Official title: Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition in the Obesity Treatment and Improvement Behavioral Profile

Regarding its complex pathogenesis and clinic-epidemiological meaning, different strategies are needed for the treatment of obesity. Ginger is the rhizome of a plant with thermogenic and anti-inflammatory effects, and may be a promising alternative as add-on strategy in the treatment for obesity. The primary objective of the current study is to assess whether consumption of ginger as an add-on strategy to restrictive diet is effective to reduce fat body percentage, increase basal metabolic rate and improve loss weight.

The secondary objectives are:

to assess the effect of nutritional intervention in quality of diet and weight loss.
to evaluate the effect of ginger on behavioral symptoms and peripheral biomarkers in overweight subjects.

Read the detailed description

Overweight individuals will be interviewed at baseline and after 30, 60, 90, 120, 150 and 180 days from baseline. The following measures will be assessed: body composition (fat body% and free fat body%), anthropometric measures (height, weight, body mass index, waist circumference and abdominal circumference), blood pressure, basal metabolic rate, behavioral symptoms, binge eating (binge eating scale) and peripheral biomarkers. Behavioral symptoms will be assessed using the following self-reported questionnaires: Beck Depression Inventory (depression symptoms), Beck Anxiety Inventory (anxiety symptoms), Medical Outcomes Study 36 - Item Short - Form Health Survey (quality of life) and Perceived Stress Scale (stress).

Enrolled participants will receive restrictive diet calculated on individual requirements aiming at the loss from two to four kilogram per month in addition to capsules of ginger or placebo, as follows:

Group 1 will receive vials containing 90 capsules of 200mg of dry extract of ginger (5% active ingredient) to be taken three times a day for six months in addition to restrictive diet.
Group 2 will receive vials containing 90 capsules of 200mg of placebo (cellulose) to be taken three times a day for six months in addition to restrictive diet.

Conditions: Obesity
Being tested: Dry extract of ginger, Placebo
Keywords: ginger obesity, ginger inflammation, treatment of obesity
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dry extract of gingerDietary supplement
Restrictive diet plus three capsules of 200 mg of dry extract of ginger (5% active ingredient) to be taken three times a day for six months.
PlaceboDietary supplement
Restrictive diet plus three capsules of 200 mg of cellulose to be taken three times a day for six months.

Study groups in NCT02742194
Study group	Role	What they receive
Placebo	Placebo comparator	Conventional treatment (restrictive diet) plus capsules of 200 mg of cellulose (placebo) to be taken three times a day for six months. Receives: Dietary Supplement: Placebo
Ginger group	Experimental	Conventional treatment (restrictive diet) plus capsules of 200 mg of dry extract of ginger (5% active ingredient) to be taken three times a day for six months. Receives: Dietary Supplement: Dry extract of ginger

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in basal metabolic rate.
Ginger effect in basal metabolic rate will be measured by calorimetry.
Measured: Baseline and 30, 60, 90, 120, 150 and 180 days
Change in body fat percentage.
Ginger effect in body fat percentage will be measured by bioimpedance.
Measured: Baseline and 30, 60, 90, 120, 150 and 180 days

Secondary outcomes (7)

Changes in serum levels of inflammatory mediators
Nutritional effect in the levels of Interleukin-1, interleukin-6 and interleukin-10, tumor necrosis factor and protein C reactive.
Measured: Baseline and 30, 60, 90, 120, 150 and 180 days
Change in depressive symptoms.
Nutritional effect in depressive symptoms will be measured by the Beck Depression Inventory.
Measured: Baseline and 30, 60, 90, 120, 150 and 180 days
Change in anxiety symptoms.
Nutritional effect in anxiety symptoms will be measured by the Beck Anxiety Inventory.
Measured: Baseline and 30, 60, 90, 120, 150 and 180 days
Change in quality of life.
Nutritional effect in quality of life will be measured by Medical Outcomes Study 36 - Item Short - Form Health Survey.
Measured: Baseline and 30, 60, 90, 120, 150 and 180 days
Change in perceived stress.
Nutritional effect in perceived stress will be measured by the Perceived Stress Scale.
Measured: Baseline and 30, 60, 90, 120, 150 and 180 days
Change in quality of diet.
Nutritional effect in quality of diet will be measured by the Healthy Eating Index-10.
Measured: Baseline and 30, 60, 90, 120, 150 and 180 days
Changes in serum levels of neurotrophic factors
Nutritional effect in the serum levels of Brain-derived neurotrophic factor, glial-derived neurotrophic factor and neurotrophin-3 and neurotrophin 4/5.
Measured: Baseline and 30, 60, 90, 120, 150 and 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015Nov 2018

First posted18 Apr 2016 (estimated)
Study startAug 2015
Primary completionNov 2018 (estimated)
Study completionNov 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for ObesityStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02742194
Sponsor's protocol ID: CAAE 30409114.8.0000.5149
Status last verified: Apr 2016
First submitted: 5 Feb 2016
Last updated: 18 Apr 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

van Reedt Dortland AK, Giltay EJ, van Veen T, Zitman FG, Penninx BW. Longitudinal relationship of depressive and anxiety symptoms with dyslipidemia and abdominal obesity. Psychosom Med. 2013 Jan;75(1):83-9. doi: 10.1097/PSY.0b013e318274d30f. Epub 2012 Nov 28.
PubMed 23197842
Atashak S, Peeri M, Azarbayjani MA, Stannard SR, Haghighi MM. Obesity-related cardiovascular risk factors after long- term resistance training and ginger supplementation. J Sports Sci Med. 2011 Dec 1;10(4):685-91. eCollection 2011.
PubMed 24149559
Chrubasik S, Pittler MH, Roufogalis BD. Zingiberis rhizoma: a comprehensive review on the ginger effect and efficacy profiles. Phytomedicine. 2005 Sep;12(9):684-701. doi: 10.1016/j.phymed.2004.07.009.
PubMed 16194058
Gregersen NT, Belza A, Jensen MG, Ritz C, Bitz C, Hels O, Frandsen E, Mela DJ, Astrup A. Acute effects of mustard, horseradish, black pepper and ginger on energy expenditure, appetite, ad libitum energy intake and energy balance in human subjects. Br J Nutr. 2013 Feb 14;109(3):556-63. doi: 10.1017/S0007114512001201. Epub 2012 Jul 5.
PubMed 23021155
Saravanan G, Ponmurugan P, Deepa MA, Senthilkumar B. Anti-obesity action of gingerol: effect on lipid profile, insulin, leptin, amylase and lipase in male obese rats induced by a high-fat diet. J Sci Food Agric. 2014 Nov;94(14):2972-7. doi: 10.1002/jsfa.6642. Epub 2014 Apr 7.
PubMed 24615565

Want to know more?

Antônio L Teixeira, PhD

+55 31 3409-8073

altexr@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition in the Obesity Treatment and Improvement Behavioral Profile
ClinicalTrials.gov ID: NCT02742194
Acronym / sponsor ID: CAAE 30409114.8.0000.5149
Conditions: Obesity
Keywords: ginger obesity, ginger inflammation, treatment of obesity
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 84 participants (estimated)
Lead sponsor: Federal University of Minas GeraisUniversity, hospital or other
Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
Study start: Aug 2015
Primary completion: Nov 2018 (estimated)
Study completion: Nov 2018 (estimated)
First posted: 18 Apr 2016 (estimated)
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 secondary objectives are:

to assess the effect of nutritional intervention in quality of diet and weight loss.
to evaluate the effect of ginger on behavioral symptoms and peripheral biomarkers in overweight subjects.

Detailed description

Group 1 will receive vials containing 90 capsules of 200mg of dry extract of ginger (5% active ingredient) to be taken three times a day for six months in addition to restrictive diet.
Group 2 will receive vials containing 90 capsules of 200mg of placebo (cellulose) to be taken three times a day for six months in addition to restrictive diet.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Dietary Supplement: PlaceboConventional treatment (restrictive diet) plus capsules of 200 mg of cellulose (placebo) to be taken three times a day for six months.
Ginger group	Experimental	Dietary Supplement: Dry extract of gingerConventional treatment (restrictive diet) plus capsules of 200 mg of dry extract of ginger (5% active ingredient) to be taken three times a day for six months.

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Women aged 18-60 years old;
Body mass index 25-35 kg/m².

Key exclusion criteria (5 listed)

Pregnant or lactating women;
Abuse of alcohol or drugs;
Hypersensitivity to ginger;
Other endocrine disease;
Women in use of insulin or anti-inflammatory and antidepressants 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
Dry extract of gingerRestrictive diet plus three capsules of 200 mg of dry extract of ginger (5% active ingredient) to be taken three times a day for six months.	Dietary supplement	Ginger group
PlaceboRestrictive diet plus three capsules of 200 mg of cellulose to be taken three times a day for six months.	Dietary supplement	Placebo

Primary outcome

Change in basal metabolic rate.
Time frame: Baseline and 30, 60, 90, 120, 150 and 180 days
Ginger effect in basal metabolic rate will be measured by calorimetry.
Change in body fat percentage.
Time frame: Baseline and 30, 60, 90, 120, 150 and 180 days
Ginger effect in body fat percentage will be measured by bioimpedance.

7 secondary outcomes

Changes in serum levels of inflammatory mediators
Time frame: Baseline and 30, 60, 90, 120, 150 and 180 days
Change in depressive symptoms.
Time frame: Baseline and 30, 60, 90, 120, 150 and 180 days
Change in anxiety symptoms.
Time frame: Baseline and 30, 60, 90, 120, 150 and 180 days
Change in quality of life.
Time frame: Baseline and 30, 60, 90, 120, 150 and 180 days
Change in perceived stress.
Time frame: Baseline and 30, 60, 90, 120, 150 and 180 days
Change in quality of diet.
Time frame: Baseline and 30, 60, 90, 120, 150 and 180 days
Changes in serum levels of neurotrophic factors
Time frame: Baseline and 30, 60, 90, 120, 150 and 180 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
Background: PubMed 23197842van Reedt Dortland AK, Giltay EJ, van Veen T, Zitman FG, Penninx BW. Longitudinal relationship of depressive and anxiety symptoms with dyslipidemia and abdominal obesity. Psychosom Med. 2013 Jan;75(1):83-9. doi: 10.1097/PSY.0b013e318274d30f. Epub 2012 Nov 28.
Background: PubMed 24149559Atashak S, Peeri M, Azarbayjani MA, Stannard SR, Haghighi MM. Obesity-related cardiovascular risk factors after long- term resistance training and ginger supplementation. J Sports Sci Med. 2011 Dec 1;10(4):685-91. eCollection 2011.
Background: PubMed 16194058Chrubasik S, Pittler MH, Roufogalis BD. Zingiberis rhizoma: a comprehensive review on the ginger effect and efficacy profiles. Phytomedicine. 2005 Sep;12(9):684-701. doi: 10.1016/j.phymed.2004.07.009.
Background: PubMed 23021155Gregersen NT, Belza A, Jensen MG, Ritz C, Bitz C, Hels O, Frandsen E, Mela DJ, Astrup A. Acute effects of mustard, horseradish, black pepper and ginger on energy expenditure, appetite, ad libitum energy intake and energy balance in human subjects. Br J Nutr. 2013 Feb 14;109(3):556-63. doi: 10.1017/S0007114512001201. Epub 2012 Jul 5.
Background: PubMed 24615565Saravanan G, Ponmurugan P, Deepa MA, Senthilkumar B. Anti-obesity action of gingerol: effect on lipid profile, insulin, leptin, amylase and lipase in male obese rats induced by a high-fat diet. J Sci Food Agric. 2014 Nov;94(14):2972-7. doi: 10.1002/jsfa.6642. Epub 2014 Apr 7.
Individual participant dataSharing planned: No

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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Obesity & Overweight, Vitamin D
Recruiting
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Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

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.

Antônio L Teixeira, PhD contact

+55 31 3409-8073

altexr@gmail.com

Antônio L Teixeira, PhD contact

+553134098073

altexr@gmail.com

Adaliene VM Ferreira, PhD study director

Federal University of Minas Gerais

Nayara M Monteze, Ma study chair

Federal University of Minas Gerais

Antônio L Teixeira, PhD principal investigator

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 Phase 2 study testing Dry extract of ginger in people with Obesity, 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Apr 2016. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Antônio L Teixeira, PhD (+55 31 3409-8073, altexr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in basal metabolic rate. (time frame: Baseline and 30, 60, 90, 120, 150 and 180 days). The study lists 2 primary outcomes in all. 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 NCT02742194, which also lists 5 linked publications.

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 18 Apr 2016.