NCT03089593

Brief Summary

The main objective of the study is to evaluate the thermogenic effect of ginger.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

March 27, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2017

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

March 8, 2017

Last Update Submit

June 20, 2017

Conditions

Keywords

Thermic Effect of FoodEnergy ExpenditureGinger

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

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.

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.

Other: Placebo (Cellulose)

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.

Extract of ginger

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.

Cellulose

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

MeSH Terms

Interventions

Cellulose

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Gabriela BP Fagundes

    Federal University of Minas Gerais

    STUDY CHAIR

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

Locations