At a glance
ClinicalIndex Comparison RecordN/AActive· 65 enrolled
Drug / intervention
Whole Wheat Bread +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components
In Brief
A clinical study evaluating Whole Wheat Bread and White Bread (control) for PreDiabetes and 3 related conditions. Active but no longer recruiting, targeting 65 participants across 1 site.
Detailed Summary
This study will investigate the gut microbiota-mediated effects of whole wheat consumption on human health in adults with pre-diabetes. Participants will complete two phases of intervention in random order in which they will consume either whole wheat bread (4 servings) or white bread a day for two weeks prior to collecting specimens (stool, urine, and plasma/serum).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreDiabetes, Dysbiosis, Endotoxemia, Inflammation
CountriesUnited States
CollaboratorsUnited States Department of Agriculture (USDA)
Timeline
N/AActiveOverdue
20222023202420252026
Enrollment StartJan 2022
First PostedApr 2022
Primary CompletionMay 2024
Study CompletionMay 2026
TodayJul 2026
First PostedApr 8, 2022
Enrollment StartJan 27, 2022
Primary CompletionMay 30, 2024
Study CompletionMay 30, 2026
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.2 years ago
Interventions
Whole Wheat Breadother
Standardized whole wheat bread (128 g daily)
White Bread (control)other
Standardized white bread (128 g daily)