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Digestive Properties of Carbohydrate-based Foods

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ClinicalTrials.gov Identifier: NCT03630458
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Bruce R. Hamaker, Purdue University

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Obesity Diabetes Mellitus, Type 2 Appetitive Behavior Other: Pearl millet couscous - made in Senegal Other: Pearl millet couscous - made in USA Other: Pearl millet thick porridge Other: Wheat couscous Other: White rice Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigating Digestive Properties of Carbohydrate-based Foods
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Glycemic response [ Time Frame: Acute study; 4 hours of measurement after consumption of test food ]
    Blood glucose is being measured using continuous glucose monitors.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630458


Locations
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United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
More Information
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Responsible Party: Bruce R. Hamaker, Distinguished Professor of Food Science, Purdue University
ClinicalTrials.gov Identifier: NCT03630458    
Other Study ID Numbers: 1706019348
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases