NCT03630458

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

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

June 11, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

June 27, 2018

Last Update Submit

August 21, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Gastric emptying rate

    Breath test is being performed using 13C-octanoic acid mixed into test meals.

    Acute study; 4 hours of measurement after consumption of test food

  • Glycemic response

    Blood glucose is being measured using continuous glucose monitors.

    Acute study; 4 hours of measurement after consumption of test food

Secondary Outcomes (2)

  • Breath hydrogen (fermentability)

    Acute study; 4 hours of measurement after consumption of test food

  • Appetitive response

    Acute study; 4 hours of measurement after consumption of test food

Study Arms (5)

Pearl millet couscous - made in Senegal

EXPERIMENTAL

Steamed pearl millet couscous - commercially produced in Senegal

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

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

Other: Pearl millet thick porridge

Wheat couscous

EXPERIMENTAL

Steamed wheat couscous - wheat flour processed and prepared in USA

Other: Wheat couscous

White rice

ACTIVE COMPARATOR

White rice - medium-grain prepared using a rice cooker

Other: White rice

Interventions

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

Pearl millet couscous - made in Senegal

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

Pearl millet couscous - made in USA

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

Pearl millet thick porridge

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

Wheat couscous

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

White rice

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal body mass index (18.5 \< BMI \< 25 kg/m2)
  • Normal fasting blood glucose

You may not qualify if:

  • Diabetes
  • Allergy to millet
  • Allergy or sensitivity/intolerance to gluten
  • History of gastrointestinal disease
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Appetitive Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehavior, AnimalBehavior

Study Design

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

Study Record Dates

First Submitted

June 27, 2018

First Posted

August 14, 2018

Study Start

June 11, 2018

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

August 22, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available to other researchers.

Locations