Cross-over randomized placebo-controlled pilot study to determine the effect in healthy elderly volunteers of the anti-ageing supplement *Promanna** on a number of biomarkers associated with DNA-damage and oxidative stress (PromAge)

Cross-over randomized placebo-controlled pilot study to determine the effect in healthy elderly volunteers of the anti-ageing supplement *Promanna** on a number of biomarkers associated with DNA-damage and oxidative stress (PromAge) - Effect of an anti-ageing supplement on oxidative stress

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40413

Enrollment

Registered

2014-09-30

Start date

2014-09-30

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Niet van toepassing, het gaat om gezonde vrijwilligers. NA (this is about healthy ageing)

Interventions

Use of ProManna for two weeks.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Healthy volunteer aged >= 60 to

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. BMI 30 kg/m2 2. Not being able to fast overnight (8 hours) 3. Diabetes mellitus 4. Gastrointestinal disorders 5. Undergone digestive tract surgery (except appendectomy) 6. Clinically significant inflammatory disease (possibly interfering with measurement of parameters in this study) 7. Weed smoking 8. Donation of blood within the last 3 months prior to admission to the clinic 9. Participation to another clinical study within 90 days before enrolment 10. Clinically relevant abnormalities in clinical chemistry or positive HIV, HbsAg and/or HepC at screening 11. Positive drug screen or alcohol breath test at D-1

Design outcomes

Primary

Measure	Time frame
The main study parameters are: • Changes in baseline levels for oxidative stress markers following 2 weeks intake of ProManna versus placebo • Comparison of oxidative stress responses following a hyperoxia or glucose challenge in subjects taking ProManna or placebo.	—

Secondary

Measure	Time frame
Results from questionnaires and biomarker studies will be used to design a long-term intervention study that will investigate the effect of ProManna on physical and mental parameters.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)