Digestion of Foods Consumed in Africa

Study Overview
=================
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.

Official Title
-----------------
Assessment of Gastric Emptying and Fullness of Different Types of Foods in Mali

Conditions
-----------------
Obesity and Other Hyperalimentation

Intervention / Treatment
-----------------
* Other: Rice
* Other: Potato
* Other: Pasta
* Other: Sorghum thick porridge
* Other: Millet thick porridge
* Other: Millet couscous
* Other: Millet thin porridge
* Other: Millet thin monikuru porridge


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rice<br>Cooked white rice and tomato-based sauce | Other: Rice<br>* Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.<br>|
| Experimental: Potato<br>Cooked white peeled potato and tomato-based sauce | Other: Potato<br>* Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response .<br>|
| Experimental: Pasta<br>Cooked macaroni product and tomato-based sauce | Other: Pasta<br>* Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.<br>|
| Experimental: Sorghum thick porridge<br>Sorghum thick porridge and tomato-based sauce | Other: Sorghum thick porridge<br>* Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.<br>|
| Experimental: Millet thick porridge<br>Millet thick porridge and tomato-based sauce | Other: Millet thick porridge<br>* Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.<br>|
| Experimental: Millet couscous<br>Cooked millet couscous and tomato-based sauce | Other: Millet couscous<br>* Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.<br>|
| Experimental: Millet thin porridge<br>Millet thin porridge | Other: Millet thin porridge<br>* Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.<br>|
| Experimental: Millet thin monikuru porridge<br>Millet thin porridge containing cooked millet granules (monikuru) | Other: Millet thin monikuru porridge<br>* Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying | Breath test was performed using 13C-octanoic acid mixed into test meals | acute study, 4 hours after consumption of test food | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetitive response | Fullness and hunger questionnaire was given at various time points after consumption of test foods | acute study, 4 hours after consumption of test food |