Digestive Properties of Carbohydrate-based Foods

Obesity Clinical Trial

Official title:

Investigating Digestive Properties of Carbohydrate-based Foods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630458
• Other study ID #: 1706019348
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2019
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior
• Diabetes Mellitus, Type 2
• Obesity

Intervention

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.
• Pearl millet couscous - made in USA
Pearl millet couscous (made in USA) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
• Pearl millet thick porridge
Pearl millet thick porridge was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
• Wheat couscous
Wheat couscous was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
• White rice
White rice was tested as a comparator for gastric emptying rate, glycemic response, fermentability, and appetitive response.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying rate	Breath test is being performed using 13C-octanoic acid mixed into test meals.	Acute study; 4 hours of measurement after consumption of test food
Primary	Glycemic response	Blood glucose is being measured using continuous glucose monitors.	Acute study; 4 hours of measurement after consumption of test food
Secondary	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.	Acute study; 4 hours of measurement after consumption of test food
Secondary	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.	Acute study; 4 hours of measurement after consumption of test food