NCT03007368

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

1.1 years

First QC Date

November 1, 2016

Last Update Submit

December 29, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying

    Breath test was performed using 13C-octanoic acid mixed into test meals

    acute study, 4 hours after consumption of test food

Secondary Outcomes (1)

  • Appetitive response

    acute study, 4 hours after consumption of test food

Study Arms (8)

Rice

EXPERIMENTAL

Cooked white rice and tomato-based sauce

Other: Rice

Potato

EXPERIMENTAL

Cooked white peeled potato and tomato-based sauce

Other: Potato

Pasta

EXPERIMENTAL

Cooked macaroni product and tomato-based sauce

Other: Pasta

Sorghum thick porridge

EXPERIMENTAL

Sorghum thick porridge and tomato-based sauce

Other: Sorghum thick porridge

Millet thick porridge

EXPERIMENTAL

Millet thick porridge and tomato-based sauce

Other: Millet thick porridge

Millet couscous

EXPERIMENTAL

Cooked millet couscous and tomato-based sauce

Other: Millet couscous

Millet thin porridge

EXPERIMENTAL

Millet thin porridge

Other: Millet thin porridge

Millet thin monikuru porridge

EXPERIMENTAL

Millet thin porridge containing cooked millet granules (monikuru)

Other: Millet thin monikuru porridge

Interventions

RiceOTHER

Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.

Rice
PotatoOTHER

Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response .

Potato
PastaOTHER

Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.

Pasta

Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.

Sorghum thick porridge

Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.

Millet thick porridge

Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.

Millet couscous

Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.

Millet thin porridge

Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.

Millet thin monikuru porridge

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 8500721BACKGROUND
  • 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.

    PMID: 9097998BACKGROUND
  • 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.

    PMID: 20443742BACKGROUND
  • 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.

    PMID: 6776794BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 1, 2016

First Posted

January 2, 2017

Study Start

March 1, 2012

Primary Completion

April 1, 2013

Study Completion

May 1, 2013

Last Updated

January 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Not shared