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Effect of an Anti-ageing Supplement on Oxidative Stress (PromAge)

Primary Purpose

Healthy Volunteers, Age Group: 60-70, Overweight

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

ProManna

About this trial

This is an interventional prevention trial for Healthy Volunteers

Eligibility Criteria

60 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy volunteer aged ≥ 60 to ≤ 70
Not involved in intensive sportive activities more than twice a week (e.g. playing football, tennis, running, cycling-racing, swimming)
Stable weight and no intention to lose weight until completion of the study (three times a day: a normal eating pattern).
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.
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.
Voluntary signed written informed consent form (ICF) before the start of the pilot.

Exclusion Criteria:

BMI < 25 or > 30 kg/m2
Not being able to fast overnight (12 hours)
Diabetes mellitus
Gastrointestinal disorders
Undergone digestive tract surgery (except appendectomy)
Clinically significant inflammatory disease (possibly interfering with measurement of parameters in this study)
Weed smoking
Donation of blood within the last 3 months prior to admission to the clinic
Participation to another clinical study within 90 days before enrolment
Clinically relevant abnormalities in clinical chemistry or positive HIV, HbsAg and/or HepC at screening
Positive drug screen or alcohol breath test at D-1

Sites / Locations

UMCG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

One group of volunteers will ingest a powder with dose of 6.1 g ProManna twice a day for a period of 2 weeks

Another group of volunteers will ingest a powder with the same amount of a placebo twice a day for a periode of 2 weeks

Outcomes

Primary Outcome Measures

Changes in oxidative stress markers

Changes in oxidative stress following a hyperoxia or glucose challenge

Secondary Outcome Measures

Changes in experienced health

Rand-36-item Health Survey (SF-36)

Full Information

NCT ID

NCT03272867

First Posted

September 2, 2017

Last Updated

September 2, 2017

Sponsor

University Medical Center Groningen

1. Study Identification

Unique Protocol Identification Number

NCT03272867

Brief Title

Effect of an Anti-ageing Supplement on Oxidative Stress

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

December 2014 (Actual)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Medical Center Groningen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers, Age Group: 60-70, Overweight

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

One group of volunteers will ingest a powder with dose of 6.1 g ProManna twice a day for a period of 2 weeks

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Another group of volunteers will ingest a powder with the same amount of a placebo twice a day for a periode of 2 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

ProManna

Other Intervention Name(s)

L-proline, D-mannitol

Primary Outcome Measure Information:

Title

Changes in oxidative stress markers

Time Frame

Two weeks

Title

Changes in oxidative stress following a hyperoxia or glucose challenge

Time Frame

Two weeks

Secondary Outcome Measure Information:

Title

Changes in experienced health

Description

Rand-36-item Health Survey (SF-36)

Time Frame

Two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy volunteer aged ≥ 60 to ≤ 70 Not involved in intensive sportive activities more than twice a week (e.g. playing football, tennis, running, cycling-racing, swimming) Stable weight and no intention to lose weight until completion of the study (three times a day: a normal eating pattern). 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. 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. Voluntary signed written informed consent form (ICF) before the start of the pilot. Exclusion Criteria: BMI < 25 or > 30 kg/m2 Not being able to fast overnight (12 hours) Diabetes mellitus Gastrointestinal disorders Undergone digestive tract surgery (except appendectomy) Clinically significant inflammatory disease (possibly interfering with measurement of parameters in this study) Weed smoking Donation of blood within the last 3 months prior to admission to the clinic Participation to another clinical study within 90 days before enrolment Clinically relevant abnormalities in clinical chemistry or positive HIV, HbsAg and/or HepC at screening Positive drug screen or alcohol breath test at D-1

Facility Information:

Facility Name

UMCG

City

Groningen

ZIP/Postal Code

9700RB

Country

Netherlands

12. IPD Sharing Statement

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Effect of an Anti-ageing Supplement on Oxidative Stress

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