Sodium Intake Timing 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 Alabama at Birmingham
Must not be taking: Antidepressants, Sleep medications
Disqualifiers: Kidney disease, Elevated BP, Diabetes, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Experimental data have shown that timing of sodium intake impacts diurnal patterns of sodium excretion. The purpose of this study is to test the hypothesis that the time of day for salt intake impacts (1) blood pressure rhythms and urinary sodium excretion and (2) circadian timing of factors responsible for blood pressure regulation and cardiometabolic health in obese individuals. These studies will address two aims. The first aim will test the hypothesis that limiting high salt intake prior to sleep increases day-night differences in blood pressure, improves timing of urinary sodium excretion, and improves metabolic risk factors. The second aim will test the hypothesis that limiting high salt intake prior to sleep preferentially improves rhythmicity in peripheral vs. central circadian clock factors linked to renal sodium handling. The proposed hypothesis-driven studies will determine how timing of sodium intake affects diurnal blood pressure and circadian timing of factors responsible for blood pressure control and metabolic health, with the ultimate goal of identifying novel strategies to treat nocturnal hypertension and metabolic disease in obesity.
Will I have to stop taking my current medications?
If you are taking two or more blood pressure medications or supplements regularly, you may not be eligible for the trial. The protocol does not specify if you need to stop other medications, but it seems focused on limiting certain medications.
What data supports the effectiveness of the treatment Oral sodium supplementation for high blood pressure?
The research suggests that changes in sodium intake can affect blood pressure, but the evidence is mixed and not strong enough to recommend sodium changes as a treatment for high blood pressure. Some studies show that reducing sodium can lower blood pressure, but results vary and are not consistent across different groups.
12345Is oral sodium supplementation generally safe for humans?
There is no specific safety data on oral sodium supplementation, but studies on sodium intake suggest that extreme changes in sodium levels can affect blood pressure. The safety of sodium manipulation in humans varies, and more research is needed to determine its safety and effects.
13567How does oral sodium supplementation differ from other treatments for high blood pressure?
Oral sodium supplementation is unique because it involves adding sodium to the diet, which is contrary to the common approach of reducing sodium intake to manage high blood pressure. This treatment explores the timing and amount of sodium intake, which may have different effects on blood pressure compared to traditional sodium restriction strategies.
34589Eligibility Criteria
This trial is for obese African Americans aged 25-45 with a BMI of 30-50. It's not suitable for those with drug/alcohol abuse history, high alcohol consumption, pregnancy, hormone therapy use, sleep medication or antidepressant users, kidney disease sufferers, very high blood pressure individuals (>150/90 mmHg), shift workers, sleep disorder patients (like apnea), major chronic diseases like diabetes or severe anemia.Inclusion Criteria
My BMI is between 30 and 50.
I am between 25 and 45 years old.
I am between 25 and 45 years old.
+1 more
Exclusion Criteria
You have a serious mental illness, as determined by a specific evaluation form.
My kidney function is reduced or I have abnormal urine test results.
You have smoked or used tobacco products in the last year.
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Run-in Period
Participants consume a standardized diet providing 2.3 g of sodium per day for 7 days
1 week
Treatment
Participants continue the standardized diet for 9 days with additional sodium intake either with dinner or breakfast
9 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if the timing of salt intake affects blood pressure rhythms and urinary sodium excretion in obese people. Participants will limit salt before bedtime to see if it improves day-night blood pressure differences and metabolic risk factors by influencing circadian clock factors linked to renal sodium handling.
2Treatment groups
Experimental Treatment
Group I: Late SodiumExperimental Treatment1 Intervention
Late sodium load: participants will consume a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they will continue to consume the standardized diet for the next 9 days and in addition will take 2 g of sodium with dinner each day.
Group II: Early SodiumExperimental Treatment1 Intervention
Early sodium load: participants will consume a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they will continue to consume the standardized diet for 9 days and in addition will take 2 g of sodium in the form of salt tablets with breakfast each day.
Oral sodium supplementation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Sodium supplements for:
- Sodium deficiency
- Hyponatremia
🇪🇺 Approved in European Union as Oral sodium for:
- Sodium deficiency
- Hyponatremia
- Dehydration
🇨🇦 Approved in Canada as Sodium supplements for:
- Sodium deficiency
- Hyponatremia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of AlabamaBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
References
Effects of moderate sodium restriction on clinic and twenty-four-hour ambulatory blood pressure in elderly hypertensive subjects. [2019]To assess the effects of 80 mmol/day reduction in dietary sodium intake on clinic and 24-h ambulatory blood pressure in elderly hypertensive subjects.
Dietary salt restriction and blood pressure in clinical trials. [2019]Dietary salt has long been recognized as a major factor affecting blood pressure such that sodium intake is a component of lifestyle modification guidelines for control of high blood pressure. These recommendations are based on results from epidemiologic observational studies and clinical trials of various sodium diets among normotensives and hypertensives. Nonetheless, results from the different studies vary such that specific recommendations regarding sodium intake are difficult to interpret. The results from several recent major trials indicated greater associations of blood pressure and sodium intake than earlier studies as well as meta-analyses of numerous clinical trials. The studies of sodium intake and blood pressures are complicated by measurements of intake, salt sensitivity, hypertension treatment, effects of sodium independent of blood pressure, and length of interventions. Limitations in the methodology of different studies have reduced the value of the results to provide specific and reliable sodium intake levels essential for clinical and lifestyle guidelines.
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.
Decreasing dietary sodium while following a self-selected potassium-rich diet reduces blood pressure. [2018]Reducing dietary sodium reduces blood pressure (BP), a major risk factor for cardiovascular disease, but few studies have specifically examined the effect on BP of altering dietary sodium in the context of a high potassium diet. This randomized, crossover study compared BP values in volunteer subjects self-selecting food intake and consuming low levels of sodium (Na+; 50 mmol/d) with those consuming high levels of sodium (> or =120 mmol/d), in the context of a diet rich in potassium (K+). Sodium supplementation (NaSp) produced the difference in Na+ intake. Subjects (n = 108; 64 women, 44 men; 16 on antihypertensive therapy) had a mean age of 47.0 +/- 10.1 y. Subjects were given dietary advice to achieve a low sodium (LS) diet with high potassium intake (50 mmol Na+/d, >80 mmol K+/d) and were allocated to NaSp (120 mmol Na+/d) or placebo treatment for 4 wk before crossover. The LS diet decreased urinary Na+ from baseline, 138.7 +/- 5.3 mmol/d to 57.8 +/- 3.8 mmol/d (P
Dietary sodium and cardiovascular health in hypertensive patients: the case against universal sodium restriction. [2019]Salt and BP have been linked for more than a century. Recent data indicate that, given free access to sodium, in most populations, intake is between 100 and 200 mmol/d, although individual variation is wide. There is good evidence that individual differences are influenced by genetics, environment, and behavior. There is also solid clinical trial data suggesting that substantial reduction in sodium intake (75 to 100 mmol/d) will, on average, lower diastolic pressure by approximately 1 mmHg and systolic by approximately 3 to 5 mmHg. In addition, there is good evidence that sodium restriction is accompanied by other hemodynamic and nonhemodynamic effects. The health effect of sodium restriction can be assessed only by outcome study in humans. The best available evidence in this regard derives from observational study. The several available studies in the general population are inconsistent and demonstrate heterogeneity across subgroups in the relation of sodium intake to cardiovascular morbidity and mortality. Only a single study has been reported in hypertensive patients that links baseline sodium, measured by 24-h urinary excretion, and subsequent cardiovascular outcomes. In that study, controlling for other risk factors, there was a significant, independent, inverse association of urinary sodium excretion and coronary morbidity and mortality. Indeed, an increase of 66 mmol/24 h was associated with a 36% reduction in events. Taken together, these data provide no support for the notion that either normotensive or hypertensive individuals should routinely decrease (or increase) dietary sodium intake.
Reduction of sodium intake is a prerequisite for preventing and curing high blood pressure in hypertensive patients - second part: guidelines. [2019]In the last decade many guidelines and report have been published about the optimal restriction of sodium intake for blood pressure control which deserve to be discussed in the medical community at large. The list includes i. the 2005 Dietary Guidelines of the Department of Health and Human Services and US Department of Agriculture; ii. The 2010 Dietary Guidelines for Americans; iii. The 2011 Presidential Statement of American Heart Association; iiii. The 2012 WHO guidelines on sodium intake in adults and children, v. The 2013 Report of the Institute of Medicine of the National Academies of the United States. All of them support the efficacy and feasibility of sodium restriction for blood pressure control.
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.
The effect of sodium intake on the blood pressure related to age and sex. [2019]Two hundred and one volunteers with no known hypertension and 60 patients with untreated hypertension were entered into a study that compared the effect of two levels of sodium intake on blood pressure. One hundred and fifty-four volunteers and 46 hypertensive patients reached compliance goals, with a urinary sodium excretion on the high sodium diet twice that on the reduced sodium intake. The blood pressure on the high sodium diet was 4.5 +/- 0.5 mmHg (n = 154 p less than 0.001) higher than on the reduced sodium diet in normotensive individuals and was increased by 8.4 +/- 1.5 mmHg (n = 46 p less than 0.001) in hypertensive individuals. In the volunteer group the major rise in blood pressure occurred in people over the age of 50. In the hypertensive patients the alteration in blood pressure was not age dependent. In the younger age groups some individuals had an increase in blood pressure when on the high sodium intake which was outside the spontaneous variations in blood pressure of a control group. This implied that a number of young normotensive individuals were susceptible to this alteration in sodium intake. Changes in sodium intake alter blood pressure in hypertensive people, in normotensive people over 50 and in a small number of younger normotensive people. Overall reduction of sodium intake from 200 - 70 mmol/day would reduce the blood pressure level of the population and would reduce the number of people who have a blood pressure that requires drug therapy.
Blood pressure response to sodium restriction and potassium supplementation in healthy normotensive children. [2019]To examine the effects of dietary sodium on blood pressure 149 healthy, normotensive children (64 males, 85 females) participated in a study to restrict sodium intake to 60 mEq/day or half of the usual intake for 3 months. Sodium excretion was significantly decreased during the study period (100.6 +/- 3.4 mEq vs 46.5 +/- 2.0 mEq, P less than .001). As a group there was no significant change in systolic and a small decrease in diastolic blood pressure (54.2 +/- 0.8 mmHg vs 53.0 +/- 0.7 mmHg, p less than .03, one tailed). Adjustment of blood pressure for weight and age and analysis of residuals yielded significant decreases in both mean arterial (p less than .05) and diastolic blood pressure (p less than .05). In the potassium supplement study, comparison of supplementation to post-supplement periods in 31 children (13 male, 18 female) showed a significantly lower (p less than .05) systolic blood pressure during supplementation (101.3 +/- 2.1 mmHg vs 103.3 +/- 20 mmHg). Analyses of diastolic pressures, sodium excretion and weight were not significant. These studies show heterogeneity in the blood pressure response to sodium restriction and suggest that sodium restriction and potassium supplementation have different effects on blood pressure in children.