NCT05152745

Brief Summary

Background: Hyperglycemia is a risk factor to disease development, namely, diabetes mellitus. The blood glucose level management, particularly on post-prandial period has an important role in the prevention of different diseases. Ginger is a specie that has been demonstrated a benefit effect on glycaemia on diabetes. Aim: The aim of this study was 1) to investigate the effects of ginger infusion in the glycaemic response in nondiabetic adults; 2) to evaluate total phenolic content the antioxidant activity of Ginger (Zingiber officinale Roscoe) aqueous extracts. Methodology: 24 nondiabetic subjects were randomly allocated into two groups: intervention group (GI; n=15) and control group (GC; n=15). An oral glucose solution (OGTT) and an OGTT following ginger extract solution were administrated in control and intervention groups, respectively. Blood glucose levels were measurement at fasting and after 30, 60, 90 and 120 minutes after interventions in both groups. Total phenolic content and flavonoids compounds determination of the aqueous ginger extract was determined according to Prabha method. Antioxidant activity was also measured through ABTS method and free radicals inhibition capacity. Repeated Measures ANOVA of mixed type and independent samples t-test were used in statistical analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
Last Updated

December 10, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

November 29, 2021

Last Update Submit

December 9, 2021

Conditions

Keywords

Ginger, hyperglycemia, antioxidant, phenols, flavonoids

Outcome Measures

Primary Outcomes (6)

  • Postprandial blood glucose levels time curve

    Mean blood glucose levels (mmol/L) obtained after oral glucose tolerance test in control group and after oral glucose tolerance test plus baobab extract in intervention group at different moments

    up to 120 minutes after intervention

  • Incremental area under the curve of glucose levels

    the blood glucose incremental area under the curve (AUCi) of each participant was defined using the GraphPad Prism program (version 5.0).

    At 120 minutes after intervention

  • Blood glucose maximum concentrations

    Mean blood glucose levels (mmol/L)

    At 60 minutos after intervention

  • Antioxidant activity determination of Ginger extract

    Mean values of anion and radical inhibition capacity and mean values of antioxidant capacity by ABTS (micromol TE/g)

    At baseline

  • Total phenolic compounds

    Mean values of total phenolic compounds (mg of gallic acid/g ginger)

    At baseline

  • Flavonoids

    Mean values of flavonoids (mg quercetin of/g ginger)

    At baseline

Secondary Outcomes (3)

  • Weight of participants

    At baseline

  • Body mass index of participants

    At baseline

  • Height of participants

    At baseline

Study Arms (2)

Placebo (OGTT)

PLACEBO COMPARATOR

The control group participants ingested glucose solution alone (OGTT) prepared with 75 g of anhydrous oral glucose as prescribed by the ADA, dissolved in 200 ml of water.

Other: Placebo OGGT

Intervention (OGTT plus Ginger extract)

EXPERIMENTAL

The intervention group ingested glucose solution followed by 100 ml of ginger aqueous extract (0.2g ginger, each dose).

Other: Ginger aqueous extract

Interventions

After overnight fasting, blood glucose level was assessed through a capillary drop blood The control group participants ingested glucose solution alone (OGTT) prepared with 75 g of anhydrous oral glucose as prescribed by the ADA, dissolved in 200 ml of water. Blood glucose level was also measured at 30 (t30), 60 (t60), 90 (t90) and 120 (t120) minutes immediately after intervention, for each participant, in control and intervention groups. Glucometer equipment, strips for glucose meters (One Touch Select Plus) and sterilized lancets (Sarstedt normal 21G) were used to measure blood glucose concentrations, taking due care of safety and asepsis.

Placebo (OGTT)

After overnight fasting, blood glucose level was assessed through a capillary drop blood The intervention group participants ingested glucose solution alone (OGTT) prepared with 75 g of anhydrous oral glucose as prescribed by the ADA, dissolved in 200 ml of water, followed by 100mL of ginger extract (0.2g). Blood glucose level was also measured at 30 (t30), 60 (t60), 90 (t90) and 120 (t120) minutes immediately after intervention, for each participant, in control and intervention groups. Glucometer equipment, strips for glucose meters (One Touch Select Plus) and sterilized lancets (Sarstedt normal 21G) were used to measure blood glucose concentrations, taking due care of safety and asepsis.

Intervention (OGTT plus Ginger extract)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • subjects without glucose metabolism alteration

You may not qualify if:

  • medication for glycemia
  • had gastrointestinal symptoms or disease
  • pregnancy or lactation
  • had allergy to ginger.
  • to ingest ginger at the day before the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Universitário Egas Moniz

Almada, Monte de Caparica, 2829-511, Portugal

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Maria Fernanda Mesquita

    Centro de Investigação Interdisciplinar Egas Moniz, Instituto Universitário Egas Moniz, Portugal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 10, 2021

Study Start

May 5, 2017

Primary Completion

July 30, 2017

Study Completion

October 30, 2017

Last Updated

December 10, 2021

Record last verified: 2021-11

Locations