Pre-meal High-performance Inulin Supplementation in Healthy Non-diabetic Subjects
Condition: Diet, Healthy
Study type: Interventional

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).
    

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
    

Intervention name(s): No supplementation; High Performance (HP) Inulin; Isomalto-oligosaccharide (IMO); Combination HP-Inulin and IMO; Dextrose solution; Glucose solution
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1st Week: No supplementation; 2nd Week: Subjects consumed 20% v/v HP Inulin. Ingredients: 20 gram HP-Inulin diluted with 100 ml distilled water.; 3rd Week: Subjects consumed 20% v/v Isomalto-oligosaccharide (IMO). Ingredients: 20 gram IMO diluted with 100 ml distilled water.; 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.; 5th Week:Subjects consumed20% v/v Dextrose solution. Ingredients: 20 gram Dextrose powder diluted with 100 ml distilled water.; 6th Week:Subjects consumed 20% v/v Glucose solution. Ingredients: 20 gram glucose diluted with 100 ml distilled water.
Intervention MeSH terms: Pharmaceutical Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: high performance inulin; glycaemic index; blood glucose; pre-meal; post-prandial