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Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

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Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

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Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
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Bioavailability Study Design: Absolute Versus Relative Bioavailability01:27

Bioavailability Study Design: Absolute Versus Relative Bioavailability

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Bioavailability is a crucial pharmacokinetic parameter that quantifies the proportion of an administered drug that reaches the systemic circulation and is available for therapeutic action. Regulatory agencies mandate the assessment of bioavailability, typically measured as the area under the drug plasma concentration-versus-time curve (AUC), to ensure the efficacy and safety of pharmaceutical products. These evaluations are categorized as absolute and relative bioavailability studies.Absolute...
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Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

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Body:Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to...
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Blind Procedures02:07

Blind Procedures

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Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
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Updated: Dec 13, 2025

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A Randomized, Double-Blind, Crossover Study to Determine the Available Energy from Soluble Fiber.

Kirstie Canene-Adams1, Lisa Spence1,2, Lore W Kolberg1

  • 1Innovation and Commercial Development, Tate & Lyle, Hoffman Estates, Illinois, USA.

Journal of the American College of Nutrition
|July 31, 2020
PubMed
Summary

The available energy of PROMITOR® Soluble Corn Fiber products was determined to be 0.2 kcal/gram. This study found no significant difference in energy content between SCF70 and SCF85B, offering valuable data for food labeling.

Keywords:
Clinical trialbreath hydrogencaloric determinationfibermetabolism

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Area of Science:

  • Nutritional Science
  • Human Metabolism
  • Dietary Fiber Research

Background:

  • Accurate caloric information for dietary fibers is crucial for food manufacturers.
  • Fermentation of non-digestible fibers by gut microbes yields short-chain fatty acids and available energy.
  • Understanding the available energy of soluble fiber products aids in product reformulation and accurate food labeling.

Purpose of the Study:

  • To determine the available energy of soluble fiber products, specifically PROMITOR® Soluble Corn Fiber 70 (SCF70) and PROMITOR® Soluble Corn Fiber 85B (SCF85B).
  • To quantify the energy contribution of these fibers for food industry applications.
  • To establish a reliable caloric value for soluble corn fiber ingredients.

Main Methods:

  • A randomized, double-blind, crossover human study involving 19 healthy adults (18-34 years).
  • Breath hydrogen levels were measured after consumption of beverages containing inulin (control), SCF70, or SCF85B at varying doses (5, 10, 15g).
  • Available energy was calculated using inulin as a reference, based on breath hydrogen response (incremental area under the curve over 10 hours).

Main Results:

  • Breath hydrogen production was significantly lower for SCF70 and SCF85B compared to inulin across all doses.
  • No significant differences in breath hydrogen production were observed between SCF70 and SCF85B.
  • This indicates comparable fermentation and energy release from both soluble corn fiber products.

Conclusions:

  • The available energy per gram of fiber was not significantly different between SCF70 and SCF85B.
  • The available energy of the fiber component in PROMITOR® Soluble Corn Fiber products was determined to be 0.2 kcal/gram.
  • This finding provides precise caloric data for PROMITOR® SCF products, supporting accurate food labeling and formulation.