Digestive Properties of Carbohydrate-based Foods

August 21, 2019 updated by: Bruce R. Hamaker, Purdue University

Investigating Digestive Properties of Carbohydrate-based Foods

Gastric emptying rate, glycemic response, fermentation, and appetitive response are being assessed after consumption of traditional West African carbohydrate-based foods (pearl millet couscous, pearl millet thick porridge) and Western type carbohydrate-based foods (wheat couscous, white rice).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anecdotal evidence suggests that couscous made from pearl millet (Pennisetum glaucum), hereby referred to as millet couscous, is highly satiating in populations living in the West African Sahel. Results from a previous human study conducted the investigators indicated that traditional West African foods made from pearl millet and sorghum (millet couscous, millet thick porridge, and sorghum thick porridge) exhibit markedly delayed rates of gastric emptying compared to Western foods (pasta, boiled potatoes, and white rice) in a population from Mali, Africa. The delayed gastric emptying rate of the thick porridges can be attributed at least partially to the impact of viscosity, while the cause of the delayed gastric emptying rate of the millet couscous remains unclear. The overall aim of this research is to determine why millet couscous exhibits a delayed rate of gastric emptying, while also assessing other digestive properties to gain a better understanding of the factors that could be contributing to this outcome. Therefore, gastric emptying rate, glycemic response, fermentation, and appetitive response are all being assessed for West African and Western foods in a population residing in the United States.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal body mass index (18.5 < BMI < 25 kg/m2)
  • Normal fasting blood glucose

Exclusion Criteria:

  • Diabetes
  • Allergy to millet
  • Allergy or sensitivity/intolerance to gluten
  • History of gastrointestinal disease
  • Pregnant or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pearl millet couscous - made in Senegal
Steamed pearl millet couscous - commercially produced in Senegal
Other: Pearl millet couscous - made in Senegal
Pearl millet couscous (made in Senegal) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Experimental: Pearl millet couscous - made in USA
Steamed pearl millet couscous - pearl millet obtained from Senegal but processed and prepared in USA
Other: Pearl millet couscous - made in USA
Pearl millet couscous (made in USA) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Experimental: Pearl millet thick porridge
Thick porridge prepared according to traditional West African methods with pearl millet obtained from Senegal but processed and prepared in USA
Other: Pearl millet thick porridge
Pearl millet thick porridge was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Experimental: Wheat couscous
Steamed wheat couscous - wheat flour processed and prepared in USA
Other: Wheat couscous
Wheat couscous was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Active Comparator: White rice
White rice - medium-grain prepared using a rice cooker
Other: White rice
White rice was tested as a comparator for gastric emptying rate, glycemic response, fermentability, and appetitive response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric emptying rate
Time Frame: Acute study; 4 hours of measurement after consumption of test food
Breath test is being performed using 13C-octanoic acid mixed into test meals.
Acute study; 4 hours of measurement after consumption of test food
Glycemic response
Time Frame: Acute study; 4 hours of measurement after consumption of test food
Blood glucose is being measured using continuous glucose monitors.
Acute study; 4 hours of measurement after consumption of test food

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath hydrogen (fermentability)
Time Frame: Acute study; 4 hours of measurement after consumption of test food
Breath samples are being collected at certain intervals for 4 hours after consumption of test food and analyzed for hydrogen levels using a breath analyzer. Breath hydrogen levels are indicative of a food's fermentability.
Acute study; 4 hours of measurement after consumption of test food
Appetitive response
Time Frame: Acute study; 4 hours of measurement after consumption of test food
Hunger and fullness scores are being measured using a 10-cm scale (0 = weakest feeling of hunger or fullness and 10 = strongest feeling of hunger or fullness) after consumption of test food. Weaker feelings of hunger and stronger feelings of fullness are indicative of better outcomes.
Acute study; 4 hours of measurement after consumption of test food

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2018

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

June 27, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1706019348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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