Digestive Properties of Carbohydrate-based Foods

Not Applicable

Completed

• Conditions: Appetitive Behavior; Obesity; Diabetes Mellitus, Type 2
• Interventions: Other: Wheat couscous; Other: Pearl millet couscous - made in Senegal; Other: White rice; Other: Pearl millet thick porridge; Other: Pearl millet couscous - made in USA

• Registration Number: NCT03630458
• Lead Sponsor: Purdue University

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.

Study Timeline

• Study Start: 2018-06-11
• Study First Submitted: 2018-06-27
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Wheat couscous	Wheat couscous	Steamed wheat couscous - wheat flour processed and prepared in USA
Pearl millet couscous - made in Senegal	Pearl millet couscous - made in Senegal	Steamed pearl millet couscous - commercially produced in Senegal
White rice	White rice	White rice - medium-grain prepared using a rice cooker
Pearl millet thick porridge	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
Pearl millet couscous - made in USA	Pearl millet couscous - made in USA	Steamed pearl millet couscous - pearl millet obtained from Senegal but processed and prepared in USA

Primary Outcome Measures

Name	Time	Method
Glycemic response	Acute study; 4 hours of measurement after consumption of test food	Blood glucose is being measured using continuous glucose monitors.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States