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Clinical Trial NCT05537857 for Healthy is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Racial/Ethnic in Calcium and Sodium Metabolism 66 Adolescent Dietary Personalized Treatment

Active, not recruiting
Clinical Trial NCT05537857 is an interventional study for Healthy that is active, not recruiting. It started on 1 March 2023 with plans to enroll 66 participants. Led by San Diego State University, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 18 July 2025.
Brief Summary
The increased interest in personalized nutrition has arisen because scientists are beginning to understand subgroup differences in response to the environment including diet. Some suggest that dietary guidance which promotes milk is racially and ethnically insensitive because of higher prevalence of lactose intolerance/maldigestion in non-white groups. Preliminary evidence in Black and White adolescent girls shows th...Show More
Detailed Description
Experimental design: Seventy-six adults aged 18-50 years (19 white, 19 Black, 19 Hispanic, and 19 Asians) will be recruited to complete 16 in each group and tested on two levels of dietary salt (lower = 2300 mg/Na/d and higher = 3700 mg Na/d) in randomized order. The primary outcome measures are fractional calcium absorption and urinary calcium excretion. Secondary outcome measures are urinary sodium excretion and wh...Show More
Official Title

Racial/Ethnic Differences in Calcium Metabolism in Response to Dietary Sodium

Conditions
Healthy
Other Study IDs
  • HS-2022-0135
NCT ID Number
NCT05537857
Start Date (Actual)
2023-03-01
Last Update Posted
2025-07-18
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
66
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalHigh dietary salt
High salt diet will be tested in random order by all participants.
High dietary salt
Controlled feeding study that varies in salt content.
ExperimentalLow Dietary salt
Low salt diet will be tested in random order by all participants.
High dietary salt
Controlled feeding study that varies in salt content.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Fractional calcium absorption
Calcium isotopic tracer
second day of controlled feeding
Urinary calcium
24-hour
Entire controlled feeding period
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
blood and urinary minerals
total calcium, magnesium, sodium and ionized calcium and magnesium
Change between baseline and 48 hours
blood pressure-both systolic and diastolic
Average of 3 seated readings from automated sphygmomanometer
On Day 3 morning after each 2-day controlled feeding
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Healthy adults age 18-50 years, but not postmenopausal
  • 3 of 4 grandparents identified as one of four major racial/ethnic groups
  • BMI between 18.5 and 30 AND waist circumference less than or equal to 88 cm for females and 102 cm for males
  • No allergy to lactose-free milk.

  • Taking vasoactive or calcium metabolism-altering medications (statins, antihypertensives, aspirin, steroids, bisphosphonates, thiazide diuretics, hormone replacement therapy, and antidepressants)
  • Had bone fracture within the past 6 months
  • Diabetes
  • Cance
  • Liver disease
  • Gastrointestinal disease (e.g.: Crohn's disease, irritable bowel syndrome, malabsorption syndrome)
  • Decreased kidney function
  • Smoking within the past 12 months before the study.
  • Habitually consumption > 1000 mg Ca/d from food or supplements.
San Diego State University logoSan Diego State University
No contact data.
1 Study Locations in 1 Countries

California

San Diego State University, San Diego, California, 92182, United States