Sodium Intake Modification for High Blood Pressure
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Delaware
No Placebo Group
Trial Summary
What is the purpose of this trial?The ability of the brain to sense changing sodium levels in the blood is critical in mediating the neurohumoral responses to hypernatremia, however, the mechanisms underlying sodium sensing in humans is poorly understood. The purpose of this study is to identify key sodium-sensing regions of the human brain in older adults and determine if the Na-K-2Cl co-transporter mediates the neurohumoral response to acute hypernatremia. Completion of this project will increase our understanding of blood pressure regulation, which has major public health implications.
Do I have to stop taking my current medications for the trial?
Yes, you must stop taking psychiatric, neurological, anxiety, depression, and hypertension medications to participate in the trial.
What data supports the idea that Sodium Intake Modification for High Blood Pressure is an effective treatment?
The available research shows that sodium intake modification can be effective in managing high blood pressure, especially when patients are actively involved in the process. For example, a study found that group management, where patients support each other and receive feedback on their sodium levels, was more effective in reducing sodium intake than just receiving advice or education. Another study suggests that reducing sodium can be a simple and safe way to help manage high blood pressure, especially for those with mild cases. However, the effectiveness can be limited by how well patients stick to the diet, as seen in a study where low salt advice only slightly lowered blood pressure in patients who were already on medication. Overall, involving family and using motivational techniques can improve the success of sodium reduction as a treatment.
12345What safety data exists for sodium intake modification in treating high blood pressure?
The safety data for sodium intake modification in treating high blood pressure is mixed. Some studies suggest that sodium restriction is a simple, safe, and effective therapy for hypertension, particularly as an adjunct to thiazide diuretics. However, other studies highlight challenges, such as the low adherence to sodium-restricted diets without intensive programs and the ineffectiveness of single-session dietary counseling. The SOTRUE trial showed feasibility but not significant efficacy or safety in a short-term study of older adults. Overall, while sodium reduction can lower blood pressure, more extensive studies are needed to confirm its safety and efficacy.
14678Is reducing sodium intake a promising treatment for high blood pressure?
Yes, reducing sodium intake is a promising treatment for high blood pressure. It is a simple and safe way to help lower blood pressure, especially for people with mild hypertension. Studies show that eating less sodium can lead to a significant decrease in blood pressure, which can improve heart health and potentially save many lives.
24679Eligibility Criteria
This trial is for adults aged 18-45 with normal blood pressure and potassium levels, who have a BMI within the range of 18.5 to 30 kg/m2. It's designed for those without any known allergies or salt sensitivity issues that affect their blood pressure.Inclusion Criteria
I am between 18 and 45 years old.
BMI: 18.5 kg/m2 - 30 kg/m2
Blood pressure: >100/60 mmHg and <130/80 mmHg
+1 more
Exclusion Criteria
I am taking medication for a psychiatric condition.
Abnormal ECG
Serum potassium: < 3.5 mmol/L or > 5.5 mmol/L
+21 more
Participant Groups
The study aims to understand how the brain detects changes in blood sodium levels and its role in controlling blood pressure. Participants will undergo dietary interventions and receive hypertonic saline to identify key brain regions involved in sodium sensing.
2Treatment groups
Experimental Treatment
Group I: Salt Sensitivity AssessmentExperimental Treatment1 Intervention
1 week high salt diet and 1 week low salt diet
Group II: Functional Magnetic Resonance ImagingExperimental Treatment1 Intervention
Hypertonic saline infusion perturbation with and without NKCC2 antagonism (furosemide) to examine sodium sensing mechanisms
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
William B FarquharNewark, DE
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Who Is Running the Clinical Trial?
University of DelawareLead Sponsor
References
Failure of single-session dietary counseling to reduce salt intake in hypertensive patients. [2019]Twelve ambulatory, stable, hypertensive patients were studied to determine the effect of a single, structured session of dietary counseling on daily sodium intake. The patients understood the material presented to them, as measured by testing six weeks after the original session, and they perceived themselves as having substantially reduced their daily salt intake (p less than 0.005); objective assessment of dietry sodium from measurement of 24-hour urinary sodium excretion, however, showed no significant decrease in this patient group. We conclude that single-session dietary counseling in hypertensive patients is unlikely to result in significant reductions in daily salt intake.
What should we tell patients with heart failure about sodium restriction and how should we counsel them? [2022]This article is a review of current evidence regarding the recommended level of dietary sodium, involvement of family members in adoption of a low sodium diet, and evidence-based strategies to increase patient and family member willingness and ability to a follow a low sodium diet. The available evidence suggests that recommending a 2.5 to 3 g sodium diet will meet nutritional needs and decrease risk of hospitalizations. The best strategy identified for patient success is to fully involve both patients and family members in jointly reducing sodium intake. Motivational interviewing techniques should be used before counseling begins to guide patients and family members toward realization of the need to follow a low sodium diet. Successful counseling starts with determining perceptions, barriers, and individual characteristics that impede adherence. This information is incorporated into theory-based teaching strategies to promote behavior change and successful adoption of a low sodium diet.
Salt restriction in hypertensive patients. Comparison of advice, education, and group management. [2013]The purpose of this study was to identify the best of three methods of treating hypertensive outpatients in order to minimize dietary sodium levels and thereby decrease the need for antihypertensive drugs. Forty-eight outpatients with hypertension were randomly assigned to three treatment programs: (1) advice; (2) an intensive educational program; and (3) small-group management plus feedback. This last program had a problem-solving format in which patients shared ideas and provided mutual support for dietary change. Only these group management patients were told the results of their sodium determinations. In a one-year study, group management plus the feedback to patients of information on the sodium content of their urine was more effective in decreasing dietary sodium intake than advice or an intensive educational effort.
Sodium restriction in the treatment of hypertension. [2004]There is a need for nonpharmacologic approaches to hypertension treatment, particularly in those patients with mild elevations in blood pressure. Evidence suggests that development of hypertension is related to excess sodium ingestion in many people and that sodium restriction provides simple, safe, and effective therapy. Dietary sodium restriction should be considered as initial and adjunctive therapy for hypertensive persons, particularly those who are receiving thiazide diuretics. Although validated methods of estimating dietary sodium intake are not yet established, overnight urinary collections provide a convenient approach. Chemical chloride strips may greatly facilitate compliance.
Is low salt dietary advice a useful therapy in hypertensive patients with poorly controlled blood pressure? [2016]In order to decide whether or not to advise a low Na trial routinely in a hypertension clinic, a randomised controlled 'management' trial was conducted to assess dietary compliance, well-being and changes in antihypertensive medication as a result of such a diet. Sixty-five out-patients on drug treatment for hypertension but with diastolic blood pressures greater than 95 mm Hg on two successive occasions were randomly allocated either to an index group on a 1 g Na (44 mmol) daily diet or to a reference group. Dietary advice was given in detail and repeated as necessary to ensure there was no misunderstanding. After three months 28% of the index group still added salt to their cooking and 13% sometimes added salt at the table. The difference between the groups in 24-hour Na excretion averaged 59 mmol at the end of the trial but 55% of the index group had a 24-hour Na excretion greater than 80 mmol. The average blood pressure at the end of the trial was only a 4 mm Hg systolic and 3 mm Hg diastolic lower in the index group. However, this modest benefit was achieved without any obvious deterioration in the quality of the lives of the patients on the low Na diet. The index group enjoyed their food as much as before and tended to require less drug treatment. On the debit side the index group complained more of transient unsteadiness (p less than 0.05) suggestive of postural hypotension. Low salt dietary advice is only marginally effective in patients poorly controlled on drug treatment. Non-compliance limits the usefulness of the advice.
Sodium manipulation in the management of hypertension. The view against its general use. [2019]Extreme changes in sodium intake do have an effect on blood pressure of both normotensive and hypertensive individuals. Cross-population correlates of average sodium intake and mean population blood pressure are discordant with the results of studies within single populations and cannot be used as sufficient evidence to justify a reduction of dietary sodium intake in the general population to prevent hypertension. Both explanatory and management trials of sodium restriction have yielded contradictory results, and convincing evidence on the nature and size of subgroups of hypertensives with enhanced sodium sensitivity is lacking. The proportion of patients who will follow a moderately restricted sodium diet is low, unless expensive and time-consuming programs of instruction and monitoring are introduced. In light of this evidence, it is premature to recommend diets that are low in sodium as a public health measure and as initial and sole treatment of hypertension.
Reducing the population burden of cardiovascular disease by reducing sodium intake: a report of the Council on Science and Public Health. [2008]Across populations, the level of blood pressure, the incremental rise in blood pressure with age, and the prevalence of hypertension are directly related to sodium intake. Observational studies and randomized controlled trials document a consistent effect of sodium consumption on blood pressure. The majority of sodium consumption in the United States is derived from amounts added during food processing and preparation. Leading scientific organizations and governmental agencies advise limiting sodium intake to 2400 mg or less daily (approximately 6000 mg of salt). Substantial public health benefits accrue from small reductions in the population blood pressure distribution. A 1.3-g/d lower lifetime sodium intake translates into an approximately 5-mm Hg smaller rise in systolic blood pressure as individuals advance from 25 to 55 years of age, a reduction estimated to save 150,000 lives annually. With an appropriate food industry response, combined with consumer education and knowledgeable use of food labels, the average consumer should be able to choose a lower-sodium diet without inconvenience or loss of food enjoyment. In the continued absence of voluntary measures adopted by the food industry, new regulations will be required to achieve lower sodium concentrations in processed and prepared foods.
The Effects of a Low Sodium Meal Plan on Blood Pressure in Older Adults: The SOTRUE Randomized Feasibility Trial. [2021]Reduced sodium meal plans are recommended by the Centers of Disease Control to lower blood pressure in older adults; however, this strategy has not been tested in a clinical trial. The Satter House Trial of Reduced Sodium Meals (SOTRUE) was an individual-level, double-blind, randomized controlled pilot study of adults living in a congregate living facility subsidized by the Federal Department of Housing and Urban Development (HUD). Adults over age 60 years ate 3 isocaloric meals with two snacks daily for 14 days. The meal plans differed in sodium density (<0.95 vs. >2 mg/kcal), but were equivalent in potassium and macronutrients. Seated systolic BP (SBP) was the primary outcome, while urine sodium-creatinine ratio was used to measure compliance. Twenty participants were randomized (95% women; 95% white; mean age 78 ± 8 years), beginning in 7 October 2019. Retention was 100% with the last participant ending 4 November 2019. Mean baseline SBP changed from 121 to 116 mmHg with the typical sodium diet (-5 mmHg; 95% CI: -18, 8) and from 123 to 112 mmHg with the low sodium diet (-11 mmHg; 95% CI: -15.2, -7.7). Compared to the typical sodium meal plan, the low sodium meal plan lowered SBP by 4.8 mmHg (95% CI: -14.4, 4.9; p = 0.31) and urine sodium-creatinine ratio by 36% (-36.0; 95% CI: -60.3, 3.4; p = 0.07), both non-significant. SOTRUE demonstrates the feasibility of sodium reduction in federally mandated meal plans. A longer and larger study is needed to establish the efficacy and safety of low sodium meals in older adults.
A factorial study of fat and fibre changes and sodium restriction on blood pressure of human hypertensive subjects. [2019]1. Diets used to reduce sodium intake often involve changes in fats and fibre which might themselves affect blood pressure and/or lipid metabolism. To evaluate the relative importance of these dietary changes for the management of hypertension we have studied the independent and additive effects of sodium restriction (less than 60 mmol/day) and a low fat (30% energy), high P/S ratio (1.0), high fibre (30-50 g/day) 'cholesterol lowering' diet. 2. Ninety-five hypertensives entered a four group parallel study with a factorial design. Following 5 weeks familiarization subjects [BP range 109/66-168/105 mmHg] were randomly assigned to either a 'low sodium, cholesterol lowering' diet or a 'low sodium, cholesterol maintaining' diet. Half the subjects in each group were then assigned to 100 mmol/day NaCl supplement and the remainder to placebo. These diets were continued for 8 weeks. Seventy-nine of the 91 hypertensives who completed the study were on antihypertensive therapy throughout. 3. Mean urinary sodium excretion decreased from 137 (54 mmol/day (n = 43) at baseline (B) to 52 (32) mmol/day (n = 45, P = 0.0001) during intervention (I) in the low sodium groups and remained unchanged in the groups which received slow sodium (B = 129 [46], n = 43; I = 134 [29], n = 42). Diet record and plasma fatty acid analysis confirmed that the dietary aims of the study were achieved. 4. Sodium restriction reduced supine and standing systolic BP by a mean (+/- s.e.m.) of 6 +/- 2 and 6 +/- 4 mmHg, respectively (P less than 0.005).(ABSTRACT TRUNCATED AT 250 WORDS)