Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05152745
Status:
COMPLETED
Last Update Posted:
2021-12-10
First Post:
2021-11-29
Brief Title:
Effect of Ginger Extract on Postprandial Glycaemia of Healthy Adults and Its Antioxidant Properties
Sponsor:
Egas Moniz - Cooperativa de Ensino Superior CRL
Organization:
Egas Moniz - Cooperativa de Ensino Superior CRL
Study Overview
Official Title:
Effect of Ginger Extract on Postprandial Glycemia of Healthy Adults and Its Antioxidant Properties a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n15 and control group GC n15 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
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 n15 and control group GC n15 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
Detailed Description:
This clinical trial was approved by Ethical Committee process number 519 at 23 November 2016 All participants signed a written informed consent after aim and experimental risk procedures explanation and its protected confidentiality was guaranteed The experimental procedure involving human was care out according Declaration of Helsinki
This blind to participants randomized controlled clinical trial was conducted at Egas Moniz higher education school in 30 nondiabetic adults Participants with ages between 18 and 40 were selected and randomly allocated in intervention group IG n15 and control group CG n15 in which participants were alternated include in the groups The IG performed an oral glucose tolerance test OGTT followed by aqueous ginger extract administration and the CG performed an OGTT administration alone
For ginger extract preparation powder ginger Zingibre officinalle Roscoe was obtained from Portugal Company with India origin and stored in a dried environmental locally until needed The product has a batch number of LI1GIGRNT150012 Powder ginger was individually weight 02g each dose and added to 100mL of boiled water obtaining the ginger extract infusing 10 minutes Ginger extract solution was after cooled at room temperature and distributed to each participant This method was adapted by Wilkinson J M 2000 For chemical analysis a aqueous ginger extract previously obtained was used
Regarding to blood glucose level assessment the blood sample were collected for each participant using a capillary drop blood before the intervention fasting and after 30 60 90 and 120 minutes The blood glucose level analysis was performed using a strips for glucose meter Onetouch Select Plus Flex a sterilized lancet and a glucose meter equipment
General characteristics data of the participants were collected namely anthropometrics data pharmacologic treatment and medical condition using a questionnaire In addition a 24-hour dietary recall at the day before the intervention was employing to sample participants The nutritional analyzed of diet ingested was performed by Food Processor SQL version 1050
The total phenolic compounds determination of the aqueous ginger extract was determined according to Folin-Ciocalteu method The total phenolic results were expressed as mg gallic acid equivalent GAEL of ginger extract A volume of 125 μL of ginger extract and 2 mL of sodium carbonate were added to 25 mL of Folin-Ciocalteu reagent After 15 min the absorbance was measured at 765 nm The flavonoids compounds determination of the aqueous ginger extract was determined according to Prabha method The flavonoids results were expressed as mg quercetin equivalent GAEL of ginger extract A volume of 2 mL of ginger extract were added to 01 mL of aluminum chloride anhydrous solution 10 01 mL of potassium acetate 1M and 28 mL of distilled water After 30 min the absorbance was measured at 415 nm
The antioxidant activity was measured through different assays
The superoxide anion radicals scavenging activity was determined based on Morais et al method Superoxide anion was generated by reacting phenazine methosulfate PMS nicotinamide adenine dinucleotide hydride NADH and oxygen causing reduced NBT in Formazan A volume of 05mL of sample was added to 05mL of a solution containing NADH 189 microM and NBT 120 microM with Tris-HCl 40mM pH 8 The reaction started after the addition of 05mL of PMS 60microM Control sample was measured using only distilled water After 5min of incubation control absorbance was measured at 560 nm at room temperature
The nitric oxide inhibitory activity was determined according Khayami et al method A volume of 1mL of sodium nitroprusside 10nm was added to 250microL de phosphate buffered saline PBS and 250microL of test solution and it was shaken The previous solution was incubated for 150 min at 25ºC and following add 3mL of sulfanilic acid and 033 of acetic acid glacial After 5 min at room temperature it was add 3mL of n-1-naphthylethylenediamine dihydrochloride NED 01 mv and incubated for 30 min at 25ºC The absorbance was measured at 533nm The previous procedure was employed to control obtained using water
The free radical 22-azino-bis 3-ethylbenzothiazoline-6-sulfonic acid ABTS was obtained by ABTS oxidation with potassium persulfate 140mM for 12h in dark according Zulueta et al method It was prepared a solution with 10mL ABTS 7nm and 176microL persulfate and storage at room temperature by 12h in dark The previous solution was diluted with ethanol until 07 absorbance at 734nm A volume of 2850microL of ABTS radical was added to 150microL of sample and to 150microL of water After 30min in dark the absorbance was determined at 734nm The Trolox concentration was using as standard mM TroloxL This test was performed for several extract concentrations in order to calculate IC50
Data statistical analysis was performed using SPSS Statistics Statistical Package for Social Sciences version 22 software Mean and standard error of the mean were used Shapiro-Wilk and Repeated Measures ANOVA of mixed type were used Independent samples T-test was used to assess the difference between the 2 groups for total caloric value carbohydrates protein and lipid ingested Cmax maximum concentration ΔCmax variation of maximum concentration and AUC area under the curve Incremental values The AUC was calculated by Software GraphPad Prim version 703 All statistical tests were performed at the 5 level of significance
This blind to participants randomized controlled clinical trial was conducted at Egas Moniz higher education school in 30 nondiabetic adults Participants with ages between 18 and 40 were selected and randomly allocated in intervention group IG n15 and control group CG n15 in which participants were alternated include in the groups The IG performed an oral glucose tolerance test OGTT followed by aqueous ginger extract administration and the CG performed an OGTT administration alone
For ginger extract preparation powder ginger Zingibre officinalle Roscoe was obtained from Portugal Company with India origin and stored in a dried environmental locally until needed The product has a batch number of LI1GIGRNT150012 Powder ginger was individually weight 02g each dose and added to 100mL of boiled water obtaining the ginger extract infusing 10 minutes Ginger extract solution was after cooled at room temperature and distributed to each participant This method was adapted by Wilkinson J M 2000 For chemical analysis a aqueous ginger extract previously obtained was used
Regarding to blood glucose level assessment the blood sample were collected for each participant using a capillary drop blood before the intervention fasting and after 30 60 90 and 120 minutes The blood glucose level analysis was performed using a strips for glucose meter Onetouch Select Plus Flex a sterilized lancet and a glucose meter equipment
General characteristics data of the participants were collected namely anthropometrics data pharmacologic treatment and medical condition using a questionnaire In addition a 24-hour dietary recall at the day before the intervention was employing to sample participants The nutritional analyzed of diet ingested was performed by Food Processor SQL version 1050
The total phenolic compounds determination of the aqueous ginger extract was determined according to Folin-Ciocalteu method The total phenolic results were expressed as mg gallic acid equivalent GAEL of ginger extract A volume of 125 μL of ginger extract and 2 mL of sodium carbonate were added to 25 mL of Folin-Ciocalteu reagent After 15 min the absorbance was measured at 765 nm The flavonoids compounds determination of the aqueous ginger extract was determined according to Prabha method The flavonoids results were expressed as mg quercetin equivalent GAEL of ginger extract A volume of 2 mL of ginger extract were added to 01 mL of aluminum chloride anhydrous solution 10 01 mL of potassium acetate 1M and 28 mL of distilled water After 30 min the absorbance was measured at 415 nm
The antioxidant activity was measured through different assays
The superoxide anion radicals scavenging activity was determined based on Morais et al method Superoxide anion was generated by reacting phenazine methosulfate PMS nicotinamide adenine dinucleotide hydride NADH and oxygen causing reduced NBT in Formazan A volume of 05mL of sample was added to 05mL of a solution containing NADH 189 microM and NBT 120 microM with Tris-HCl 40mM pH 8 The reaction started after the addition of 05mL of PMS 60microM Control sample was measured using only distilled water After 5min of incubation control absorbance was measured at 560 nm at room temperature
The nitric oxide inhibitory activity was determined according Khayami et al method A volume of 1mL of sodium nitroprusside 10nm was added to 250microL de phosphate buffered saline PBS and 250microL of test solution and it was shaken The previous solution was incubated for 150 min at 25ºC and following add 3mL of sulfanilic acid and 033 of acetic acid glacial After 5 min at room temperature it was add 3mL of n-1-naphthylethylenediamine dihydrochloride NED 01 mv and incubated for 30 min at 25ºC The absorbance was measured at 533nm The previous procedure was employed to control obtained using water
The free radical 22-azino-bis 3-ethylbenzothiazoline-6-sulfonic acid ABTS was obtained by ABTS oxidation with potassium persulfate 140mM for 12h in dark according Zulueta et al method It was prepared a solution with 10mL ABTS 7nm and 176microL persulfate and storage at room temperature by 12h in dark The previous solution was diluted with ethanol until 07 absorbance at 734nm A volume of 2850microL of ABTS radical was added to 150microL of sample and to 150microL of water After 30min in dark the absorbance was determined at 734nm The Trolox concentration was using as standard mM TroloxL This test was performed for several extract concentrations in order to calculate IC50
Data statistical analysis was performed using SPSS Statistics Statistical Package for Social Sciences version 22 software Mean and standard error of the mean were used Shapiro-Wilk and Repeated Measures ANOVA of mixed type were used Independent samples T-test was used to assess the difference between the 2 groups for total caloric value carbohydrates protein and lipid ingested Cmax maximum concentration ΔCmax variation of maximum concentration and AUC area under the curve Incremental values The AUC was calculated by Software GraphPad Prim version 703 All statistical tests were performed at the 5 level of significance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None