The main objective of this study is to determine whether supplementation with FO combined with complex phospholipids can alter skeletal muscle mitochondrial function more effectively than FO alone. Additional exploratory objectives are;…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
veroudering, energiemetabolisme
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameters relate to the anticipated differences in
mitochondrial function and include ex vivo mitochondrial respiratory capacity
as the main study endpoint.
Secondary outcome
Resting energy metabolism, body composition, and physical and cognitive
function. Furthermore, markers of mitochondrial metabolism and mitochondrial
respiratory capacity in skeletal muscle tissue will be determined.
Background summary
Reduced mitochondrial membrane phospholipid content and unsaturation is
associated with aging, resulting in reduced mitochondrial function that
underlies age associated decrements in physical and cognitive function. Since
membrane phospholipids are diet modifiable, supplementation with omega-3 fish
oils (FO) and a phospholipid enriched dairy fat fraction (Cream serum powder;
CSP) may represent an effective, novel therapeutic strategy for enhancing
mitochondrial, physical, and cognitive function in aging.
Study objective
The main objective of this study is to determine whether supplementation with
FO combined with complex phospholipids can alter skeletal muscle mitochondrial
function more effectively than FO alone. Additional exploratory objectives are;
determination of 1) Skeletal muscle and physical function 2) body composition,
3) cognitive function, and 4) molecular pathways and gene transcription
responsible for improved mitochondrial health and function.
Study design
A multicentre, double-blind, randomised, controlled, parallel trial, where FO
plus CSP will be compared to FO with a calorie matched, phospholipid free lipid
mixture.
Intervention
FO (3g Total, 2.1g EPA & DHA) combined with 13g of either a CSP or with a
skimmed milk (75%) and palm oil powder (25%) (SMPO) mixture.
Study burden and risks
This study will lead to novel insights with respect to the ability of food
constituents to improve mitochondrial function and health in the elderly. The
major burden to the subjects is a time investment. Subjects will be asked to
attend the university on ~5 occasions for measurement procedures. Additionally,
subjects will consume FO capsules in combination with either CSP or SMPO daily
for 12 weeks. The experimental procedures present minimal risk, Local hematoma
or bruising can occur from IV insertion and muscle biopsy procedures. The risk
of infection or prolonged bleeding is low due to state-of-the-art techniques,
screening procedures, and sterility measures. In the event of coincidental
medical findings subjects will be informed and may be advised to contact a
doctor about this.
Universeteitssingel 50
Maastricht 6229ER
NL
Universeteitssingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
- Males and females;
- Caucasian;
- Age * 65 years;
- BMI * 20 kg/m2 * 30 kg/m2;
- Normal physical activity levels: maximum of 1 hour per week engagement in
moderate or high intensity structured exercise
- Subject should be in sufficient health to participate in the experiments, to
be judged by the site-specific responsible physician, based on the subject's
medical history.
Exclusion criteria
- Not meeting all inclusion criteria;
- Habitual smoker within the past 5 years;
- Excessive alcohol use (greater than 20g per day) and/or drug abuse;
- Subjects with diagnosed diabetes mellitus type 2;
- Significant food allergies or intolerances concerning the study products,
e.g. cow*s milk protein allergy
- Participation in another biomedical study within 1 month before the first
study visit, possibly interfering with the study results;
- Medication use known to hamper subject*s safety during the study procedures;
- Subjects habitually taking fish oil supplements within 3-months of the
initial study visit or habitually taking lipid supplements that are likely to
affect the main study outcomes;
- Subjects who do not want to be informed about unexpected medical findings;
- Subjects who do not want their treating physician to be informed about
unexpected medical findings;
- Inability to participate and/or complete the required measurements.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68966.068.19 |
| Other | volgt z.s.m. |