NCT05537857

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 that Blacks retain more calcium and excrete more sodium than white girls on a high sodium diet making Whites more vulnerable to osteoporosis and Blacks more vulnerable to hypertension on high salt diets. Adequate dietary calcium is protective for both groups. This project will compare calcium absorption and calcium and sodium excretion from lactose-free milk as part of a controlled diet on higher (usual Western diet) and lower (recommended) salt intakes in Black, White, Hispanic, and Asian adults.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
7mo left

Started Mar 2023

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

August 17, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

3.4 years

First QC Date

August 17, 2022

Last Update Submit

July 15, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Fractional calcium absorption

    Calcium isotopic tracer

    second day of controlled feeding

  • Urinary calcium

    24-hour

    Entire controlled feeding period

Secondary Outcomes (2)

  • blood and urinary minerals

    Change between baseline and 48 hours

  • blood pressure-both systolic and diastolic

    On Day 3 morning after each 2-day controlled feeding

Study Arms (2)

High dietary salt

EXPERIMENTAL

High salt diet will be tested in random order by all participants.

Other: High dietary salt

Low Dietary salt

EXPERIMENTAL

Low salt diet will be tested in random order by all participants.

Other: High dietary salt

Interventions

High dietary saltOTHER

Controlled feeding study that varies in salt content.

Also known as: Low dietary salt
High dietary saltLow Dietary salt

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults age 18-50 years, but not postmenopausal
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Study Officials

  • Connie Weaver, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Dietary salt will be varied. Kitchen staff will not be blinded. Foods/diet will be coded so blind to investigators interacting with participants and analytical staff although participants may be able to perceive salty foods.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2022

First Posted

September 13, 2022

Study Start

March 1, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Deidentified data will be uploaded to DMPTool

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
When primary manuscript is published and will be available indefinitely.
Access Criteria
Open to public
More information

Locations

US(1)