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Completed

NCT Number: NCT03630458

Digestive Properties of Carbohydrate-based Foods

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).

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Key information

Conditions

Obesity Appetitive Behavior Behavior Behavior, Animal Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pearl millet couscous - made in Senegal

Other

Pearl millet couscous (made in Senegal) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.

Pearl millet couscous - made in USA

Other

Pearl millet couscous (made in USA) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.

Pearl millet thick porridge

Other

Pearl millet thick porridge was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.

Wheat couscous

Other

Wheat couscous was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.

White Rice

Other

White rice was tested as a comparator for gastric emptying rate, glycemic response, fermentability, and appetitive response.

Primary outcomes

  1. Gastric emptying rate

    Time frame: 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

    Time frame: Acute study; 4 hours of measurement after consumption of test food

    Blood glucose is being measured using continuous glucose monitors.

Secondary outcomes

  1. Breath hydrogen (fermentability)

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Official study title

Investigating Digestive Properties of Carbohydrate-based Foods

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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