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

NCT05430061 | Completed

• 1 other identifier: 1706019377
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obesity; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Respiratory exchange ratio and metabolic flexibility

  21 days of intervention

• Height and Weight

  Height and weight will only be entered at baseline.

Study Arms (2)

Raw corn starch

EXPERIMENTAL

Raw corn starch is a slow digesting carbohydrate, 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. Participants will receive 21 individual containers of raw corn starch (30 g/container) and 21 cups of 4 oz unsweetened apple sauce. Participants will be asked to consume one starch container mixed in apple sauce at 10 a.m.; each day for 21 days.

Dietary Supplement: slowly digestible carbohydrate

Maltodextrin DE-10

SHAM COMPARATOR

Maltodextrin dextrose equivalent 10 is a fast digesting carbohydrate, 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. Participants will receive 21 individual containers of maltodextrin (30 g/container) and 21 cups of 4 oz unsweetened apple sauce. Participants will be asked to consume one maltodextrin container mixed in apple sauce at 10 a.m.; each day for 21 days.

Dietary Supplement: slowly digestible carbohydrate

Interventions

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.

Maltodextrin DE-10; Raw corn starch

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47906, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Bruce R Hamaker, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not aware of the treatment recieved
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / Distinguished professor

Model Details: treatment (21 days of consumption of 30 g of raw corn starch) and control (21 days of consumption of maltodextrin)

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: June 24, 2022
• Study Start: July 27, 2017
• Primary Completion: October 23, 2021
• Study Completion: December 1, 2021
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)