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临床试验/NCT02697708
NCT02697708Unknown1 期

The Effect of Potatoes on Potassium Retention, Acid Base Balance, and Blood Pressure

Purdue University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年4月27日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
40
试验地点
2
主要终点
Potassium serum kinetics

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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).

研究组 & 干预措施

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.

干预措施: Potassium control diet (Dietary Supplement)

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).

干预措施: Potassium gluconate diet (Dietary Supplement)

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.

干预措施: Potato Diet (Dietary Supplement)

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.

干预措施: French Fries Diet (Dietary Supplement)

结局指标

主要结局

Potassium serum kinetics

时间窗: Day 16 (24 hours) of each intervention period

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.

Potassium balance/retention

时间窗: Through out each day of each 16 day intervention

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.

Change in systolic blood pressure

时间窗: 1, 3, 6, 8, 10, 12, 14, 16 days

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

次要结局

  • Change in vascular flow rate(1, 16 days)
  • Change in microcirculation(1, and 16 days)
  • Acid-base balance(14, 15 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Berdine Martin

Research Scientist

Purdue University

研究点 (2)

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