Diet, HealthyNCT04994353
Pre-meal High-performance Inulin Supplementation in Healthy Non-diabetic Subjects
A study testing No supplementation, High Performance (HP) Inulin and Isomalto-oligosaccharide (IMO) in people with Diet, Healthy, run by Universitas Katolik Widya Mandala Surabaya at 1 site in Indonesia.
Trial summary
In a double-blind, repeated single-arm trial, 8 healthy adults consumed 20 grams of formula that contain 60.2% inulin (w/w) dissolved in 100 ml of water. Blood glucose was measured in fasted participants and at, 30, 60, 90, and 120 minutes after starting to eat a prepared meal (470 Kcal). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- No supplementation, High Performance (HP) Inulin and Isomalto-oligosaccharide (IMO)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Dec 2020to 19 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index (BMI) between 18.5-25.0
- normal diet
- not under any medication
- not having any history of metabolic diseases
- not having abnormalities such as systemic hypertension (resting blood pressure more than 140/90 mmHg), impaired glucose tolerance (fasting blood glucose concentration between 100-126 mg/dL and oral glucose tolerance test or OGTT more than 140 mg/dL), and non-alcoholic fatty liver diseases (NAFLD).
Who cannot join
- Subjects were excluded if they had an acute infection pregnant, gastrointestinal disease, cardiovascular disease, renal disease, pancreatic disease, and take any medication during or 1 week before trial.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Katolik Widya Mandala Surabaya
Surabaya, East Java, 60112
About this study
Official title: Pre-meal High-performance Inulin Supplementation Reduce Post-prandial Glycaemic Response in Healthy Non Diabetic Subjects : a Repeated Single-arm Clinical Trial
In a double-blind, repeated single-arm trial, 8 healthy adults consumed 20 grams of formula that contain 60.2% inulin (w/w) dissolved in 100 ml of water. Blood glucose was measured in fasted participants and at, 30, 60, 90, and 120 minutes after starting to eat a prepared meal (470 Kcal). As supplementation controls, the investigators used the vehicle-glucose, dextrose, isomaltooligosaccharides (IMO), or the combination of IMO and Inulin solution 20% (w/v).
Read the detailed description
Subjects In this trial, 8 healthy subjects (6 women and 2 men), aged between 23-37 years old were voluntarily recruited. Inclusion criteria were: healthy men or women aged between 18-50 years old, body mass index (BMI) between 18.5-25.0, normal diet, not under any medication, and not having any history of metabolic diseases or abnormalities such as systemic hypertension (resting blood pressure more than 140/90 mmHg), impaired glucose tolerance (fasting blood glucose concentration between 100-126 mg/dL and oral glucose tolerance test or OGTT more than 140 mg/dL), and non-alcoholic fatty liver diseases (NAFLD). Subjects were excluded if they had an acute infection, pregnant, gastrointestinal disease, cardiovascular disease, renal disease, pancreatic disease, and take any medication during or 1 week before trial. At the beginning of the trial, demographic data including age, sex, history of diseases, medication, diet, and physical activities within 3 days were collected using a questionnaire form. Bodyweight was measured using Omron digital scale HN286 (PT. Omron Manufacturing of Indonesia). Body height was measured using a stature meter. To determine the amount of daily calorie expenditure for selection of the suitable ready-meal, the estimated energy requirements (EER) were calculated based on the harris-benedict formula as previously reported45, with the physical activity level 1.0 (sedentary activity). This research was approved by the Health Research Ethics Committee of Widya Mandala Catholic University Surabaya (No. 131/WM12/KEPK/DOSEN/T/2020).
Experimental design This experimental design adapted a single-arm trial analysis. A group of 8 subjects received intervention with single pre-meal supplementation. After that, the glycaemic response was measured (see blood sampling preparation). This intervention was repeated every week with five different supplementation formulae (see below) for five consecutive weeks. The difference in their glycaemic response after meal for every intervention was measured and analyzed statistically.
Supplement preparation: Inulin formulations, isomaltooligosaccharides formulations, the combination of inulin and isomaltooligosaccharides formulations, dextrose solution, and vehicle-glucose formulations.
For the first week, the investigators measured glycaemic response to a meal without any intervention and use those data as a baseline. For the intervention, the investigators used the untreated control without supplementation (NS), HP Inulin formulations (IF), isomaltooligosaccharides/IMO formulations (IM, this formulation is marketed as Fibercreme®), the combination of HP inulin and IMO formula (MF), dextrose solution (DS), and vehicle-glucose formulations (VO) in the form of powder. All the supplementation formulas are purchased from PT. Lautan Natural Krimerindo (Mojokerto, Jawa Timur, Indonesia). The detailed composition of each formulation could be seen in Supplementary Table 1. For the preparation of 20% IF, IM, and MF solution, 20 grams of designated powder was diluted in 100 ml distilled water. For 20% DS, 20 grams of purified dextrose monohydrate was diluted in 100 ml distilled water. IMO solution was chosen as a control because IMO could act as partially digestible dietary fibre.43 Vehicle-glucose could act as a negative control for IF intervention because IF contains similar ingredients with the IF, but instead of inulin, glucose syrup was added as the caloric source.
Intervention: fasting, pre-meal supplementation, and meal Three days before the intervention, every subject was informed to maintain their normal diet, physical activities, and enough sleep (6-8 hours/day). All subjects fasted 10-12 hours before the intervention. Supplement formula solution 20% (w/v) then given orally before a meal for five consecutive weeks in the following orders: IF in the first week, followed by IM in the second week, MF in the third week, DS in the fourth week, and VO in the last week. The meal for experimental subjects was given after intervention and contained 470 kcal "Ready Meal". The amount of calories in "Ready-Meal" is 25-30% from the calculated EER (see table 1). The macronutrient composition of the "Ready Meal" was purchased from PT. Charoen Pokphand Indonesia,TbK (Jakarta, Indonesia) was listed in supplementary table 2.
Blood sampling preparation, blood glucose, and glycaemic response (iAUC) measurement.
An intravenous cannula was inserted into the cubital vein to provide access to repeated glucose measurement. Peripheral vein whole blood samples were taken for analysis of glucose concentration using a commercially available FreeStyle Optium glucose monitoring system (Abbot Laboratories, Chicago, Illinois, USA). Blood glucose was measured at 0, 30, 60, 90, and 120 minutes after intervention and meal. The first measurement at 0 representing the fasting plasma glucose (FPG), that is the blood glucose concentration after an overnight fast (10-12 hours). The glycaemic response measurement unit at 0, 30, 60, 90, and 120 minutes for each subject was described as the incremental area under the curve (iAUC). The iAUC refers to actual body exposure to certain substances after their administration. The AUC depends on the rate of substance elimination from the body and its dose of administration. iAUC calculation (symbolized with A) was carried out using a linear trapezoidal method and formula (see supplementary figure 1) as described in the literature.44
- Conditions
- Diet, Healthy
- Being tested
- No supplementation, High Performance (HP) Inulin, Isomalto-oligosaccharide (IMO), Combination HP-Inulin and IMO, Dextrose solution
- Keywords
- high performance inulin, glycaemic index, blood glucose, pre-meal, post-prandial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No supplementationDietary supplement
1st Week: No supplementation
High Performance (HP) InulinDietary supplement
2nd Week: Subjects consumed 20% v/v HP Inulin. Ingredients: 20 gram HP-Inulin diluted with 100 ml distilled water.
Isomalto-oligosaccharide (IMO)Dietary supplement
3rd Week: Subjects consumed 20% v/v Isomalto-oligosaccharide (IMO). Ingredients: 20 gram IMO diluted with 100 ml distilled water.
Combination HP-Inulin and IMODietary supplement
4th Week: Subjects consumed20% v/v combination of HP-Inulin and Isomalto-oligosaccharide (IMO).
Ingredients: 20 gram IMO-HP Inulin "Mix" diluted with 100 ml distilled water.
Dextrose solutionDietary supplement
5th Week:Subjects consumed20% v/v Dextrose solution. Ingredients: 20 gram Dextrose powder diluted with 100 ml distilled water.
Glucose solutionDietary supplement
6th Week:Subjects consumed 20% v/v Glucose solution. Ingredients: 20 gram glucose diluted with 100 ml distilled water.
| Study group | Role | What they receive |
|---|---|---|
| Supplementation | Experimental | Three days before the intervention, every subject was informed to maintain their normal diet, physical activities, and enough sleep (6-8 hours/day). All subjects fasted 10-12 hours before the intervention. An intravenous cannula was inserted into the cubital vein to provide access to repeated glucose measurement. Peripheral vein whole blood samples were taken for analysis of glucose concentration using a commercially available FreeStyle Optium glucose monitoring system (Abbot Laboratories, Chicago, Illinois, USA) .For the first week, we measured blood glucose to a meal without any intervention and use those data as a baseline. After that, blood glucose was measured at 0, 30, 60, 90, and 120 minutes after intervention and meal. After intervention, the subjects maintain daily predefined ready-meal (470 kcal). The supplementation formulas are "food grade", purchased from PT. Lautan Natural Krimerindo (Mojokerto, Jawa Timur, Indonesia). Receives: Dietary Supplement: No supplementation; Dietary Supplement: High Performance (HP) Inulin; Dietary Supplement: Isomalto-oligosaccharide (IMO); Dietary Supplement: Combination HP-Inulin and IMO; Dietary Supplement: Dextrose solution; Dietary Supplement: Glucose solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose at T=0
Postprandial Blood glucose concentration
Measured: 0 minutes after intervention and meal
Blood Glucose at T=30 min
Postprandial Blood glucose concentration
Measured: 30 minutes after intervention and meal
Blood Glucose at T=60 min
Postprandial Blood glucose concentration
Measured: 60 minutes after intervention and meal
Blood Glucose at T=90 min
Postprandial Blood glucose concentration
Measured: 90 minutes after intervention and meal
Blood Glucose at T=120 min
Postprandial Blood glucose concentration
Measured: 120 minutes after intervention and meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start14 Dec 2020
- Primary completion19 Jan 2021
- Study completion19 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Katolik Widya Mandala Surabaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hendy Wijaya, Universitas Katolik Widya Mandala Surabaya
- Investigators
- Hendy Wijaya, MD.M.Biomed., Principal investigator, Faculty of Pharmacy, Universitas Katolik Widya Mandala Surabaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994353
- Sponsor's protocol ID
- 131/WM12/KEPK/DOSEN/T/2020
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fevre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gonzalez-Medina D, Gosselin R, Grainger R, Grant B, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Laden F, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Levinson D, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mock C, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leon FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiebe N, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, AlMazroa MA, Memish ZA. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2197-223. doi: 10.1016/S0140-6736(12)61689-4.
PubMed 23245608GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1151-1210. doi: 10.1016/S0140-6736(17)32152-9.
PubMed 28919116Lambadiari V, Korakas E, Tsimihodimos V. The Impact of Dietary Glycemic Index and Glycemic Load on Postprandial Lipid Kinetics, Dyslipidemia and Cardiovascular Risk. Nutrients. 2020 Jul 24;12(8):2204. doi: 10.3390/nu12082204.
PubMed 32722053
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-meal High-performance Inulin Supplementation Reduce Post-prandial Glycaemic Response in Healthy Non Diabetic Subjects : a Repeated Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT04994353
- Acronym / sponsor ID
- 131/WM12/KEPK/DOSEN/T/2020
- Conditions
- Diet, Healthy
- Keywords
- high performance inulin, glycaemic index, blood glucose, pre-meal, post-prandial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Universitas Katolik Widya Mandala SurabayaUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 6 Aug 2021 (actual)
- 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.
In a double-blind, repeated single-arm trial, 8 healthy adults consumed 20 grams of formula that contain 60.2% inulin (w/w) dissolved in 100 ml of water. Blood glucose was measured in fasted participants and at, 30, 60, 90, and 120 minutes after starting to eat a prepared meal (470 Kcal). As supplementation controls, the investigators used the vehicle-glucose, dextrose, isomaltooligosaccharides (IMO), or the combination of IMO and Inulin solution 20% (w/v).
Detailed description
Subjects In this trial, 8 healthy subjects (6 women and 2 men), aged between 23-37 years old were voluntarily recruited. Inclusion criteria were: healthy men or women aged between 18-50 years old, body mass index (BMI) between 18.5-25.0, normal diet, not under any medication, and not having any history of metabolic diseases or abnormalities such as systemic hypertension (resting blood pressure more than 140/90 mmHg), impaired glucose tolerance (fasting blood glucose concentration between 100-126 mg/dL and oral glucose tolerance test or OGTT more than 140 mg/dL), and non-alcoholic fatty liver diseases (NAFLD). Subjects were excluded if they had an acute infection, pregnant, gastrointestinal disease, cardiovascular disease, renal disease, pancreatic disease, and take any medication during or 1 week before trial. At the beginning of the trial, demographic data including age, sex, history of diseases, medication, diet, and physical activities within 3 days were collected using a questionnaire form. Bodyweight was measured using Omron digital scale HN286 (PT. Omron Manufacturing of Indonesia). Body height was measured using a stature meter. To determine the amount of daily calorie expenditure for selection of the suitable ready-meal, the estimated energy requirements (EER) were calculated based on the harris-benedict formula as previously reported45, with the physical activity level 1.0 (sedentary activity). This research was approved by the Health Research Ethics Committee of Widya Mandala Catholic University Surabaya (No. 131/WM12/KEPK/DOSEN/T/2020).
Experimental design This experimental design adapted a single-arm trial analysis. A group of 8 subjects received intervention with single pre-meal supplementation. After that, the glycaemic response was measured (see blood sampling preparation). This intervention was repeated every week with five different supplementation formulae (see below) for five consecutive weeks. The difference in their glycaemic response after meal for every intervention was measured and analyzed statistically.
Supplement preparation: Inulin formulations, isomaltooligosaccharides formulations, the combination of inulin and isomaltooligosaccharides formulations, dextrose solution, and vehicle-glucose formulations.
For the first week, the investigators measured glycaemic response to a meal without any intervention and use those data as a baseline. For the intervention, the investigators used the untreated control without supplementation (NS), HP Inulin formulations (IF), isomaltooligosaccharides/IMO formulations (IM, this formulation is marketed as Fibercreme®), the combination of HP inulin and IMO formula (MF), dextrose solution (DS), and vehicle-glucose formulations (VO) in the form of powder. All the supplementation formulas are purchased from PT. Lautan Natural Krimerindo (Mojokerto, Jawa Timur, Indonesia). The detailed composition of each formulation could be seen in Supplementary Table 1. For the preparation of 20% IF, IM, and MF solution, 20 grams of designated powder was diluted in 100 ml distilled water. For 20% DS, 20 grams of purified dextrose monohydrate was diluted in 100 ml distilled water. IMO solution was chosen as a control because IMO could act as partially digestible dietary fibre.43 Vehicle-glucose could act as a negative control for IF intervention because IF contains similar ingredients with the IF, but instead of inulin, glucose syrup was added as the caloric source.
Intervention: fasting, pre-meal supplementation, and meal Three days before the intervention, every subject was informed to maintain their normal diet, physical activities, and enough sleep (6-8 hours/day). All subjects fasted 10-12 hours before the intervention. Supplement formula solution 20% (w/v) then given orally before a meal for five consecutive weeks in the following orders: IF in the first week, followed by IM in the second week, MF in the third week, DS in the fourth week, and VO in the last week. The meal for experimental subjects was given after intervention and contained 470 kcal "Ready Meal". The amount of calories in "Ready-Meal" is 25-30% from the calculated EER (see table 1). The macronutrient composition of the "Ready Meal" was purchased from PT. Charoen Pokphand Indonesia,TbK (Jakarta, Indonesia) was listed in supplementary table 2.
Blood sampling preparation, blood glucose, and glycaemic response (iAUC) measurement.
An intravenous cannula was inserted into the cubital vein to provide access to repeated glucose measurement. Peripheral vein whole blood samples were taken for analysis of glucose concentration using a commercially available FreeStyle Optium glucose monitoring system (Abbot Laboratories, Chicago, Illinois, USA). Blood glucose was measured at 0, 30, 60, 90, and 120 minutes after intervention and meal. The first measurement at 0 representing the fasting plasma glucose (FPG), that is the blood glucose concentration after an overnight fast (10-12 hours). The glycaemic response measurement unit at 0, 30, 60, 90, and 120 minutes for each subject was described as the incremental area under the curve (iAUC). The iAUC refers to actual body exposure to certain substances after their administration. The AUC depends on the rate of substance elimination from the body and its dose of administration. iAUC calculation (symbolized with A) was carried out using a linear trapezoidal method and formula (see supplementary figure 1) as described in the literature.44
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supplementation | Experimental | Dietary Supplement: No supplementation, Dietary Supplement: High Performance (HP) Inulin, Dietary Supplement: Isomalto-oligosaccharide (IMO), Dietary Supplement: Combination HP-Inulin and IMO, Dietary Supplement: Dextrose solution, Dietary Supplement: Glucose solutionThree days before the intervention, every subject was informed to maintain their normal diet, physical activities, and enough sleep (6-8 hours/day). All subjects fasted 10-12 hours before the intervention. An intravenous cannula was inserted into the cubital vein to provide access to repeated glucose measurement. Peripheral vein whole blood samples were taken for analysis of glucose concentration using a commercially available FreeStyle Optium glucose monitoring system (Abbot Laboratories, Chicago, Illinois, USA) .For the first week, we measured blood glucose to a meal without any intervention and use those data as a baseline. After that, blood glucose was measured at 0, 30, 60, 90, and 120 minutes after intervention and meal. After intervention, the subjects maintain daily predefined ready-meal (470 kcal). The supplementation formulas are "food grade", purchased from PT. Lautan Natural Krimerindo (Mojokerto, Jawa Timur, Indonesia). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- body mass index (BMI) between 18.5-25.0
- normal diet
- not under any medication
- not having any history of metabolic diseases
- not having abnormalities such as systemic hypertension (resting blood pressure more than 140/90 mmHg), impaired glucose tolerance (fasting blood glucose concentration between 100-126 mg/dL and oral glucose tolerance test or OGTT more than 140 mg/dL), and non-alcoholic fatty liver diseases (NAFLD).
Key exclusion criteria (1 listed)
- Subjects were excluded if they had an acute infection pregnant, gastrointestinal disease, cardiovascular disease, renal disease, pancreatic disease, and take any medication during or 1 week before trial.
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 |
|---|---|---|
| No supplementation1st Week: No supplementation | Dietary supplement | Supplementation |
| High Performance (HP) Inulin2nd Week: Subjects consumed 20% v/v HP Inulin. Ingredients: 20 gram HP-Inulin diluted with 100 ml distilled water. | Dietary supplement | Supplementation |
| Isomalto-oligosaccharide (IMO)3rd Week: Subjects consumed 20% v/v Isomalto-oligosaccharide (IMO). Ingredients: 20 gram IMO diluted with 100 ml distilled water. | Dietary supplement | Supplementation |
| Combination HP-Inulin and IMO4th Week: Subjects consumed20% v/v combination of HP-Inulin and Isomalto-oligosaccharide (IMO). Ingredients: 20 gram IMO-HP Inulin "Mix" diluted with 100 ml distilled water. | Dietary supplement | Supplementation |
| Dextrose solution5th Week:Subjects consumed20% v/v Dextrose solution. Ingredients: 20 gram Dextrose powder diluted with 100 ml distilled water. | Dietary supplement | Supplementation |
| Glucose solution6th Week:Subjects consumed 20% v/v Glucose solution. Ingredients: 20 gram glucose diluted with 100 ml distilled water. | Dietary supplement | Supplementation |
Primary outcome
Blood Glucose at T=0
Time frame: 0 minutes after intervention and meal
Postprandial Blood glucose concentration
Blood Glucose at T=30 min
Time frame: 30 minutes after intervention and meal
Postprandial Blood glucose concentration
Blood Glucose at T=60 min
Time frame: 60 minutes after intervention and meal
Postprandial Blood glucose concentration
Blood Glucose at T=90 min
Time frame: 90 minutes after intervention and meal
Postprandial Blood glucose concentration
Blood Glucose at T=120 min
Time frame: 120 minutes after intervention and meal
Postprandial Blood glucose concentration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Background: PubMed 23245608Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fevre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gonzalez-Medina D, Gosselin R, Grainger R, Grant B, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Laden F, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Levinson D, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mock C, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leon FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiebe N, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, AlMazroa MA, Memish ZA. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2197-223. doi: 10.1016/S0140-6736(12)61689-4.
- Background: PubMed 28919116GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1151-1210. doi: 10.1016/S0140-6736(17)32152-9.
- Results publication: PubMed 32722053Lambadiari V, Korakas E, Tsimihodimos V. The Impact of Dietary Glycemic Index and Glycemic Load on Postprandial Lipid Kinetics, Dyslipidemia and Cardiovascular Risk. Nutrients. 2020 Jul 24;12(8):2204. doi: 10.3390/nu12082204.
- Individual participant dataSharing planned: No
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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.
Hendy Wijaya, MD.M.Biomed. principal investigator
Faculty of Pharmacy, Universitas Katolik Widya Mandala Surabaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No supplementation, High Performance (HP) Inulin and Isomalto-oligosaccharide (IMO) in people with Diet, Healthy, run by Universitas Katolik Widya Mandala Surabaya at 1 site in Indonesia.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 6 Aug 2021. 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 Indonesia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose at T=0 (time frame: 0 minutes after intervention and meal). The study lists 5 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 NCT04994353, which also lists 3 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 6 Aug 2021.