Trial Outcomes & Findings for Potato Research for Enhancing Metabolic Outcomes (NCT NCT04203238)
NCT ID: NCT04203238
Last Updated: 2023-11-07
Results Overview
Change in area under the curve for blood glucose (mg/dL/min) concentration in response to the diet. Negative values are considered a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
Potatoes Lean Meat (PLM)
The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.
|
Lean Meat Pulses (LMP)
The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day.
Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Potatoes Lean Meat (PLM)
The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.
|
Lean Meat Pulses (LMP)
The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day.
Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Covid-19
|
3
|
0
|
Baseline Characteristics
Potato Research for Enhancing Metabolic Outcomes
Baseline characteristics by cohort
| Measure |
Potatoes Lean Meat (PLM)
n=18 Participants
The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.
|
Lean Meat Pulses (LMP)
n=18 Participants
The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day.
Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 Years and standard error
STANDARD_DEVIATION 2.6 • n=5 Participants
|
45.4 Years and standard error
STANDARD_DEVIATION 2.6 • n=7 Participants
|
45 Years and standard error
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksChange in area under the curve for blood glucose (mg/dL/min) concentration in response to the diet. Negative values are considered a better outcome.
Outcome measures
| Measure |
Potatoes Lean Meat (PLM)
n=18 Participants
The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.
|
Lean Meat Pulses (LMP)
n=18 Participants
The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
|
|---|---|---|
|
Glycemic Response to the Diet
|
-103.44 mg/dL/min
Standard Error 430.04
|
-501.91 mg/dL/min
Standard Error 406.83
|
SECONDARY outcome
Timeframe: Baseline and 8 weekschange in area under the curve for blood insulin (uU/mL/min) concentration in response to the diet. Negative values are considered a better outcome.
Outcome measures
| Measure |
Potatoes Lean Meat (PLM)
n=18 Participants
The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.
|
Lean Meat Pulses (LMP)
n=18 Participants
The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
|
|---|---|---|
|
Insulin Response to the Diet
|
-966.63 uU/ml/min
Standard Error 1012.49
|
-2136.32 uU/ml/min
Standard Error 955.53
|
SECONDARY outcome
Timeframe: Baseline and 8 weekschange in blood cholesterol (mg/dL) concentration in response to the diet. Negative values are considered a better outcome.
Outcome measures
| Measure |
Potatoes Lean Meat (PLM)
n=18 Participants
The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.
|
Lean Meat Pulses (LMP)
n=18 Participants
The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
|
|---|---|---|
|
Cholesterol Response to the Diet
|
-5.01 mg/dL
Standard Error 3.57
|
-11.79 mg/dL
Standard Error 3.25
|
SECONDARY outcome
Timeframe: Baseline and 8 weekschange in blood triglyceride (mg/dL) concentration in response to the diet. Negative values are considered a better outcome.
Outcome measures
| Measure |
Potatoes Lean Meat (PLM)
n=18 Participants
The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.
|
Lean Meat Pulses (LMP)
n=18 Participants
The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
|
|---|---|---|
|
Triglyceride Response to the Diet
|
-4.67 mg/dL
Standard Error 19.25
|
-2.88 mg/dL
Standard Error 17.94
|
SECONDARY outcome
Timeframe: Baseline and 8 weekschange in LDL particle size (nm) in response to the diet. Negative values are considered a better outcome.
Outcome measures
| Measure |
Potatoes Lean Meat (PLM)
n=18 Participants
The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.
|
Lean Meat Pulses (LMP)
n=18 Participants
The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
|
|---|---|---|
|
LDL Particle Size Response to the Diet
|
-0.27 nm
Standard Error 0.13
|
-0.38 nm
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline and 8 weekschange in hsCRP (mg/L) in response to the diet. Positive values are considered a worse outcome.
Outcome measures
| Measure |
Potatoes Lean Meat (PLM)
n=18 Participants
The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.
|
Lean Meat Pulses (LMP)
n=18 Participants
The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.
Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
|
|---|---|---|
|
hsCRP Response to the Diet
|
0.51 mg/L
Standard Error 1.43
|
0.24 mg/L
Standard Error 1.32
|
Adverse Events
Potatoes Lean Meat (PLM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lean Meat Pulses (LMP)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Potatoes Lean Meat (PLM)
n=18 participants at risk
The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day.
Reduced Meat High Potato Diet: The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.
|
Lean Meat Pulses (LMP)
n=18 participants at risk
The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day.
Reduced Meat High Pulses Diet: The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
|
|---|---|---|
|
Gastrointestinal disorders
gastrointestinal
|
0.00%
0/18 • 8 weeks
|
11.1%
2/18 • Number of events 2 • 8 weeks
|
Additional Information
Dr. Candida Rebello
Pennington Biomedical Research Center
Phone: 2257633159
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place