SalT Reduction InterVEntion: Metabolic, Behavioral and Health Consequences of Reducing Salt in Bread

NCT03810885 | Completed

• 1 other identifier: H-17030995
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is conducted as a randomized controlled trial including children and adults recruited as families. The families are randomly allocated into three groups to investigate the effect of different salt reduction strategies in a period of 3-4 months. Families in the first intervention group are receiving salt reduced bread. Families in the second intervention group are receiving salt reduced bread in combination with dietary counselling to reduce salt and increase potassium intake. Families in the control group are receiving bread with a regular content of salt and no dietary counselling.

Conditions

Salt Intake

Keywords

24hr urine collection

Outcome Measures

Primary Outcomes (1)

• Change from Baseline sodium level in 24 hour urine at 4 months

  Adults average of 3 repeated 24 hour urine, children a single 24hour urine collection; excluding urine first morning including urine of the following morning. Completeness evaluated in adults by Para-Amino-Benzoic-Acid (PABA).

  Measurements at Baseline and at 4 month.

Secondary Outcomes (6)

• Change from Baseline potassium level in 24 hour urine at 4 months

  Measurements at Baseline and at 4 month.

• Change from Baseline Systolic blood pressure at 4 months

  Measurements at Baseline and at 4 month.

• Change from Baseline Diastolic blood pressure at 4 months

  Measurements at Baseline and at 4 month.

• Change from Baseline Adrenaline and Noradrenaline levels in plasma at 4 months

  Measurements at Baseline and at 4 month.

• Change from Baseline Renin and Aldosterone levels in plasma at 4 months

  Measurements at Baseline and at 4 month.

Other Outcomes (10)

• Change from Baseline Glucose levels in plasma at 4 months

  Measurements at Baseline and at 4 month.

• Change from Baseline HbA1C levels in full blood at 4 months

  Measurements at Baseline and at 4 month.

• Change from Baseline Cholesterol levels in plasma (LDL, HDL, total cholesterol and triglycerides) at 4 months

  Measurements at Baseline and at 4 month.

Study Arms (3)

Salt reduced bread

EXPERIMENTAL

Bread with reduced salt content

Other: Bread with reduced salt content

Dietary advice and Salt reduced bread

EXPERIMENTAL

bread with reduced salt content, dietary advice

Other: Bread with reduced salt content; Behavioral: Dietary advice

Normal bread

PLACEBO COMPARATOR

Bread with standard salt content

Other: Bread with standard salt content

Interventions

Bread with reduced salt content OTHER

Bread with gradually lowered salt content

Dietary advice and Salt reduced bread; Salt reduced bread

Dietary advice BEHAVIORAL

Participants will receive information on how to lower salt and increase potassium intake

Dietary advice and Salt reduced bread

Bread with standard salt content OTHER

Bread with normal salt content

Normal bread

Eligibility Criteria

• Age: 3 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants living with children
• Adults 18-69 years
• Children 3-17 years
• Daily intake of bread

You may not qualify if:

• Diabetes
• Cardiovascular disease
• Antihypertensive treatment
• Lipid-lowering treatment
• Pregnancy
• U-albumin \> 300 mg/day
• Celiac disease

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Center fot Clinical Research and Prevention

Glostrup Municipality, Capital Region, 2600, Denmark

Location

MeSH Terms

Interventions

Bread; Nutrition Assessment

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ulla Toft, MSc, PhD

  Capital Region, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be unaware of the treatment groups and the salt content of the bread products will be blinded to the participants. Nurses examining participants at baseline and follow-up will be unaware of which intervention group the families were randomized into. The primary outcome measures will be blinded to the outcome assessors.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD, MSc, Head of Section of Health Promotion and Prevention

Model Details: Active Comparator: Intervention A : Salt reduced bread Assigned Interventions: Participants will receive salt reduced bread and no dietary counselling. Active Comparator: Intervention A+B: Salt reduced bread + Dietary counselling Assigned Interventions: Participants in this group will receive both salt reduced bread and dietary counselling to reduce salt and increase potassium intake. Placebo comparator: Control: normal bread Assigned Interventions: Participants will receive bread with a regular content of salt and no dietary counselling.

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: January 22, 2019
• Study Start: February 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)