NCT04994353

Brief 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). As supplementation controls, the investigators used the vehicle-glucose, dextrose, isomaltooligosaccharides (IMO), or the combination of IMO and Inulin solution 20% (w/v).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

July 27, 2021

Last Update Submit

August 5, 2021

Conditions

Diet, Healthy

Keywords

high performance inulinglycaemic indexblood glucosepre-mealpost-prandial

Outcome Measures

Primary Outcomes (5)

  • Blood Glucose at T=0

    Postprandial Blood glucose concentration

    0 minutes after intervention and meal

  • Blood Glucose at T=30 min

    Postprandial Blood glucose concentration

    30 minutes after intervention and meal

  • Blood Glucose at T=60 min

    Postprandial Blood glucose concentration

    60 minutes after intervention and meal

  • Blood Glucose at T=90 min

    Postprandial Blood glucose concentration

    90 minutes after intervention and meal

  • Blood Glucose at T=120 min

    Postprandial Blood glucose concentration

    120 minutes after intervention and meal

Study Arms (1)

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).

Dietary Supplement: No supplementationDietary Supplement: High Performance (HP) InulinDietary Supplement: Isomalto-oligosaccharide (IMO)Dietary Supplement: Combination HP-Inulin and IMODietary Supplement: Dextrose solutionDietary Supplement: Glucose solution

Interventions

No supplementationDIETARY_SUPPLEMENT

1st Week: No supplementation

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.

Supplementation
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.

Supplementation
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.

Supplementation
Dextrose solutionDIETARY_SUPPLEMENT

5th Week:Subjects consumed20% v/v Dextrose solution. Ingredients: 20 gram Dextrose powder diluted with 100 ml distilled water.

Supplementation
Glucose solutionDIETARY_SUPPLEMENT

6th Week:Subjects consumed 20% v/v Glucose solution. Ingredients: 20 gram glucose diluted with 100 ml distilled water.

Supplementation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Katolik Widya Mandala Surabaya

Surabaya, East Java, 60112, Indonesia

Location

Related Publications (3)

  • 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.

    PMID: 23245608BACKGROUND

  • GBD 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.

    PMID: 28919116BACKGROUND

  • Lambadiari 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.

    PMID: 32722053RESULT

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Hendy Wijaya, MD.M.Biomed.

    Faculty of Pharmacy, Universitas Katolik Widya Mandala Surabaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 6, 2021

Study Start

December 14, 2020

Primary Completion

January 19, 2021

Study Completion

January 19, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)