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Completed

NCT Number: NCT05430061

Crossover Trials Which Assessed Consumption of Slowly Digestible Carbohydrates for 21 Days on Gastric Emptying Rates

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).

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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • normal body mass index (18.5 kg/m² < BMI < 25)
  • healthy eating index score (<65)

Exclusion criteria

  • gastrointestinal and cardiovascular disease
  • food allergies or intolerances
  • pregnancy
  • smokers

Treatment and study plan

slowly digestible carbohydrate

Dietary Supplement

carbohydrates with slow digestion rate have the capacity to induce slow gastric emptying time and potentially modify metabolic response and modulate postprandial glycemia.

Primary outcomes

  1. Gastric half emptying time

    Time frame: 21 days of intervention

    Using a 13C octanoic acid breath test we assessed gastric emptying time using a non-invasive procedure

Secondary outcomes

  1. Respiratory exchange ratio and metabolic flexibility

    Time frame: 21 days of intervention

    Using a portable, handheld device we assessed CO2 production after a consumption of a standardized meal. This device helped used determine RER and subsequent metabolic flexibility.

  2. Height and Weight

    Time frame: Height and weight will only be entered at baseline.

    Height (in cm) and Weight (in Kg) will not be individually collected and will not be an outcome in the study. However, height and weight will be used by the algorithm using by the device (Lumen) to calculate RER. We do not expect to see changes in weight during the intervention.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Official study title

Impact of Slowly Digestible Carbohydrates on Gastric Emptying Rates

Acronym: INT

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2022
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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