Trial Outcomes & Findings for Cardiometabolic Benefits of Potatoes Mediated Along the Gut-Vessel Axis in Adults With Metabolic Syndrome (NCT NCT03624569)

NCT ID: NCT03624569

Last Updated: 2025-06-15

Results Overview

Fasting serum endotoxin concentration

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: Day 14
• Results posted on: 2025-06-15

Participant Flow

Participant milestones

Measure	Bagel Diet First and Potato Diet Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment). After a washout period of 2 weeks, they then received an identical diet for 2-weeks that contained potatoes instead of bagels (comparator arm).	Potato Diet First and Bagel Diet Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato. After a washout period of 2 weeks, they then received an identical diet for 2-weeks that contained bagels instead of a potatoes (comparator arm).
First Intervention (2 Weeks) STARTED	20	12
First Intervention (2 Weeks) COMPLETED	19	10
First Intervention (2 Weeks) NOT COMPLETED	1	2
Washout (2 Weeks) STARTED	19	10
Washout (2 Weeks) COMPLETED	19	10
Washout (2 Weeks) NOT COMPLETED	0	0
Second Intervention (2 Weeks) STARTED	19	10
Second Intervention (2 Weeks) COMPLETED	18	9
Second Intervention (2 Weeks) NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Bagel Diet First and Potato Diet Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment). After a washout period of 2 weeks, they then received an identical diet for 2-weeks that contained potatoes instead of bagels (comparator arm).	Potato Diet First and Bagel Diet Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato. After a washout period of 2 weeks, they then received an identical diet for 2-weeks that contained bagels instead of a potatoes (comparator arm).
First Intervention (2 Weeks) Withdrawal by Subject	1	2
Second Intervention (2 Weeks) Protocol Violation	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Baseline Measures - All Participants n=27 Participants Baseline Measures of All Participants Prior To Randomization
Age, Continuous	32.5 years STANDARD_DEVIATION 6.8 • n=27 Participants
Sex: Female, Male Female	14 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=27 Participants
Region of Enrollment United States	27 participants n=27 Participants
Body mass index (kg/m^2)	35 kg/m^2 STANDARD_DEVIATION 5.1 • n=27 Participants
Waist Circumference (cm)	109.8 cm STANDARD_DEVIATION 12.2 • n=27 Participants
Systolic Blood Pressure (mmHg)	120.5 mmHg STANDARD_DEVIATION 8.4 • n=27 Participants
Diastolic Blood Pressure (mmHg)	82.9 mmHg STANDARD_DEVIATION 5.6 • n=27 Participants
Plasma Glucose (mg/dl)	103.7 mg/dL STANDARD_DEVIATION 8.1 • n=27 Participants
Plasma High-density Lipoprotein-Cholesterol (mg/dl)	36.7 mg/dL STANDARD_DEVIATION 7.4 • n=27 Participants
Plasma Triglyceride (mg/dl)	127.6 mg/dL STANDARD_DEVIATION 80.4 • n=27 Participants
Plasma Ascorbic Acid (umol/L)	40.4 umol/L STANDARD_DEVIATION 21.2 • n=27 Participants

PRIMARY outcome

Timeframe: Day 14

Fasting serum endotoxin concentration

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Endotoxin	21.2 EU/mL Standard Deviation 3.0	23.3 EU/mL Standard Deviation 3.0

PRIMARY outcome

Timeframe: Day 14 Postprandial (0, 30, 60, 90, 120 minutes)

Area under curve (change from baseline) for brachial artery flow-mediated dilation (FMD). The unit for FMD is %, which is calculated as: [vessel diameter in millimeters (post-occlusion) - vessel diameter in millimeters (pre-occlusion)] / vessel diameter in millimeters (pre-occlusion) x 100. FMD(%) is then used to caluclate area under the curve based on independent measures of FMD at 0-120 minutes)

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Vascular Endothelial Function	-259 % x min Standard Error 75	-198 % x min Standard Error 71

SECONDARY outcome

Timeframe: Fasting glucose on Day 0

Fasting plasma glucose

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Fasting Glucose Day 0	104 mg/dL Standard Deviation 13.5	109.5 mg/dL Standard Deviation 14.6

SECONDARY outcome

Timeframe: Fasting glucose on Day 14

Fasting plasma glucose Day 14

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Fasting Glucose Day 14	101.9 mg/dL Standard Deviation 12.3	102.3 mg/dL Standard Deviation 13.5

SECONDARY outcome

Timeframe: Fasting insulin on Day 0

Fasting plasma insulin

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Fasting Insulin Day 0	21.1 uIU/mL Standard Error 5.5	17.0 uIU/mL Standard Error 2.0

SECONDARY outcome

Timeframe: Fasting insulin on Day 14

Fasting plasma insulin Day 14

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Fasting Insulin Day 14	14.2 uIU/mL Standard Error 2.0	14.9 uIU/mL Standard Error 2.4

SECONDARY outcome

Timeframe: Day 14 postprandial (0, 30, 60, 90, 120 minutes)

Plasma insulin concentration area under curve change from baseline

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Postprandial Insulin	5940 uIU/mL x min Standard Error 670	7086 uIU/mL x min Standard Error 1372

SECONDARY outcome

Timeframe: Day 14 postprandial (0, 30, 60, 90, 120 minutes)

Postprandial plasma glucose concentration area under curve change from baseline

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Postprandial Glucose	2649 mg/dL x min Standard Error 499	2808 mg/dL x min Standard Error 565

SECONDARY outcome

Timeframe: Day 0

Fasting serum endotoxin concentration

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Fasting Endotoxin	26.6 EU/mL Standard Error 2.0	22.3 EU/mL Standard Error 2.1

SECONDARY outcome

Timeframe: Day 14 postprandial (0, 30, 60, 90, 120 minutes)

Postprandial serum endotoxin concentration area under curve change from baseline

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Postprandial Endotoxin	450 EU/ml x min Standard Error 249	-120 EU/ml x min Standard Error 176

SECONDARY outcome

Timeframe: Day 14, 0-5 hours post-consumption of sugar probes

Urinary concentration of the non-digestible sugars lactulose/mannitol (mg/mg)

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Lactulose/Mannitol Ratio	.154 Ratio (mg/mg) Standard Error .013	.151 Ratio (mg/mg) Standard Error 0.1

SECONDARY outcome

Timeframe: Day 14, 6-24 hours post-consumption of sugar probes

Urinary concentration of the non-digestible sugars sucralose/erythritol

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Sucralose/Erythritol Ratio	.0148 Ratio (mg/mg) Standard Error 0.002	0.01667 Ratio (mg/mg) Standard Error 0.001925

SECONDARY outcome

Timeframe: Day 14

Fecal concentration of butyrate

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Fecal Butyrate	21.3 umol/g Standard Error 2.7	17.9 umol/g Standard Error 2.6

SECONDARY outcome

Timeframe: Day 14

Fecal concentration of acetate

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Fecal Acetate	52.3 umol/g Standard Error 4.7	46.6 umol/g Standard Error 3.9

SECONDARY outcome

Timeframe: Day 14

Fecal concentration of propionate

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Fecal Propionate	23.1 umol/g Standard Error 2.2	19.3 umol/g Standard Error 2.1

SECONDARY outcome

Timeframe: Day 14 postprandial (0, 30, 60, 90, 120 minutes)

Plasma CCK area under curve change from baseline

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Postprandial Cholecystokinin	-196 pmol/L x min Standard Error 266	-67 pmol/L x min Standard Error 344

SECONDARY outcome

Timeframe: Day 14

Fasting plasma concentration of CCK

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Fasting Cholecystokinin	14.3 pmol/L Standard Error 3.1	14.2 pmol/L Standard Error 3.4

SECONDARY outcome

Timeframe: Day 14 postprandial (0, 30, 60, 90, 120 minutes)

Plasma total nitrite/nitrate area under curve change from baseline

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Postprandial NOx	-240 umol/L x min Standard Error 88	-433 umol/L x min Standard Error 48

SECONDARY outcome

Timeframe: Day 14

Fasting plasma concentration of nitrite/nitrate

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Fasting NOx	29.8 umol/L x min Standard Error 3.7	30.1 umol/L x min Standard Error 2.3

SECONDARY outcome

Timeframe: Day 14 postprandial (0, 30, 60, 90, 120 minutes)

Plasma MDA concentration, biomarker of oxidative stress area under curve change from baseline

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Postprandial Malondialdehyde (MDA)	57.2 umol/L x min Standard Error 6.8	45.4 umol/L x min Standard Error 7.2

SECONDARY outcome

Timeframe: Day 14

Fasting plasma MDA concentration, biomarker of oxidative stress

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Fasting Malondialdehyde (MDA)	1.78 umol/L Standard Error .1	1.93 umol/L Standard Error .1

SECONDARY outcome

Timeframe: Day 14

Fasting flow-mediated dilation of the brachial artery. Measure is calculated as: [post-occlusion vessel diameter (mm) - pre-occlusion vessel diameter (mm) / pre-occlusion vessel diameter (mm)] x 100

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Fasting Vascular Endothelial Function	7.2 % change in blood vessel dilation Standard Error 1.3	8.7 % change in blood vessel dilation Standard Error 1.3

SECONDARY outcome

Timeframe: Day 14

Fasting vitamin C concentration, biomarker of oxidative stress

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Vitamin C	47.5 umol/L Standard Error 2.9	52.5 umol/L Standard Error 4.8

SECONDARY outcome

Timeframe: Day 14

Carotid intima-media thickness. Mean thickness of left and right carotid artery intima media.

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
cIMT	0.603 mm Standard Deviation 0.109	0.609 mm Standard Deviation 0.114

SECONDARY outcome

Timeframe: Day 14

Body mass index calculated as kg weight per meters squared

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Day 14 BMI	35.1 kg/m^2 Standard Error 1.1	35.2 kg/m^2 Standard Error 1.1

SECONDARY outcome

Timeframe: Day 0

Waist circumference in centimeters

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Day 0 Waist Circumference	108.5 cm Standard Error 2.2	119.1 cm Standard Error 2.2

SECONDARY outcome

Timeframe: Day 14

Waist circumference in centimeters

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Day 14 Waist Circumference	107.8 mmHg Standard Error 2.4	107.5 mmHg Standard Error 2.4

SECONDARY outcome

Timeframe: Day 0

Diastolic blood pressure on Day 0

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Day 0 Diastolic Blood Pressure	81.5 mmHg Standard Error 1.3	81.9 mmHg Standard Error 1.5

SECONDARY outcome

Timeframe: Day 14

Diastolic blood pressure on Day 14

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Day 14 Diastolic Blood Pressure	75.9 mmHg Standard Error 1.7	77.7 mmHg Standard Error 1.4

SECONDARY outcome

Timeframe: Day 0

Systolic blood pressure on Day 0

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Day 0 Systolic Blood Pressure	123.1 mmHg Standard Error 1.9	119.1 mmHg Standard Error 2.2

SECONDARY outcome

Timeframe: Day 14

Systolic blood pressure on Day 14

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Day 14 Systolic Blood Pressure	113.6 mmHg Standard Error 1.9	114.6 mmHg Standard Error 1.8

SECONDARY outcome

Timeframe: Day 0

Body mass index calculated as kg weight per meters squared

Outcome measures

Measure	Bagel Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment).	Potato Diet n=27 Participants Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato.
Day 0 BMI	35.6 kg/m^2 Standard Error 1.2	35.7 kg/m^2 Standard Error 1.2

Adverse Events

Bagel Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Potato Diet

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, Principal Investigator

The Ohio State University

Phone: 6142925522

Email: bruno.27@osu.edu

Results disclosure agreements

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