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

Obesity Clinical Trial

— INT  

Official title:

Impact of Slowly Digestible Carbohydrates on Gastric Emptying Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05430061
• Other study ID #: 1706019377
• Status: Completed
• Phase: N/A
• Start date: July 27, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2022
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 1, 2021
• Est. primary completion date: October 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Dietary Supplement:
• slowly digestible carbohydrate
carbohydrates with slow digestion rate have the capacity to induce slow gastric emptying time and potentially modify metabolic response and modulate postprandial glycemia.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric half emptying time	Using a 13C octanoic acid breath test we assessed gastric emptying time using a non-invasive procedure	21 days of intervention
Secondary	Respiratory exchange ratio and metabolic flexibility	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.	21 days of intervention
Secondary	Height and Weight	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.	Height and weight will only be entered at baseline.