Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components

Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components

Change in plasma insulin [ Time Frame: Day 0, Day 14 ]
Plasma concentration (μIU/mL) of insulin will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Change in insulin sensitivity [ Time Frame: Day 14 ]
Evaluated through an oral glucose tolerance test and quantified using the area under the curve (AUC) of the temporal changes in blood glucose and insulin conducted at the end of each intervention arm to assess between-treatment effects.

Small gastrointestinal permeability [ Time Frame: Day 14 ]
Lactulose/mannitol ratio will be measured in urine collected 0-5 h following the digestion of non-digestible sugar probes to assess small intestinal permeability. Excretion ratios will be measured at the end of each intervention arm to assess between-treatment effects.

Colonic gastrointestinal permeability [ Time Frame: Day 14 ]
Sucralose/erythritol ratio will be measured in urine collected 6-24 h following digestion of non-digestible sugar probes to access colonic permeability. Excretion ratios will be measured at the end of each intervention arm to assess between-treatment effects.

Metabolic Endotoxemia [ Time Frame: Day 0, Day 14 ]
Serum endotoxin concentration (EU/mL) will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Serum myeloperoxidase [ Time Frame: Day 0, Day 14 ]
Serum concentration (ng/mL) of myeloperoxidase will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Level of toll-like receptor 4 gene expression [ Time Frame: Day 0, Day 14 ]
Expression of pro-inflammatory toll-like receptor 4 gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Level of myeloid differentiation factor 88 gene expression [ Time Frame: Day 0, Day 14 ]
Expression of pro-inflammatory myeloid differentiation factor 88 gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Level of tumor necrosis factor alpha gene expression [ Time Frame: Day 0, Day 14 ]
Expression of pro-inflammatory tumor necrosis factor alpha gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Level of p65 subunit of nuclear factor kappa B gene expression [ Time Frame: Day 0, Day 14 ]
Expression of pro-inflammatory p65 subunit of nuclear factor kappa B gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Level of interleukin-6 gene expression [ Time Frame: Day 0, Day 14 ]
Expression of pro-inflammatory interleukin-6 gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Level of interleukin-8 gene expression [ Time Frame: Day 0, Day 14 ]
Expression of pro-inflammatory interleukin-8 gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Level of myeloperoxidase gene expression [ Time Frame: Day 0, Day 14 ]
Expression of pro-inflammatory myeloperoxidase gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Level of monocyte chemoattractant protein-1 gene expression [ Time Frame: Day 0, Day 14 ]
Expression of pro-inflammatory monocyte chemoattractant protein-1 gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Fecal calprotectin [ Time Frame: Day 0, Day 14 ]
Fecal concentration (μg/g) of calprotectin will be measured in samples collected and the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Fecal myeloperoxidase [ Time Frame: Day 0, Day 14 ]
Fecal concentration (ng/g) of myeloperoxidase will be measured in samples collected at the beginning and end of each study arm to assess within-treatment and between-treatment effects.

Fecal short-chain fatty acid: butyrate [ Time Frame: Day 0, Day 14 ]
Fecal concentrations (mmol/kg) of butyrate will be measured in samples collected at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Fecal short-chain fatty acid: acetate [ Time Frame: Day 0, Day 14 ]
Fecal concentrations (mmol/kg) of acetate will be measured in samples collected at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Fecal short-chain fatty acid: propionate [ Time Frame: Day 0, Day 14 ]
Fecal concentrations (mmol/kg) of propionate will be measured individually in samples collected at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Fecal short-chain fatty acid: isobutyric acid [ Time Frame: Day 0, Day 14 ]
Fecal concentrations (mmol/kg) of isobutyric acid will be measured in samples collected at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Fecal short-chain fatty acid: isovaleric acid [ Time Frame: Day 0, Day 14 ]
Fecal concentrations (mmol/kg) of isovaleric acid will be measured in samples collected at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Serum whole wheat bread phytochemical: alkylersorcinols [ Time Frame: Day 0, Day 14 ]
Serum concentrations of (nmol/L) alkylresorcinol and alkylresorcinol derivatives will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Serum whole wheat bread phytochemical: benoxazinods [ Time Frame: Day 0, Day 14 ]
Serum concentrations of (nmol/L) benoxazinoids and benoxazinoids derivatives will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Serum whole wheat bread phytochemical: phenolic compounds [ Time Frame: Day 0, Day 14 ]
Serum concentrations of (nmol/L) phenolic compounds and phenolic derivatives will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Intestinal whole wheat phytochemical: alkylresorcinols [ Time Frame: Day 0, Day 14 ]
Fecal concentrations of (μmol/L) alkylresorcinols and alkylresorcinol derivatives will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Intestinal whole wheat phytochemical: benoxazinoids [ Time Frame: Day 0, Day 14 ]
Fecal concentrations of (μmol/L) benoxazinoids and benoxazinoids derivatives will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.

Intestinal whole wheat phytochemical: phenolic compounds [ Time Frame: Day 0, Day 14 ]
Fecal concentrations of (μmol/L) phenolic compounds and phenolic derivatives will be measured at the beginning and end of each intervention arm to assess within-treatment and between treatment effects.

Source: View full study details on ClinicalTrials.gov

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December 20, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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