Healthy VolunteersNCT03089593
Thermogenic Effect of Ginger
A study testing Extract of ginger in people with Healthy Volunteers, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The main objective of the study is to evaluate the thermogenic effect of ginger. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Extract of ginger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Mar 2017to 14 Jun 2017
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females;
- Aged between 18 and 60 years old;
- Body mass index between 18.5 and 24.9 kg/m²;
- Agree to sign the informed consent.
Who cannot join
- Any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart and liver disease);
- Previous operation for weight loss;
- Medications known to affect total energy expenditure;
- Pregnancy and breast-feeding;
- Smoking;
- Alcohol use (>2 doses/day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind Placebo-controlled Clinical Trial of Thermogenic Effect of Ginger (Zingiber Officinale) in Eutrophic Women
The main objective of the study is to evaluate the thermogenic effect of ginger.
Read the detailed description
Healthy and eutrophic women will receive capsules of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose), along with a standardized breakfast, with a minimum seven days washout period.
- Conditions
- Healthy Volunteers
- Being tested
- Extract of ginger, Placebo (Cellulose)
- Keywords
- Thermic Effect of Food, Energy Expenditure, Ginger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extract of gingerOther
The volunteers will receive two capsules containing 200mg of extract of ginger with 5% of gingerols (20 mg). Breakfast will be offered (bread, butter, turkey ham and industrialized fruit juice) and the participants will have 15 minutes to eat it.
Placebo (Cellulose)Other
The volunteers will receive two capsules containing cellulose (placebo). Breakfast will be offered (bread, butter, turkey ham and industrialized fruit juice) and the participants will have 15 minutes to eat it.
| Study group | Role | What they receive |
|---|---|---|
| Extract of ginger | Experimental | Healthy and eutrophic women will receive two capsules of 200 mg of ginger extract (5% gingerols) to be taken along with a standardized breakfast. Receives: Other: Extract of ginger |
| Cellulose | Placebo comparator | Healthy and eutrophic women will receive two capsules of 200 mg of placebo (cellulose) to be taken along with a standardized breakfast. Receives: Other: Placebo (Cellulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial energy expenditure
Energy expenditure will be assessed by indirect calorimetry
Measured: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Secondary outcomes (7)
Change in oxygen consumption
Oxygen consumption will be assessed by indirect calorimetry
Measured: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in blood pressure
Blood pressure will be assessed using digital sphygmomanometer
Measured: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in axillary temperature
Axillary temperature will be assessed using a digital thermometer
Measured: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in metabolic profile
Total cholesterol
Measured: Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial
Change in heart rate
Heart rate will be assessed using digital sphygmomanometer
Measured: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in metabolic profile
Glucose levels
Measured: Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial
Change in metabolic profile
HDL-cholesterol
Measured: Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start27 Mar 2017
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adaliene Versiani M. Ferreira, Federal University of Minas Gerais
- Investigators
- Gabriela BP Fagundes, Study chair, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089593
- Sponsor's protocol ID
- UFMG 30409114.8.0000.5149
- Status last verified
- Jun 2017
- First submitted
- 8 Mar 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fagundes GBP, Rodrigues AMDS, Martins LB, Monteze NM, Correia MITD, Teixeira AL, Ferreira AVM. Acute effects of dry extract of ginger on energy expenditure in eutrophic women: A randomized clinical trial. Clin Nutr ESPEN. 2021 Feb;41:168-174. doi: 10.1016/j.clnesp.2020.10.001. Epub 2020 Nov 9.
PubMed 33487261
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo-controlled Clinical Trial of Thermogenic Effect of Ginger (Zingiber Officinale) in Eutrophic Women
- ClinicalTrials.gov ID
- NCT03089593
- Acronym / sponsor ID
- UFMG 30409114.8.0000.5149
- Conditions
- Healthy Volunteers
- Keywords
- Thermic Effect of Food, Energy Expenditure, Ginger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 24 Mar 2017 (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 main objective of the study is to evaluate the thermogenic effect of ginger.
Detailed description
Healthy and eutrophic women will receive capsules of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose), along with a standardized breakfast, with a minimum seven days washout period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extract of ginger | Experimental | Other: Extract of gingerHealthy and eutrophic women will receive two capsules of 200 mg of ginger extract (5% gingerols) to be taken along with a standardized breakfast. |
| Cellulose | Placebo comparator | Other: Placebo (Cellulose)Healthy and eutrophic women will receive two capsules of 200 mg of placebo (cellulose) to be taken along with a standardized breakfast. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females;
- Aged between 18 and 60 years old;
- Body mass index between 18.5 and 24.9 kg/m²;
- Agree to sign the informed consent.
Key exclusion criteria (6 listed)
- Any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart and liver disease);
- Previous operation for weight loss;
- Medications known to affect total energy expenditure;
- Pregnancy and breast-feeding;
- Smoking;
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 |
|---|---|---|
| Extract of gingerThe volunteers will receive two capsules containing 200mg of extract of ginger with 5% of gingerols (20 mg). Breakfast will be offered (bread, butter, turkey ham and industrialized fruit juice) and the participants will have 15 minutes to eat it. | Other | Extract of ginger |
| Placebo (Cellulose)The volunteers will receive two capsules containing cellulose (placebo). Breakfast will be offered (bread, butter, turkey ham and industrialized fruit juice) and the participants will have 15 minutes to eat it. | Other | Cellulose |
Primary outcome
Change in postprandial energy expenditure
Time frame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Energy expenditure will be assessed by indirect calorimetry
7 secondary outcomes
Change in oxygen consumption
Time frame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in blood pressure
Time frame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in axillary temperature
Time frame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in metabolic profile
Time frame: Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial
Change in heart rate
Time frame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in metabolic profile
Time frame: Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial
Change in metabolic profile
Time frame: Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial
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 21 Jun 2017.
- Derived from this study: PubMed 33487261Fagundes GBP, Rodrigues AMDS, Martins LB, Monteze NM, Correia MITD, Teixeira AL, Ferreira AVM. Acute effects of dry extract of ginger on energy expenditure in eutrophic women: A randomized clinical trial. Clin Nutr ESPEN. 2021 Feb;41:168-174. doi: 10.1016/j.clnesp.2020.10.001. Epub 2020 Nov 9.
- Individual participant dataSharing planned: Undecided
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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.
Gabriela BP Fagundes study chair
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extract of ginger in people with Healthy Volunteers, run by Federal University of Minas Gerais at 1 site in Brazil.
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 4 inclusion and 6 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 21 Jun 2017. 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 Brazil. 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?
Change in postprandial energy expenditure (time frame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03089593, which also lists 1 linked publication.
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 21 Jun 2017.