High Potassium Diet with Spices and Herbs As Salt Substitute for Lowering Blood Pressure in Older Adults: Study Protocol

NCT06683430 | Completed

• 1 other identifier: 35/EC/KEPK/FKUA/2023
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the High Potassium Diet Rich in Spices and Herbs-Salt Substitution (HPSH-SS) for reducing blood pressure in older adults. The study has two phases: the first focuses on developing a high-potassium, low-sodium diet, while the second involves a 14-day randomized controlled trial. Participants are divided into two groups: the intervention group (IG) receives an 1800 kcal daily diet with 3500 mg potassium and 1500 mg sodium, while the control group (CG) receives a diet with 1500 mg potassium and 2000 mg sodium. Key outcomes include changes in blood pressure, serum potassium, aldosterone, nitric oxide, and oxidative stress markers. The results could provide new dietary strategies for managing blood pressure in the elderly.

Conditions

Hypertension; Older Adults Institutionalized in Residential Homes

Keywords

sodium; potassium; spices and herbs; blood pressure; hypertension; elderly; protocol study; gerontology; dietary; anti-hypertensive; oxidative stress

Outcome Measures

Primary Outcomes (1)

• Change in Blood Pressure (mmHg)

  Measurement of the change in systolic and diastolic blood pressure from baseline to Day 8 and Day 15 to evaluate the effect of the high-potassium, low-sodium diet intervention.

  Baseline, Day 8, and Day 15

Secondary Outcomes (7)

• Change in Urinary Potassium Levels (mmol)

  Baseline, Day 15

• Change in Urinary Sodium Levels (mmol)

  Baseline, Day 15

• Change in Serum Potassium Levels (mmol/L)

  Baseline, Day 15

• Change in Plasma Nitric Oxide Levels (µmol/L)

  Baseline, Day 15

• Change in Plasma F2-Isoprostane Levels (pmol/L)

  Baseline, Day 15

Study Arms (2)

Intervention Group High Potassium, Low Sodium Diet

ACTIVE COMPARATOR

Participants received a diet enriched with potassium (3500 mg K) and reduced sodium (1500 mg Na) for 14 days.

Dietary Supplement: High Potassium, Low Sodium Diet

Control Group Standard Diet (Low Potassium)

PLACEBO COMPARATOR

Participants received a standard diet with low potassium (1700 mg K) and high sodium (2000 mg Na) daily for 14 days.

Dietary Supplement: Standard Diet

Interventions

High Potassium, Low Sodium Diet DIETARY_SUPPLEMENT

Daily intake of 3500 mg K and 1500 mg Na for 14 days.

Intervention Group High Potassium, Low Sodium Diet

Standard Diet DIETARY_SUPPLEMENT

Daily intake of 1700 mg K and 2000 mg Na for 14 days.

Control Group Standard Diet (Low Potassium)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older adults aged ≥60 years residing in the nursing
• active and not bedridden
• without infectious disease, taste disorders, or dementia
• have blood pressure measurements indicating a systolic blood pressure (SBP) ≥130 mmHg and/or diastolic blood pressure (DBP) ≥85 mmHg

You may not qualify if:

• individuals with impaired kidney function (creatinine serum levels \>1.2 mmol/L)
• uncontrolled diabetes mellitus (fasting blood sugar \>126 mg/dL)
• obesity (BMI ≥30 kg/m2 )
• active smokers
• have memory impairment and depressive conditions
• participants declining continued participation, requiring intensive hospital care, or experiencing persistent vomiting and diarrhea were excluded from the intervention.

Sponsors & Collaborators

• Universitas Airlangga: lead

Study Sites (1)

government institutional setting in Surabaya, Indonesia, namely Griya Wreda Surabaya nursing home.

Surabaya, Jawa Timur, 60232, Angola

Location

MeSH Terms

Conditions

Hypertension

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 12, 2024
• Study Start: May 11, 2022
• Primary Completion: June 30, 2023
• Study Completion: February 9, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AN (1)