Crossover Trials Which Assessed Consumption of Slowly Digestible Carbohydrates for 21 Days on Gastric Emptying Rates
Condition: Obesity; Diabetes
Study type: Interventional

Summary: 
      To gain a better understanding about the conditioning effect of consumption of slowly
      digestible carbohydrate on gastric emptying rate, respiratory quotient and metabolic
      flexibility, this study will focus on monitoring change in gastric emptying with consumption
      of a single source of slowly digestible carbohydrate (30 g of raw corn starch) for 21 days
      and compared to a control (21 days of continious consumption of rapidly digesting
      carbohydrate maltodextrin).
    

Detailed description: 
      Corn starch, a commonly consumed food ingredient, considered GRAS (generally recognized as
      safe) CFR 182.70- 182.90 will be used as the test meal treatment fed to non-responding
      subjects (rapid gastric emptying rate after consumption of slowly digestible carbohydrate)
      for 1 month. Corn starch will be mixed with applesauce (200 g) and a small amount of xanthan
      gum (amount to be determined) (GRAS # 121) for palatability and viscosity, respectively.

      In order to determine whether potential changes in gastric emptying time are induced by
      consumption of slowly digestible carbohydrates, a control group will be used. The control
      group will consume a meal composed applesauce (200 g) and xanthan gum with a fast digesting
      carbohydrate (30 g DE -1 maltodextrinpregelatinized starch). The product is commercially
      available and will be provided by Tate and Lyle under the brand name of Star-Dri 1. The
      general term "maltodextrin" is a non-sweet nutritive polymer that consists of D-glucose units
      linked primarily by [alpha]-1-4 bonds and that has a dextrose equivalent (D.E.) of less than
      20. It is regarded as Generally Recognized as Safe (GRAS) by the U.S. Food and Drug
      Administration for direct use as a food ingredient (GRAS, 21CFR184.1444).DE-1 Maltodextrin is
      commercially available and will be provided by Tate and Lyle under the brand name of Star-Dri
      1. Maltodextrin is a non-sweet nutritive saccharide polymer that consists of D-glucose units
      linked primarily by [alpha]-1-4 bonds and that has a dextrose equivalent (D.E.) of less than
      20. It is regarded as Generally Recognized as Safe (GRAS) by the Food and Drug Administration
      for direct use as a food ingredient (GRAS, 21CFR184.1444). Ultimately, this study will help
      elucidate attributes of carbohydrate-based foods that can promote slow digestion and create a
      satiety feeling and promote weight management, which can then be implemented to develop foods
      with superior health benefits.
    

Intervention name(s): slowly digestible carbohydrate
Intervention type(s): Dietary Supplement
Intervention description(s): carbohydrates with slow digestion rate have the capacity to induce slow gastric emptying time and potentially modify metabolic response and modulate postprandial glycemia.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: treatment (21 days of consumption of 30 g of raw corn starch) and control (21 days of consumption of maltodextrin)
Masking: Single (Participant)
Primary purpose: Prevention