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Trial Outcomes & Findings for Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components (NCT NCT05318183)

NCT ID: NCT05318183

Last Updated: 2025-11-20

Results Overview

Data are biomarker area under the time-concentration curve (0-3 hours) on day 14

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

65 participants

Primary outcome timeframe

Day 14 (0, 30, 60, 90, 120, 150, 180 minutes post oral glucose tolerance test)

Results posted on

2025-11-20

Participant Flow

Participant milestones

Participant milestones
Measure
Whole Wheat Bread, Then White Bread
Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks, followed by a 2-week washout period, then consumed white bread daily for 2 weeks. Whole Wheat Bread: Standardized whole wheat bread (128 g daily)
White Bread (Control), Then Whole Wheat Bread
Participants consumed 128 g of white bread (4 slices of bread) daily for two weeks, followed by a 2-week washout period, and then consumed whole wheat bread daily for an additional 2 weeks. White Bread (control): Standardized white bread (128 g daily)
First Intervention (2 Weeks)
STARTED
25
24
First Intervention (2 Weeks)
COMPLETED
21
21
First Intervention (2 Weeks)
NOT COMPLETED
4
3
Washout (2 Weeks)
STARTED
21
21
Washout (2 Weeks)
COMPLETED
21
21
Washout (2 Weeks)
NOT COMPLETED
0
0
Second Intervention (2 Weeks)
STARTED
21
21
Second Intervention (2 Weeks)
COMPLETED
21
18
Second Intervention (2 Weeks)
NOT COMPLETED
0
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Whole Wheat Bread, Then White Bread
Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks, followed by a 2-week washout period, then consumed white bread daily for 2 weeks. Whole Wheat Bread: Standardized whole wheat bread (128 g daily)
White Bread (Control), Then Whole Wheat Bread
Participants consumed 128 g of white bread (4 slices of bread) daily for two weeks, followed by a 2-week washout period, and then consumed whole wheat bread daily for an additional 2 weeks. White Bread (control): Standardized white bread (128 g daily)
First Intervention (2 Weeks)
Withdrawal by Subject
2
3
First Intervention (2 Weeks)
Lost to Follow-up
2
0
Second Intervention (2 Weeks)
Protocol Violation
0
2
Second Intervention (2 Weeks)
Withdrawal by Subject
0
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=39 Participants
Baseline characteristics of participants at screening
Age, Categorical
<=18 years
0 Participants
n=39 Participants
Age, Categorical
Between 18 and 65 years
39 Participants
n=39 Participants
Age, Categorical
>=65 years
0 Participants
n=39 Participants
Sex: Female, Male
Female
18 Participants
n=39 Participants
Sex: Female, Male
Male
21 Participants
n=39 Participants
Region of Enrollment
United States
39 participants
n=39 Participants
BMI
34.7 kg/m^2
STANDARD_DEVIATION 5.2 • n=39 Participants
Fasting plasma glucose
108.7 mg/dL
STANDARD_DEVIATION 6.3 • n=39 Participants
Systolic blood pressure
122.6 mmHg
STANDARD_DEVIATION 10.3 • n=39 Participants
Diastolic blood pressure
81.9 mmHg
STANDARD_DEVIATION 7.5 • n=39 Participants
Waist circumference
106.1 cm
STANDARD_DEVIATION 12.3 • n=39 Participants

PRIMARY outcome

Timeframe: Day 14 (0, 30, 60, 90, 120, 150, 180 minutes post oral glucose tolerance test)

Data are biomarker area under the time-concentration curve (0-3 hours) on day 14

Outcome measures

Outcome measures
Measure
White Bread (Control)
n=39 Participants
Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks White Bread (control): Standardized white bread (128 g daily)
Whole Wheat Bread
n=39 Participants
Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks Whole Wheat Bread: Standardized whole wheat bread (128 g daily)
Plasma Glucose
5622.96 mg/dL x min
Standard Error 644.59
4092.15 mg/dL x min
Standard Error 597.81

SECONDARY outcome

Timeframe: Day 14

Data are biomarker fasting concentrations

Outcome measures

Outcome measures
Measure
White Bread (Control)
n=39 Participants
Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks White Bread (control): Standardized white bread (128 g daily)
Whole Wheat Bread
n=39 Participants
Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks Whole Wheat Bread: Standardized whole wheat bread (128 g daily)
Plasma Insulin
16.0 uIU/mL
Standard Error 1.6
18.9 uIU/mL
Standard Error 2.8

SECONDARY outcome

Timeframe: Day 14

Data are biomarker fasting concentrations.

Outcome measures

Outcome measures
Measure
White Bread (Control)
n=39 Participants
Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks White Bread (control): Standardized white bread (128 g daily)
Whole Wheat Bread
n=39 Participants
Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks Whole Wheat Bread: Standardized whole wheat bread (128 g daily)
Plasma Glucose
85.6 mg/dL
Standard Error 2.3
93.5 mg/dL
Standard Error 2.6

SECONDARY outcome

Timeframe: Day 14

Data are the biomarker serum concentration of C-reactive protein.

Outcome measures

Outcome measures
Measure
White Bread (Control)
n=39 Participants
Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks White Bread (control): Standardized white bread (128 g daily)
Whole Wheat Bread
n=39 Participants
Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks Whole Wheat Bread: Standardized whole wheat bread (128 g daily)
Serum C-reactive Protein
0.53 mg/dL
Standard Error 0.1
0.47 mg/dL
Standard Error 0.1

SECONDARY outcome

Timeframe: Day 14

Data are biomarker serum tumor necrosis factor alpha concentrations.

Outcome measures

Outcome measures
Measure
White Bread (Control)
n=39 Participants
Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks White Bread (control): Standardized white bread (128 g daily)
Whole Wheat Bread
n=39 Participants
Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks Whole Wheat Bread: Standardized whole wheat bread (128 g daily)
Serum Tumor Necrosis Factor Alpha
5.63 pg/mL
Standard Error 0.6
6.39 pg/mL
Standard Error 1.0

SECONDARY outcome

Timeframe: Day 14

Data are biomarker serum interleukin-6 concentrations.

Outcome measures

Outcome measures
Measure
White Bread (Control)
n=39 Participants
Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks White Bread (control): Standardized white bread (128 g daily)
Whole Wheat Bread
n=39 Participants
Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks Whole Wheat Bread: Standardized whole wheat bread (128 g daily)
Serum Interleukin-6
1.94 pg/mL
Standard Error 0.2
1.88 pg/mL
Standard Error 0.2

SECONDARY outcome

Timeframe: Day 14

Data are biomarker fecal concentrations.

Outcome measures

Outcome measures
Measure
White Bread (Control)
n=39 Participants
Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks White Bread (control): Standardized white bread (128 g daily)
Whole Wheat Bread
n=39 Participants
Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks Whole Wheat Bread: Standardized whole wheat bread (128 g daily)
Fecal Calprotectin
35.84 ug/g
Standard Error 5.2
32.8 ug/g
Standard Error 4.6

SECONDARY outcome

Timeframe: Day 14

Data are biomarker fecal concentrations.

Outcome measures

Outcome measures
Measure
White Bread (Control)
n=39 Participants
Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks White Bread (control): Standardized white bread (128 g daily)
Whole Wheat Bread
n=39 Participants
Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks Whole Wheat Bread: Standardized whole wheat bread (128 g daily)
Fecal Myeloperoxidase
157 ng/g
Standard Error 20.9
116 ng/g
Standard Error 31.5

SECONDARY outcome

Timeframe: Day 14

Data are the 24-hour urinary excretion ratio of lactulose relative to mannitol collected 0-5 h following the digestion of non-digestible sugar probes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are the sucralose/erythritol ratio measured in urine collected 6-24 h following the digestion of non-digestible sugar probes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are biomarker fasting concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are biomarker serum concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are expression of toll-like receptor 4 gene from peripheral blood mononuclear cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Expression of myeloid differentiation factor 88 gene from peripheral blood mononuclear cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Expression of tumor necrosis factor alpha gene from peripheral blood mononuclear cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Expression of p65 subunit of nuclear factor kappa B gene from peripheral blood mononuclear cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Expression of interleukin-6 gene from peripheral blood mononuclear cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Expression of interleukin-8 gene from peripheral blood mononuclear cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Expression of myeloperoxidase gene from peripheral blood mononuclear cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Expression of monocyte chemoattractant protein-1 gene from peripheral blood mononuclear cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are biomarker fecal concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are biomarker fecal concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are biomarker fecal concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are biomarker fecal concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are biomarker fecal concentrations of isovaleric acid.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are biomarker serum concentrations of alkylresorcinol and alkylresorcinol derivatives.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are biomarker serum concentrations of benoxazinoids and benoxazinoids derivatives.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are biomarker serum concentrations of phenolic compounds and phenolic derivatives.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are biomarker fecal concentrations of alkylresorcinols and alkylresorcinol derivatives.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are biomarker fecal concentrations of benoxazinoids and benoxazinoids derivatives.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Data are fecal concentrations of phenolic compounds and phenolic derivatives.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0, Day 14

Data are biomarker fasting plasma concentrations.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14

Data are biomarker fasting plasma concentrations.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14

Data are biomarker fasting plasma concentrations.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14

Data are biomarker serum concentrations of alanine transaminase.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14

Data are biomarker serum interleukin-8 concentrations.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14

Alpha-diversity will be determined based on the Shannon-Wiener diversity index. Fecal microbiota assessments and the subsequent determinations of alpha-diversity.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14

Beta-diversity will be determined based on the Bray-Curtis diversity index. Fecal microbiota assessments and the subsequent determinations of beta-diversity.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14

Gut microbiota relative abundance (percent order, genus, and species level) will be measured in fecal samples.

Outcome measures

Outcome data not reported

Adverse Events

Whole Wheat Bread

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

White Bread (Control)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Bruno

The Ohio State University

Phone: 614.292.5522

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place