Trial Outcomes & Findings for Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals (NCT NCT02602496)

Results Overview

Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for interleukin-6 concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

52 participants

Primary outcome timeframe

8 weeks

Results posted on

2019-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Control 3 servings of refined grains per day. Control: 3 servings of refined grain	Fruits and Vegetables 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables	Whole Grain 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain
Overall Study STARTED	15	20	17
Overall Study COMPLETED	14	18	17
Overall Study NOT COMPLETED	1	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only subjects that finished the study were included in the overall analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=15 Participants 3 servings of refined grains per day. Control: 3 servings of refined grain	Fruits and Vegetables n=20 Participants 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables	Whole Grain n=17 Participants 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=14 Participants • Only subjects that finished the study were included in the overall analysis.	0 Participants n=18 Participants • Only subjects that finished the study were included in the overall analysis.	0 Participants n=17 Participants • Only subjects that finished the study were included in the overall analysis.	0 Participants n=49 Participants • Only subjects that finished the study were included in the overall analysis.
Age, Categorical Between 18 and 65 years	13 Participants n=14 Participants • Only subjects that finished the study were included in the overall analysis.	17 Participants n=18 Participants • Only subjects that finished the study were included in the overall analysis.	17 Participants n=17 Participants • Only subjects that finished the study were included in the overall analysis.	47 Participants n=49 Participants • Only subjects that finished the study were included in the overall analysis.
Age, Categorical >=65 years	1 Participants n=14 Participants • Only subjects that finished the study were included in the overall analysis.	1 Participants n=18 Participants • Only subjects that finished the study were included in the overall analysis.	0 Participants n=17 Participants • Only subjects that finished the study were included in the overall analysis.	2 Participants n=49 Participants • Only subjects that finished the study were included in the overall analysis.
Age, Continuous	27.6 years STANDARD_DEVIATION 5.9 • n=14 Participants • Only subjects that finished the study were included in the analysis	29.4 years STANDARD_DEVIATION 12.8 • n=18 Participants • Only subjects that finished the study were included in the analysis	39.2 years STANDARD_DEVIATION 13.5 • n=17 Participants • Only subjects that finished the study were included in the analysis	32.3 years STANDARD_DEVIATION 12.4 • n=49 Participants • Only subjects that finished the study were included in the analysis
Sex: Female, Male Female	7 Participants n=14 Participants • Only subjects that finished the study were included in the analysis	12 Participants n=18 Participants • Only subjects that finished the study were included in the analysis	11 Participants n=17 Participants • Only subjects that finished the study were included in the analysis	30 Participants n=49 Participants • Only subjects that finished the study were included in the analysis
Sex: Female, Male Male	7 Participants n=14 Participants • Only subjects that finished the study were included in the analysis	6 Participants n=18 Participants • Only subjects that finished the study were included in the analysis	6 Participants n=17 Participants • Only subjects that finished the study were included in the analysis	19 Participants n=49 Participants • Only subjects that finished the study were included in the analysis
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Interleukin-6	3.6 pg/mL STANDARD_DEVIATION 2 • n=14 Participants • Only subjects that finished the study were included in the analysis	3.8 pg/mL STANDARD_DEVIATION 2.2 • n=18 Participants • Only subjects that finished the study were included in the analysis	4.7 pg/mL STANDARD_DEVIATION 3.3 • n=17 Participants • Only subjects that finished the study were included in the analysis	4.05 pg/mL STANDARD_DEVIATION 2.58 • n=49 Participants • Only subjects that finished the study were included in the analysis
high sensitivity C-reactive protein	0.65 mg/mL STANDARD_DEVIATION 0.4 • n=14 Participants • Only subjects that finished the study were included in the analysis	0.69 mg/mL STANDARD_DEVIATION 0.39 • n=18 Participants • Only subjects that finished the study were included in the analysis	0.79 mg/mL STANDARD_DEVIATION 0.56 • n=17 Participants • Only subjects that finished the study were included in the analysis	0.71 mg/mL STANDARD_DEVIATION 0.45 • n=49 Participants • Only subjects that finished the study were included in the analysis
TNF-alpha	23.8 pg/mL STANDARD_DEVIATION 5.9 • n=14 Participants • Only subjects that finished the study were included in the analysis	24.2 pg/mL STANDARD_DEVIATION 5.2 • n=18 Participants • Only subjects that finished the study were included in the analysis	26.7 pg/mL STANDARD_DEVIATION 4.17 • n=17 Participants • Only subjects that finished the study were included in the analysis	24.8 pg/mL STANDARD_DEVIATION 5.2 • n=49 Participants • Only subjects that finished the study were included in the analysis
lipopolysaccharide binding protein	1.83 mg/L STANDARD_DEVIATION 0.27 • n=14 Participants • Only subjects that finished the study were included in the analysis	1.77 mg/L STANDARD_DEVIATION 0.45 • n=18 Participants • Only subjects that finished the study were included in the analysis	1.90 mg/L STANDARD_DEVIATION 0.38 • n=17 Participants • Only subjects that finished the study were included in the analysis	1.83 mg/L STANDARD_DEVIATION 0.38 • n=49 Participants • Only subjects that finished the study were included in the analysis

PRIMARY outcome

Timeframe: 8 weeks

Population: IL-6 was analyzed using an ELISA kit. The mean outcome is the mean of difference between the end and beginning of the treatment period.

Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for interleukin-6 concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.

Outcome measures

Outcome measures
Measure	Control n=14 Participants 3 servings of refined grains per day. Control: 3 servings of refined grain	Fruits and Vegetables n=18 Participants 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables	Whole Grain n=17 Participants 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain
Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0)	0.35 pg/mL Standard Error 0.45	-1.08 pg/mL Standard Error 0.52	0.51 pg/mL Standard Error 0.86

PRIMARY outcome

Timeframe: 8 weeks

Population: TNF-α was analyzed using an ELISA kit. The mean outcome is the mean of difference between the end and beginning of the treatment period.

Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for tumor necrosis factor-α concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.

Outcome measures

Outcome measures
Measure	Control n=14 Participants 3 servings of refined grains per day. Control: 3 servings of refined grain	Fruits and Vegetables n=18 Participants 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables	Whole Grain n=17 Participants 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain
Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0)	-0.36 pg/mL Standard Error 1.58	-1.11 pg/mL Standard Error 1.13	-5.40 pg/mL Standard Error 0.92

PRIMARY outcome

Timeframe: 8 weeks

Population: C-reactive protein was analyzed using an ELISA kit. The mean outcome is the mean of difference between the end and beginning of the treatment period.

Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for high sensitivity C-reactive protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.

Outcome measures

Outcome measures
Measure	Control n=14 Participants 3 servings of refined grains per day. Control: 3 servings of refined grain	Fruits and Vegetables n=18 Participants 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables	Whole Grain n=17 Participants 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain
Change in High Sensitivity C-reactive Protein (Value at Week 8 Minus Value at Week 0)	0.01 mg/mL Standard Error 0.08	-0.06 mg/mL Standard Error 0.06	0.00 mg/mL Standard Error 0.12

PRIMARY outcome

Timeframe: 8 weeks

Population: Lipopolysaccharide binding protein was analyzed using an ELISA kit. The mean outcome is the mean of difference between the end and beginning of the treatment period.

Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for lipopolysaccharide binding protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.

Outcome measures

Outcome measures
Measure	Control n=14 Participants 3 servings of refined grains per day. Control: 3 servings of refined grain	Fruits and Vegetables n=18 Participants 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables	Whole Grain n=17 Participants 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain
Change in Lipopolysaccharide Binding Protein (Value at Week 8 Minus Value at Week 0)	0.14 mcg/mL Standard Error 0.07	-0.21 mcg/mL Standard Error 0.07	-0.21 mcg/mL Standard Error 0.08

SECONDARY outcome

Timeframe: 8 weeks

Population: Alpha diversity was analyzed through the Shannon's Index. The mean outcome is the mean difference between the end and beginning of the treatment period.

The Shannon Diversity Index is a quantitative measure that reflects how many different bacterial species there are in a sample. The greater the index, the more diverse the gut microbiota. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity.

Outcome measures

Outcome measures
Measure	Control n=14 Participants 3 servings of refined grains per day. Control: 3 servings of refined grain	Fruits and Vegetables n=18 Participants 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables	Whole Grain n=17 Participants 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain
Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0)	0.05 Shannon's Index Standard Error 0.15	0.12 Shannon's Index Standard Error 0.09	-0.15 Shannon's Index Standard Error 0.12

SECONDARY outcome

Timeframe: 8 weeks

Population: Mean outcome is the mean difference between the beginning and end of the study. SCFAs were extracted from stool samples and measured using gas chromatography.

Short-chain fatty acids (SCFAs) are the end products of fermentation of dietary fibers by the anaerobic intestinal microbiota. SCFAs have been shown to exert multiple beneficial effects on mammalian energy metabolism.

Outcome measures

Outcome measures
Measure	Control n=14 Participants 3 servings of refined grains per day. Control: 3 servings of refined grain	Fruits and Vegetables n=18 Participants 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables	Whole Grain n=17 Participants 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain
Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)	-45.82 mmol/g Standard Error 22.50	10.72 mmol/g Standard Error 13.50	2.88 mmol/g Standard Error 10.18

SECONDARY outcome

Timeframe: 8 weeks

Population: The outcome mean is the mean difference between the beginning and the end of the study.

Branched chain fatty acids (BCFA) are mostly saturated fatty acids (SFA) with one or more methyl branches on the carbon chain. BCFAs were extracted from stool samples and measured using gas chromatography.

Outcome measures

Outcome measures
Measure	Control n=14 Participants 3 servings of refined grains per day. Control: 3 servings of refined grain	Fruits and Vegetables n=18 Participants 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables	Whole Grain n=17 Participants 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain
Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)	-0.20 mmol/g Standard Error 0.60	-2.41 mmol/g Standard Error 2.79	0.16 mmol/g Standard Error 0.40

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

Population: Weight and height were measured to calculate the BMI. The outcome mean is the mean difference between the beginning and end of the treatment period.

Body mass index will be measured on participants at the beginning (week 0) and end of the study (week 8). Changes in body mass index will be determined.

Outcome measures

Outcome measures
Measure	Control n=14 Participants 3 servings of refined grains per day. Control: 3 servings of refined grain	Fruits and Vegetables n=18 Participants 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables	Whole Grain n=17 Participants 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain
Change in Body Mass Index (Value at Week 8 Minus Value at Week 0)	-0.16 kg/m^2 Standard Error 0.09	-0.22 kg/m^2 Standard Error 0.25	-0.12 kg/m^2 Standard Error 0.10

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fruits and Vegetables

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Whole Grain

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

Dr. Devin Rose

University of Nebraska Lincoln

Phone: 402-472-2802

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place