Thermogenic Effect of Ginger
Double-blind Placebo-controlled Clinical Trial of Thermogenic Effect of Ginger (Zingiber Officinale) in Eutrophic Women
1 other identifier
interventional
20
1 country
1
Brief Summary
The main objective of the study is to evaluate the thermogenic effect of ginger.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy-volunteers
Started Mar 2017
Shorter than P25 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
March 24, 2017
CompletedStudy Start
First participant enrolled
March 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2017
CompletedJune 21, 2017
June 1, 2017
3 months
March 8, 2017
June 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in postprandial energy expenditure
Energy expenditure will be assessed by indirect calorimetry
Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Secondary Outcomes (7)
Change in oxygen consumption
Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in blood pressure
Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in axillary temperature
Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in metabolic profile
Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial
Change in heart rate
Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
- +2 more secondary outcomes
Study Arms (2)
Extract of ginger
EXPERIMENTALHealthy 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 COMPARATORHealthy and eutrophic women will receive two capsules of 200 mg of placebo (cellulose) to be taken along with a standardized breakfast.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Related Publications (1)
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.
PMID: 33487261DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gabriela BP Fagundes
Federal University of Minas Gerais
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, PhD
Study Record Dates
First Submitted
March 8, 2017
First Posted
March 24, 2017
Study Start
March 27, 2017
Primary Completion
June 14, 2017
Study Completion
June 14, 2017
Last Updated
June 21, 2017
Record last verified: 2017-06