placebo comparator | Dietary Supplement: Placebo2 capsules per day, each with 400 mg Cellulose microcrystalline, for 8 weeks |
| Dietetic Supplement Group | Experimental | Dietary Supplement: Metabolaid®2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 8 weeks |
Who may qualify
- Ages
- 36 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants with a body mass index (BMI) from 24 to 34 kg/m2
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolaid®500 mg per day, in fasting conditions. | Dietary supplement | Dietetic Supplement Group |
| Placebo500 mg per day, in fasting conditions. | Dietary supplement | Placebo Control |
Primary outcome
Changes in body Weight, using a weight scale
Time frame: At the beginning, four weeks and end of the intervention, total eight weeks.
In Kg
10 secondary outcomes
Height, using measuring tape
Time frame: At the beginning, four weeks and eight weeks
BMI, calculated based on Weight and Height
Time frame: At the beginning, four weeks and eight weeks
Waist Circumference, using a measuring tape
Time frame: At the beginning, four weeks and eight weeks
Glucose
Time frame: At the beginning, four weeks and eight weeks
Tryglicerides
Time frame: At the beginning, four weeks and eight weeks
LDL Cholesterol
Time frame: At the beginning, four weeks and eight weeks
HDL Cholesterol
Time frame: At the beginning, four weeks and eight weeks
Total Cholesterol
Time frame: At the beginning, four weeks and eight weeks
Blood Pressure
Time frame: At the beginning, four weeks and eight weeks
Heart rate
Time frame: At the beginning, four weeks and eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolaid® in people with Metabolic Syndrome, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body Weight, using a weight scale (time frame: At the beginning, four weeks and end of the intervention, total eight weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.