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The influence of proline betaine in orange juice on homocysteine concentrations in healthy male Caucasians

A study to compare orange juice versus supplementation with proline betaine on homocysteine concentrations in healthy male Caucasians

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000501549
Enrollment
8
Registered
2006-12-05
Start date
2006-11-27
Completion date
Unknown
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

People with high blood levels of homocysteine have an increased risk of heart disease and stroke. A previous study by our group has shown that a molecule called 'proline betaine' increased plasma homocysteine levels in rats. Proline betaine is found in the diet with particularly high levels citrus fruits and alfalfa sprouts. This research will investigate whether drinking orange juice raises homocysteine levels healthy male volunteers and if this is a result of proline betaine content. We hope to learn more about how proline betaine influences homocysteine metabolism and whether it has a role in vascular disease.

Interventions

Subjects will receive a single dose of two treatments (a, b) in random order. Treatment (a) is 750 mL orange juice, treatment (b) is proline betaine (0.532g dissolved in 750 mL apple juice). The treatment duration will be one day (24 hours) each week for three consecutive weeks with a wash-out period of 6 days between treatments.

Sponsors

Canterbury Health Laboratories
Lead SponsorGovernment body

Study design

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

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Healthy Caucasian volunteers, with a normal fasting plasma homocysteine concentration.

Exclusion criteria

Vitamin B12 or folate deficiency, chronic or acute illness requiring prescription medication, current or previous history of vascular or renal disease, and smokers.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026