ObesityNCT03630458
Digestive Properties of Carbohydrate-based Foods
A study testing Pearl millet couscous - made in Senegal, Pearl millet couscous - made in USA and Pearl millet thick porridge in people with Obesity and Diabetes Mellitus, Type 2, run by Purdue University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
- What is being tested?
- Pearl millet couscous - made in Senegal, Pearl millet couscous - made in USA and Pearl millet thick porridge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2018to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal body mass index (18.5 < BMI < 25 kg/m2)
- Normal fasting blood glucose
Who cannot join
- Diabetes
- Allergy to millet
- Allergy or sensitivity/intolerance to gluten
- History of gastrointestinal disease
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating 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).
Read the detailed 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.
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
- Being tested
- Pearl millet couscous - made in Senegal, Pearl millet couscous - made in USA, Pearl millet thick porridge, Wheat couscous, White rice
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pearl millet couscous - made in SenegalOther
Pearl millet couscous (made in Senegal) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Pearl millet couscous - made in USAOther
Pearl millet couscous (made in USA) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Pearl millet thick porridgeOther
Pearl millet thick porridge was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Wheat couscousOther
Wheat couscous was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
White riceOther
White rice was tested as a comparator for gastric emptying rate, glycemic response, fermentability, and appetitive response.
| Study group | Role | What they receive |
|---|---|---|
| Pearl millet couscous - made in Senegal | Experimental | Steamed pearl millet couscous - commercially produced in Senegal Receives: Other: Pearl millet couscous - made in Senegal |
| Pearl millet couscous - made in USA | Experimental | Steamed pearl millet couscous - pearl millet obtained from Senegal but processed and prepared in USA Receives: Other: Pearl millet couscous - made in USA |
| Pearl millet thick porridge | Experimental | Thick porridge prepared according to traditional West African methods with pearl millet obtained from Senegal but processed and prepared in USA Receives: Other: Pearl millet thick porridge |
| Wheat couscous | Experimental | Steamed wheat couscous - wheat flour processed and prepared in USA Receives: Other: Wheat couscous |
| White rice | Active comparator | White rice - medium-grain prepared using a rice cooker Receives: Other: White rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying rate
Breath test is being performed using 13C-octanoic acid mixed into test meals.
Measured: Acute study; 4 hours of measurement after consumption of test food
Glycemic response
Blood glucose is being measured using continuous glucose monitors.
Measured: Acute study; 4 hours of measurement after consumption of test food
Secondary outcomes (2)
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.
Measured: Acute study; 4 hours of measurement after consumption of test food
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.
Measured: Acute study; 4 hours of measurement after consumption of test food
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start11 Jun 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce R. Hamaker, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630458
- Sponsor's protocol ID
- 1706019348
- Status last verified
- Aug 2019
- First submitted
- 27 Jun 2018
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Digestive Properties of Carbohydrate-based Foods
- ClinicalTrials.gov ID
- NCT03630458
- Acronym / sponsor ID
- 1706019348
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pearl millet couscous - made in Senegal | Experimental | Other: Pearl millet couscous - made in SenegalSteamed pearl millet couscous - commercially produced in Senegal |
| Pearl millet couscous - made in USA | Experimental | Other: Pearl millet couscous - made in USASteamed pearl millet couscous - pearl millet obtained from Senegal but processed and prepared in USA |
| Pearl millet thick porridge | Experimental | Other: Pearl millet thick porridgeThick porridge prepared according to traditional West African methods with pearl millet obtained from Senegal but processed and prepared in USA |
| Wheat couscous | Experimental | Other: Wheat couscousSteamed wheat couscous - wheat flour processed and prepared in USA |
| White rice | Active comparator | Other: White riceWhite rice - medium-grain prepared using a rice cooker |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal body mass index (18.5 < BMI < 25 kg/m2)
- Normal fasting blood glucose
Key exclusion criteria (5 listed)
- Diabetes
- Allergy to millet
- Allergy or sensitivity/intolerance to gluten
- History of gastrointestinal disease
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pearl millet couscous - made in SenegalPearl millet couscous (made in Senegal) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response. | Other | Pearl millet couscous - made in Senegal |
| Pearl millet couscous - made in USAPearl millet couscous (made in USA) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response. | Other | Pearl millet couscous - made in USA |
| Pearl millet thick porridgePearl millet thick porridge was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response. | Other | Pearl millet thick porridge |
| Wheat couscousWheat couscous was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response. | Other | Wheat couscous |
| White riceWhite rice was tested as a comparator for gastric emptying rate, glycemic response, fermentability, and appetitive response. | Other | White rice |
Primary outcome
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.
Glycemic response
Time frame: Acute study; 4 hours of measurement after consumption of test food
Blood glucose is being measured using continuous glucose monitors.
2 secondary outcomes
Breath hydrogen (fermentability)
Time frame: Acute study; 4 hours of measurement after consumption of test food
Appetitive response
Time frame: Acute study; 4 hours of measurement after consumption of test food
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pearl millet couscous - made in Senegal, Pearl millet couscous - made in USA and Pearl millet thick porridge in people with Obesity and Diabetes Mellitus, Type 2, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying rate (time frame: Acute study; 4 hours of measurement after consumption of test food). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.