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Effects of low salt weight loss diets on the way blood vessels work

Effects of weight loss diets low in dietary sodium compared to pre weight loss diet on endothelial function in overweight to obese adults

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001334695
Enrollment
25
Registered
2014-12-18
Start date
2015-04-06
Completion date
2015-05-25
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to see if a combination of weight loss and low salt diets have a beneficial effect on how blood vessels work. We hypothesise that decreasing salt in the diet and losing weight will improve blood vessel function.

Interventions

This is a randomized controlled cross over study. Participants will be randomised into two equal groups matched for body mass index (BMI), sex, age. One group (1) will start with an energy restricted diet using meal replacement low in sodium (meal replacement will be provided for breakfast, lunch and dinner) for 8 weeks followed by a 2 week weight maintenance period on a normal salt diet and finish with a control period of 8 weeks following their normal pre study diet. The second group (2)

This is a randomized controlled cross over study. Participants will be randomised into two equal groups matched for body mass index (BMI), sex, age. One group (1) will start with an energy restricted diet using meal replacement low in sodium (meal replacement will be provided for breakfast, lunch and dinner) for 8 weeks followed by a 2 week weight maintenance period on a normal salt diet and finish with a control period of 8 weeks following their normal pre study diet. The second group (2) will start by following their usual diet for 8 weeks followed by 8 weeks weight loss (as above) finishing with 2 weeks weight maintenance. This study will last for a total of 18 weeks. Participants will be asked to attend maximum 8 appointments at the University of South Australia. The duration of the visits will vary between 15 minutes and 1.5 hours (visits where all measurements are taken will last approximately 1.5 hours (baseline, after 8 weeks weight loss/ control period and after the 2 weeks weight stable period) visits during the weight loss period will last approximately 15 minutes). In the weight loss period participants will attend the University clinic every two weeks to be weighed and to collect meal replacement for the next 2 week period (duration of visit approximately 15 minutes). In the control period participants will be asked to attend the University clinic after 8 weeks (duration approximately 1.5 hours). In this period they will be continuing on their usual diet. To assess food habits a food frequency questionnaire (FFQ) will be completed a t baseline. 3 day diet diaries will be completed at baseline, after 8 weeks weight loss/control period and after the 2 week weight stable period. As a compliance measure weight loss and amount of meal replacement sachets used will be measured. Participants will be asked to return all used and unused meal replacement sachets to be counted.

Sponsors

University of South Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

overweight to obese (BMI greater than or equal to 27 kg/m2) men and women, weight stable within the last 6 months, BP (SBP) <160 mmHg and (DBP) <90 mmHg

Exclusion criteria

BMI less than 27 kg/m2, serious illness e.g. Cancer, liver or kidney disease or not willing or able to follow diet for the study period, alcohol intake above 1 standard drink/day and not willing to decrease intake

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026