Clinical trial NCT03007368: Digestion of Foods Consumed in Africa
Official title: Assessment of Gastric Emptying and Fullness of Different Types of Foods in Mali
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity and Other Hyperalimentation
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
First posted: 2017-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: As populations become urbanized in Africa, the change to a more Westernized diet has been associated with rise in obesity and related metabolic syndrome diseases. The current study shows that in the West African Sahel, these replacement starchy staple foods have fast gastric emptying compared to traditional sorghum and millet foods; and implies that the latter could be beneficial in lowering glycemic response, providing energy from a meal over a longer time, and providing a satiety effect. Knowledge of this attribute of sorghum and millet foods could be useful to improve their image in West African cities to increase their consumption and to improve markets for local smallholder farmers.

Detailed description: As suggested by anecdotal evidence that traditional Malian sorghum and millet foods are filling and provide sustained energy, we hypothesized that gastric emptying rates of sorghum and millet foods are slow, particularly compared to non-traditional starchy foods (white rice, potato, wheat pasta) that are now commonly consumed in urban areas of the West African Sahel. A broader purpose for the study was to understand whether sorghum and millet foods have positive health attributes that can be promoted in urban areas to provide better markets for local farmers.

Two human trials of similar design were conducted approximately one year apart. The carbon 13 (13C)-labelled octanoic acid breath test method was used to measure gastric emptying rate, and subjective pre-test and satiety response questionnaires were used. In the first study, 14 healthy volunteers in Bamako, Mali participated in a crossover design to test eight starchy foods for gastric emptying rate and satiety feelings. The second study with six volunteers was done to correct for endogenous 13C differences in the starch component of the foods.

Eligibility criteria: Inclusion Criteria:

* Normal body mass index (18 kg/m2 ≤ BMI ≤ 25 kg/m2)

Exclusion Criteria:

* Under any medication
* History of any gastrointestinal disease or surgery
* Diabetes
* Smoker

Primary outcomes:
measure: Gastric emptying
timeFrame: acute study, 4 hours after consumption of test food
Secondary outcomes:
measure: Appetitive response
timeFrame: acute study, 4 hours after consumption of test food
Other outcomes:
Locations:
Study officials:
References:
citation: Ghoos YF, Maes BD, Geypens BJ, Mys G, Hiele MI, Rutgeerts PJ, Vantrappen G. Measurement of gastric emptying rate of solids by means of a carbon-labeled octanoic acid breath test. Gastroenterology. 1993 Jun;104(6):1640-7. doi: 10.1016/0016-5085(93)90640-x.
citation: Choi MG, Camilleri M, Burton DD, Zinsmeister AR, Forstrom LA, Nair KS. [13C]octanoic acid breath test for gastric emptying of solids: accuracy, reproducibility, and comparison with scintigraphy. Gastroenterology. 1997 Apr;112(4):1155-62. doi: 10.1016/s0016-5085(97)70126-4.
citation: Clegg ME, Shafat A. Procedures in the 13C octanoic acid breath test for measurement of gastric emptying: analysis using Bland-Altman methods. Scand J Gastroenterol. 2010 Aug;45(7-8):852-61. doi: 10.3109/00365521.2010.483740.
citation: Schoeller DA, Klein PD, Watkins JB, Heim T, MacLean WC Jr. 13C abundances of nutrients and the effect of variations in 13C isotopic abundances of test meals formulated for 13CO2 breath tests. Am J Clin Nutr. 1980 Nov;33(11):2375-85. doi: 10.1093/ajcn/33.11.2375.