Digestive Properties of Carbohydrate-based Foods
Primary Purpose
Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pearl millet couscous - made in Senegal
Pearl millet couscous - made in USA
Pearl millet thick porridge
Wheat couscous
White rice
Sponsored by
About this trial
This is an interventional other trial for Obesity
Eligibility 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
Sites / Locations
- Purdue University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Pearl millet couscous - made in Senegal
Pearl millet couscous - made in USA
Pearl millet thick porridge
Wheat couscous
White rice
Arm Description
Steamed pearl millet couscous - commercially produced in Senegal
Steamed pearl millet couscous - pearl millet obtained from Senegal but processed and prepared in USA
Thick porridge prepared according to traditional West African methods with pearl millet obtained from Senegal but processed and prepared in USA
Steamed wheat couscous - wheat flour processed and prepared in USA
White rice - medium-grain prepared using a rice cooker
Outcomes
Primary Outcome Measures
Gastric emptying rate
Breath test is being performed using 13C-octanoic acid mixed into test meals.
Glycemic response
Blood glucose is being measured using continuous glucose monitors.
Secondary Outcome Measures
Breath hydrogen (fermentability)
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.
Appetitive response
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03630458
Brief Title
Digestive Properties of Carbohydrate-based Foods
Official Title
Investigating Digestive Properties of Carbohydrate-based Foods
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pearl millet couscous - made in Senegal
Arm Type
Experimental
Arm Description
Steamed pearl millet couscous - commercially produced in Senegal
Arm Title
Pearl millet couscous - made in USA
Arm Type
Experimental
Arm Description
Steamed pearl millet couscous - pearl millet obtained from Senegal but processed and prepared in USA
Arm Title
Pearl millet thick porridge
Arm Type
Experimental
Arm Description
Thick porridge prepared according to traditional West African methods with pearl millet obtained from Senegal but processed and prepared in USA
Arm Title
Wheat couscous
Arm Type
Experimental
Arm Description
Steamed wheat couscous - wheat flour processed and prepared in USA
Arm Title
White rice
Arm Type
Active Comparator
Arm Description
White rice - medium-grain prepared using a rice cooker
Intervention Type
Other
Intervention Name(s)
Pearl millet couscous - made in Senegal
Intervention Description
Pearl millet couscous (made in Senegal) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Intervention Type
Other
Intervention Name(s)
Pearl millet couscous - made in USA
Intervention Description
Pearl millet couscous (made in USA) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Intervention Type
Other
Intervention Name(s)
Pearl millet thick porridge
Intervention Description
Pearl millet thick porridge was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Intervention Type
Other
Intervention Name(s)
Wheat couscous
Intervention Description
Wheat couscous was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Intervention Type
Other
Intervention Name(s)
White rice
Intervention Description
White rice was tested as a comparator for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Primary Outcome Measure Information:
Title
Gastric emptying rate
Description
Breath test is being performed using 13C-octanoic acid mixed into test meals.
Time Frame
Acute study; 4 hours of measurement after consumption of test food
Title
Glycemic response
Description
Blood glucose is being measured using continuous glucose monitors.
Time Frame
Acute study; 4 hours of measurement after consumption of test food
Secondary Outcome Measure Information:
Title
Breath hydrogen (fermentability)
Description
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.
Time Frame
Acute study; 4 hours of measurement after consumption of test food
Title
Appetitive response
Description
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.
Time Frame
Acute study; 4 hours of measurement after consumption of test food
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be made available to other researchers.
Learn more about this trial
Digestive Properties of Carbohydrate-based Foods
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