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Retention of Potassium From Potatoes and Potassium Gluconate, and the Effect on Blood Pressure.

Primary Purpose

Hypertensive Disease

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Potassium control diet
Potassium gluconate diet
Potato Diet
French Fries Diet
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertensive Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 21 and above
  • Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
  • Pre-hypertensive, (SBP: 120-159mmHg).

Exclusion Criteria:

  • Subjects taking more than one medication to treat hypertension
  • Subject is taking medication to treat hypotension, or medication known to affect electrolyte metabolism or contain high levels of potassium or sodium, smoke cigarettes, use illegal drugs, or excessive alcohol intake.
  • Current use systemic corticosteroids, androgens, phenytoin, erythromycin, thyroid hormones, lipid-lowering medication.
  • Subjects who have hypertension (SBP > 160 mmHg), hypotension (SBP < 120mmHg) or diseases known to affect potassium metabolism (kidney disease or malabsorption disorders). History of myocardial infarction, diabetes mellitus, renal disease, gastrointestinal disease, pancreatitis, cholestatic liver disease, cancer.
  • Subjects who are pregnant.
  • Allergy or intolerance of intervention foods.
  • Unwillingness to refrain from dietary supplements.
  • Weight loss > 3kg in the past 2 months.
  • Subjects with liver and/or lipid abnormalities (elevated alanine amino transferase (ALT) and aspartate amino transferase (AST), dyslipidemia).

Sites / Locations

  • Department of Nutrition Science Purdue University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Arm Label

Control Diet

Potassium Supplement Diet

Potato Diet

French fries Diet

Arm Description

Control (no additional potassium added to diet): Arm will consist of a 16 day balance period with a basal diet set at ~2340mg K/day; based on average American intake.

Potassium gluconate: Arm will consist of a 16 day balance period with the basal (control) diet plus the addition of 1000mg of K/day from potassium gluconate (12 tablets).

Potato diet: Arm will consist of a 16 day balance period with a basal (control) diet with an addition of 1000mg of K/day from white potatoes.

French fry diet: Arm will consist of a 16 day balance period with a basal (control) diet with an addition of 1000mg K/day from French fries.

Outcomes

Primary Outcome Measures

Change in systolic blood pressure
Systolic blood pressure measured directly three consecutive times after 15 min of supine rest.
Potassium balance/retention
Twenty four hour urine and feces will be collected on all intervention days of each phase. Urine will be analyzed for creatinine, K, Na, Ca, Mg according to the urine protocol. Some urine will be stored for future analysis and the rest discarded.
Potassium serum kinetics
Following breakfast, which will include the respective source of potassium or control, pooled urine will be collected at 2, 4, 6, 12 and 24.h. Blood will be drawn (5ml each draw) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6 and 24 hours post breakfast meal. , A catheter will be inserted in the arm at baseline and will be kept there until the blood draw at 6 hours. A needle will be used for the sample at 24 hours. BP will be measured after 4, 6, and 24h.

Secondary Outcome Measures

Change in microcirculation
Vascular flow rate measured via Laser Doppler Flowmetry from right forearm for 60 min from the supine position.
Change in vascular flow rate
Central blood pressure will be measured by pulse wave analysis. Measurements will be repeated at least three times within a 20 minute period after the subject has rested for at least 10 minutes in a seated position. The staff member will place a tonometer (pressure sensor) on the wrist to detect the radial pulse waveform. Measurements will be taken over the course of 5-15 minutes or until pulse wave signal reaches data acquisition parameters.
Acid-base balance
Acid-base balance will be determined on two-end of phase 24 h urine collection to relate to urinary calcium and potassium excretion. Pre-prandial arterialized blood samples will be collected anaerobically using forearm venous blood from the heated hand (10) into a polypropylene syringe containing lyophilized lithium heparin. The blood samples will be stored at room temperature and analyzed within 1 h of collection. Renal acid-base balance will be measured using urinary Net Acid Excretion (NAE) and Potential Renal Acid Load (PRAL).

Full Information

First Posted
February 27, 2016
Last Updated
May 3, 2018
Sponsor
Purdue University
Collaborators
Alliance for Potato Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT02697708
Brief Title
Retention of Potassium From Potatoes and Potassium Gluconate, and the Effect on Blood Pressure.
Official Title
The Effect of Potatoes on Potassium Retention, Acid Base Balance, and Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 27, 2016 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Alliance for Potato Research and Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed to compare the effect of different dietary potassium sources on uptake and retention of potassium, as well as to determine the effect of potassium intake on blood pressure and acid-base balance. The study will compare three different sources of potassium given as a supplement, potatoes or French fries.
Detailed Description
Potassium is a shortfall nutrient according to the 2010 Dietary Guidelines for Americans. Only 3% of Americans meet the recommended Adequate Intake of 4700 mg/d for potassium. Average potassium intake is approximately half of the Recommended Dietary Allowance (RDA), with potatoes providing the highest percentage (19-20% of potassium) in the American diet. Recommended dietary potassium intakes were determined primarily to optimize protection against hypertension and secondarily to protect against stroke and coronary heart disease. In setting requirements for most minerals, bioavailability is usually considered. However, little is known about bioavailability of potassium and what is known is from supplements rather than food. Recently, we performed a potassium bioavailability study on white potatoes looking at 35 healthy, normotensive men and women at 3 levels of potassium intake as potatoes or potassium gluconate supplements. Bioavailability of potassium was determined from AUC of serial blood draws and cumulative urinary excretion. Serum potassium Area Under the Curve (AUC )increased with dose (P<0.0001) and did not differ due to source (p=0.52). Cumulative 24 h urinary potassium also increased with dose (p<0.0001) and was greater with potato than supplement (p<0.0001), concluding that bioavailability of potassium is as high from potatoes as from supplements. These data allow us to evaluate the quality of the food as a source of potassium. However, a remaining question is whether retention of potassium from potatoes is higher than from the salt, which requires a metabolic balance study to determine. The effects of potassium rich foods on blood pressure have also been recently accessed. A controlled feeding study would properly capture potassium retention and balance, as well as adequately control for any positive benefit potassium may have on blood pressure and other vascular outcomes. Increasing potassium citrate decreased titratable acidity and improved calcium retention in a dose response manner in postmenopausal women. There is one Randomized Controlled Trial (RCT) of potassium on bone, in postmenopausal women, showing a benefit of a supplement of potassium chloride on protecting against bone loss. Similar studies have not been performed with food sources of potassium. This study is designed to evaluate the effect of added potassium (K) from potatoes in the diet on K retention , blood pressure, and parameters related to bone health including calcium retention and acid base balance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Participants will receive a controlled diet containing 2340 mg potassium.(K) During the 4 - 16 day phases they will receive an additional 0 mg K, 1000 mg K from potatoes, 1000 mg K from French Fries, and 1000 mg K from supplement in randomized order. Blood pressure will be measured every other day during the intervention. There will be a 2 week washout phase during each phase.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Diet
Arm Type
Placebo Comparator
Arm Description
Control (no additional potassium added to diet): Arm will consist of a 16 day balance period with a basal diet set at ~2340mg K/day; based on average American intake.
Arm Title
Potassium Supplement Diet
Arm Type
Active Comparator
Arm Description
Potassium gluconate: Arm will consist of a 16 day balance period with the basal (control) diet plus the addition of 1000mg of K/day from potassium gluconate (12 tablets).
Arm Title
Potato Diet
Arm Type
Experimental
Arm Description
Potato diet: Arm will consist of a 16 day balance period with a basal (control) diet with an addition of 1000mg of K/day from white potatoes.
Arm Title
French fries Diet
Arm Type
Experimental
Arm Description
French fry diet: Arm will consist of a 16 day balance period with a basal (control) diet with an addition of 1000mg K/day from French fries.
Intervention Type
Dietary Supplement
Intervention Name(s)
Potassium control diet
Other Intervention Name(s)
Control Diet
Intervention Description
No additional potassium.
Intervention Type
Dietary Supplement
Intervention Name(s)
Potassium gluconate diet
Intervention Description
1000 mg K from potassium gluconate.
Intervention Type
Dietary Supplement
Intervention Name(s)
Potato Diet
Intervention Description
1000 mg K from potatoes.
Intervention Type
Dietary Supplement
Intervention Name(s)
French Fries Diet
Intervention Description
1000 mg K from French Fries.
Primary Outcome Measure Information:
Title
Change in systolic blood pressure
Description
Systolic blood pressure measured directly three consecutive times after 15 min of supine rest.
Time Frame
1, 3, 6, 8, 10, 12, 14, 16 days
Title
Potassium balance/retention
Description
Twenty four hour urine and feces will be collected on all intervention days of each phase. Urine will be analyzed for creatinine, K, Na, Ca, Mg according to the urine protocol. Some urine will be stored for future analysis and the rest discarded.
Time Frame
Through out each day of each 16 day intervention
Title
Potassium serum kinetics
Description
Following breakfast, which will include the respective source of potassium or control, pooled urine will be collected at 2, 4, 6, 12 and 24.h. Blood will be drawn (5ml each draw) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6 and 24 hours post breakfast meal. , A catheter will be inserted in the arm at baseline and will be kept there until the blood draw at 6 hours. A needle will be used for the sample at 24 hours. BP will be measured after 4, 6, and 24h.
Time Frame
Day 16 (24 hours) of each intervention period
Secondary Outcome Measure Information:
Title
Change in microcirculation
Description
Vascular flow rate measured via Laser Doppler Flowmetry from right forearm for 60 min from the supine position.
Time Frame
1, and 16 days
Title
Change in vascular flow rate
Description
Central blood pressure will be measured by pulse wave analysis. Measurements will be repeated at least three times within a 20 minute period after the subject has rested for at least 10 minutes in a seated position. The staff member will place a tonometer (pressure sensor) on the wrist to detect the radial pulse waveform. Measurements will be taken over the course of 5-15 minutes or until pulse wave signal reaches data acquisition parameters.
Time Frame
1, 16 days
Title
Acid-base balance
Description
Acid-base balance will be determined on two-end of phase 24 h urine collection to relate to urinary calcium and potassium excretion. Pre-prandial arterialized blood samples will be collected anaerobically using forearm venous blood from the heated hand (10) into a polypropylene syringe containing lyophilized lithium heparin. The blood samples will be stored at room temperature and analyzed within 1 h of collection. Renal acid-base balance will be measured using urinary Net Acid Excretion (NAE) and Potential Renal Acid Load (PRAL).
Time Frame
14, 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 21 and above Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study. Pre-hypertensive, (SBP: 120-159mmHg). Exclusion Criteria: Subjects taking more than one medication to treat hypertension Subject is taking medication to treat hypotension, or medication known to affect electrolyte metabolism or contain high levels of potassium or sodium, smoke cigarettes, use illegal drugs, or excessive alcohol intake. Current use systemic corticosteroids, androgens, phenytoin, erythromycin, thyroid hormones, lipid-lowering medication. Subjects who have hypertension (SBP > 160 mmHg), hypotension (SBP < 120mmHg) or diseases known to affect potassium metabolism (kidney disease or malabsorption disorders). History of myocardial infarction, diabetes mellitus, renal disease, gastrointestinal disease, pancreatitis, cholestatic liver disease, cancer. Subjects who are pregnant. Allergy or intolerance of intervention foods. Unwillingness to refrain from dietary supplements. Weight loss > 3kg in the past 2 months. Subjects with liver and/or lipid abnormalities (elevated alanine amino transferase (ALT) and aspartate amino transferase (AST), dyslipidemia).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Weaver, PhD
Organizational Affiliation
Purdue University, Nutrition Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition Science Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907-2059
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34959951
Citation
Stone MS, Martin BR, Weaver CM. Short-Term Supplemental Dietary Potassium from Potato and Potassium Gluconate: Effect on Calcium Retention and Urinary pH in Pre-Hypertensive-to-Hypertensive Adults. Nutrients. 2021 Dec 9;13(12):4399. doi: 10.3390/nu13124399.
Results Reference
derived
PubMed Identifier
34064968
Citation
Stone MS, Martin BR, Weaver CM. Short-Term RCT of Increased Dietary Potassium from Potato or Potassium Gluconate: Effect on Blood Pressure, Microcirculation, and Potassium and Sodium Retention in Pre-Hypertensive-to-Hypertensive Adults. Nutrients. 2021 May 11;13(5):1610. doi: 10.3390/nu13051610.
Results Reference
derived

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Retention of Potassium From Potatoes and Potassium Gluconate, and the Effect on Blood Pressure.

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