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

NCT02697708 | Unknown Phase 1 DMC

• 1 other identifier: 1511016780
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertensive Disease

Outcome Measures

Primary Outcomes (3)

• Change in systolic blood pressure

  Systolic blood pressure measured directly three consecutive times after 15 min of supine rest.

  1, 3, 6, 8, 10, 12, 14, 16 days

• 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.

  Through out each day of each 16 day intervention

• 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.

  Day 16 (24 hours) of each intervention period

Secondary Outcomes (3)

• Change in microcirculation

  1, and 16 days

• Change in vascular flow rate

  1, 16 days

• Acid-base balance

  14, 15 days

Study Arms (4)

Control Diet

PLACEBO COMPARATOR

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.

Dietary Supplement: Potassium control diet

Potassium Supplement Diet

ACTIVE COMPARATOR

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).

Dietary Supplement: Potassium gluconate diet

Potato Diet

EXPERIMENTAL

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.

Dietary Supplement: Potato Diet

French fries Diet

EXPERIMENTAL

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.

Dietary Supplement: French Fries Diet

Interventions

Potassium control diet DIETARY_SUPPLEMENT

No additional potassium.

Also known as: Control Diet

Control Diet

Potassium gluconate diet DIETARY_SUPPLEMENT

1000 mg K from potassium gluconate.

Potassium Supplement Diet

Potato Diet DIETARY_SUPPLEMENT

1000 mg K from potatoes.

Potato Diet

French Fries Diet DIETARY_SUPPLEMENT

1000 mg K from French Fries.

French fries Diet

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Purdue University: lead
• Alliance for Potato Research and Education: collaborator

Study Sites (1)

Department of Nutrition Science Purdue University

West Lafayette, Indiana, 47907-2059, United States

Location

Related Publications (2)

• 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.

  PMID: 34959951 DERIVED

• 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.

  PMID: 34064968 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Connie Weaver, PhD

  Purdue University, Nutrition Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2016
• First Posted: March 3, 2016
• Study Start: April 27, 2016
• Primary Completion: August 1, 2018
• Study Completion: December 31, 2018
• Last Updated: May 9, 2018

Record last verified: 2018-05

Locations

US (1)