Effect of an Anti-ageing Supplement on Oxidative Stress

Healthy Volunteers Clinical Trial

— PromAge  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272867
• Other study ID #: 14TGO01
• Status: Completed
• Phase: N/A
• First received: September 2, 2017
• Last updated: September 2, 2017
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2017
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study serves to investigate whether ProManna intake leads to any changes in baseline levels for oxidative stress markers. In addition, biomarker responses following oxidative stress challenge tests will be assessed in subjects taking ProManna versus placebo supplements.

Description:

Ageing is characterized by a progressive decline in the efficiency of physiological function and by the increased susceptibility to disease and death. Most ageing-associated diseases develop silently for many years before symptoms appear, leading to irreversible pathological conditions. Examples of these diseases are Alzheimer's, Parkinson's, osteoporosis, diabetes, cardiovascular disease and also cancer. Typically, patients are treated when most of the damage has already occurred, and existing drugs can rarely cure these diseases, but merely slow down further progression of the disease. Therefore, preventive measures that may delay the onset of these diseases can hold the best promise for healthy ageing. of the most plausible and acceptable explanations for the mechanistic basis of aging is the "free radical theory of aging". This theory postulates that aging and its related diseases are the consequence of free radical-induced damage to cellular macromolecules and the inability to counterbalance these changes by endogenous anti-oxidant defences. ProManna is a novel and safe food supplement that aims to decrease free radical-induced damage, thereby contributing to healthy ageing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Healthy volunteer aged = 60 to = 70

2. Not involved in intensive sportive activities more than twice a week (e.g. playing football, tennis, running, cycling-racing, swimming)

3. Stable weight and no intention to lose weight until completion of the study (three times a day: a normal eating pattern).

4. Two weeks before the start and during the study no use of over the counter medication, prescribed medication, herbal medication or dietary supplements which in the investigator's opinion could affect study results, or which could be affected by the study product (i.e. absorption of oral medication will be influenced by D-Mannitol). Exception for sporadic use of paracetamol and/or treating an AE.

5. Able and motivated to comply with protocol requirements like for instance take the investigational product the way it is prescribed and to do the tests.

6. Voluntary signed written informed consent form (ICF) before the start of the pilot.

Exclusion Criteria:

1. BMI < 25 or > 30 kg/m2

2. Not being able to fast overnight (12 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

Related Conditions & MeSH terms

• Age Group: 60-70
• Healthy Volunteers
• Overweight

Intervention

Dietary Supplement:
• ProManna

Locations

Country	Name	City	State
Netherlands	UMCG	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in oxidative stress markers		Two weeks
Primary	Changes in oxidative stress following a hyperoxia or glucose challenge		Two weeks
Secondary	Changes in experienced health	Rand-36-item Health Survey (SF-36)	Two weeks