Trial Outcomes & Findings for Anti-inflammatory Effects of the Fiber (NCT NCT02868788)

Results Overview

mononuclear cells will be isolated by Ficoll-Hypaque method and ROS will be measured by chemiluminescence as an index of NADPH oxidase activation. Measurment will take place at baseline before the meal intervention and hourly for 5 hrs after the meal. The percent change from baseline at peak effect will be calculated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

5hr

Results posted on

2024-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	HFHC Meal Only First Then HFHC Meal Plus Fiber Second Subjects in this arm will receive high fat high calorie (HFHC) meal first Then after 1 week will receive HFHC meal Plus Fiber	HFHC Meal Plus Fiber First Then HFHC Meal Only Second Subjects in this arm will receive high fat high calorie (HFHC) meal Plus Fiber first Then after 1 week will receive HFHC meal only
First Visit STARTED	5	5
First Visit COMPLETED	5	5
First Visit NOT COMPLETED	0	0
Second Visit (One Week Later) STARTED	5	5
Second Visit (One Week Later) COMPLETED	5	5
Second Visit (One Week Later) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Participants n=10 Participants All participants will randomly receive HFHC meal with or without dietary fiber supplementation in first visit and the other intervention in the second visit. Total 10 participants in cross-over design study
Age, Continuous	70 years STANDARD_DEVIATION 5 • n=10 Participants
Sex: Female, Male Female	4 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=10 Participants
Body mass index (BMI)	34 Kg/m^2 STANDARD_DEVIATION 4 • n=10 Participants

PRIMARY outcome

Timeframe: 5hr

mononuclear cells will be isolated by Ficoll-Hypaque method and ROS will be measured by chemiluminescence as an index of NADPH oxidase activation. Measurment will take place at baseline before the meal intervention and hourly for 5 hrs after the meal. The percent change from baseline at peak effect will be calculated.

Outcome measures

Outcome measures
Measure	High Fat High Calorie n=10 Participants Subjects in this arm will receive high fat high calorie meal dietary fiber	High Fat High Calorie Plus Fiber n=10 Participants Subjects in this arm will receive high fat high calorie meal plus dietary fiber supplementation dietary fiber
Peak Change in From Baseline in Reactive Oxygen Species (ROS) Generation	224 percentage of change Standard Error 15	167 percentage of change Standard Error 13

SECONDARY outcome

Timeframe: 5hr

Nuclear factor-Kappa B (NFkB) activation will be measured at baseline before the meal and hourly up to 5 hrs and percent change from baseline at peak effect is calculated

Outcome measures

Outcome measures
Measure	High Fat High Calorie n=10 Participants Subjects in this arm will receive high fat high calorie meal dietary fiber	High Fat High Calorie Plus Fiber n=10 Participants Subjects in this arm will receive high fat high calorie meal plus dietary fiber supplementation dietary fiber
Peak Change in From Baseline in Nuclear Factor-Kappa B (NFkB) Activation	124 percentage of change Standard Error 14	109 percentage of change Standard Error 8

SECONDARY outcome

Timeframe: 5hr

Toll Like Receptor-4 will be measured by Western Blots at baseline before meal intake and hourly up to 5 hrs after meal. Percent change from baseline at peak effect is calculated.

Outcome measures

Outcome measures
Measure	High Fat High Calorie n=10 Participants Subjects in this arm will receive high fat high calorie meal dietary fiber	High Fat High Calorie Plus Fiber n=10 Participants Subjects in this arm will receive high fat high calorie meal plus dietary fiber supplementation dietary fiber
Percent Change Toll Like Receptor-4 (TLR-4) Levels	181 percentage of change Standard Error 15	135 percentage of change Standard Error 12

SECONDARY outcome

Timeframe: 5hr

Lipopolysaccharide will be measured by commercially available kit (Cambrex Limulus Amebocyte Lysate kit, Lonza Inc. Walkersville, MD). Measurements will take place at baseline before the meals and hourly for next 5 hrs. Percent change from baseline at peak effect is calculated.

Outcome measures

Outcome measures
Measure	High Fat High Calorie n=10 Participants Subjects in this arm will receive high fat high calorie meal dietary fiber	High Fat High Calorie Plus Fiber n=10 Participants Subjects in this arm will receive high fat high calorie meal plus dietary fiber supplementation dietary fiber
Change in Plasma Lipopolysaccharides Level From Baseline.	124 percentage of change Standard Error 10	128 percentage of change Standard Error 11

Adverse Events

High Fat High Calorie

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Fat High Calorie Plus Fiber

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

Paresh Dandona

State University of NY at Buffalo

Phone: 7165351852

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place