Digestive Properties of Carbohydrate-based Foods

Sponsor
Purdue University (Other)
Overall Status
Completed
CT.gov ID
NCT03630458
Collaborator
(none)
15
1
5
1.6
9.1

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

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

Study Type:
Interventional
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 :
Jun 11, 2018
Actual Primary Completion Date :
Jul 31, 2018
Actual Study Completion Date :
Jul 31, 2018

Arms and Interventions

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

Primary Outcome Measures

  1. Gastric emptying rate [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 [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) [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 [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

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Purdue University West Lafayette Indiana United States 47907

Sponsors and Collaborators

  • Purdue University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bruce R. Hamaker, Distinguished Professor of Food Science, Purdue University
ClinicalTrials.gov Identifier:
NCT03630458
Other Study ID Numbers:
  • 1706019348
First Posted:
Aug 14, 2018
Last Update Posted:
Aug 22, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2019