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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
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 27, 2018
Last Updated
August 21, 2019
Sponsor
Purdue University
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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.

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Digestive Properties of Carbohydrate-based Foods

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