Pre-meal High-performance Inulin Supplementation in Healthy Non-diabetic Subjects

Diet, Healthy Clinical Trial

Official title:

Pre-meal High-performance Inulin Supplementation Reduce Post-prandial Glycaemic Response in Healthy Non Diabetic Subjects : a Repeated Single-arm Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04994353
• Other study ID #: 131/WM12/KEPK/DOSEN/T/2020
• Status: Completed
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: January 19, 2021

Study information

• Verified date: August 2021
• Source: Universitas Katolik Widya Mandala Surabaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 19, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diet, Healthy

Intervention

Dietary Supplement:
• No supplementation
1st Week: No supplementation
• High Performance (HP) Inulin
2nd Week: Subjects consumed 20% v/v HP Inulin. Ingredients: 20 gram HP-Inulin diluted with 100 ml distilled water.
• Isomalto-oligosaccharide (IMO)
3rd Week: Subjects consumed 20% v/v Isomalto-oligosaccharide (IMO). Ingredients: 20 gram IMO diluted with 100 ml distilled water.
• Combination HP-Inulin and IMO
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 solution
5th Week:Subjects consumed20% v/v Dextrose solution. Ingredients: 20 gram Dextrose powder diluted with 100 ml distilled water.
• Glucose solution
6th Week:Subjects consumed 20% v/v Glucose solution. Ingredients: 20 gram glucose diluted with 100 ml distilled water.

Locations

Country	Name	City	State
Indonesia	Universitas Katolik Widya Mandala Surabaya	Surabaya	Jawa Timur

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Katolik Widya Mandala Surabaya

Country where clinical trial is conducted

Indonesia, 

References & Publications (3)

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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). pii: E2204. doi: 10.3390/nu12082204. Review. — View Citation

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose at T=0	Postprandial Blood glucose concentration	0 minutes after intervention and meal
Primary	Blood Glucose at T=30 min	Postprandial Blood glucose concentration	30 minutes after intervention and meal
Primary	Blood Glucose at T=60 min	Postprandial Blood glucose concentration	60 minutes after intervention and meal
Primary	Blood Glucose at T=90 min	Postprandial Blood glucose concentration	90 minutes after intervention and meal
Primary	Blood Glucose at T=120 min	Postprandial Blood glucose concentration	120 minutes after intervention and meal