Primary: To assess the effects of a 12-week self-composed vegan diet in comparison to an omnivorous diet on thigh muscle volume (TMV) in community-dwelling older adults. And to assess the effect of a 12-week self-composed vegan diet combined with…
ID
Source
Brief title
Condition
- Other condition
- Bone, calcium, magnesium and phosphorus metabolism disorders
- Muscle disorders
Synonym
Health condition
Preventie cardiometabole aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in change in TMV.
Secondary outcome
- Other body composition indices from MRI-scan: thigh muscle fat infiltration,
liver proton-density fat fraction, visceral adipose tissue, Abdominal
subcutaneous adipose tissue
- Muscle strength
- Muscle fractional synthesis rates
- Bone mineral density
- Bone turnover markers (C-terminal telopeptide of type I collagen [CTX] and
procollagen type I N-terminal propeptide [PINP])
- Insulin-like growth factor 1 (IGF-1) and parathyroid hormone (PTH) levels
- Insulin levels
- Dietary intake
- Metabolic profile
- Blood pressure
- Iron status
- Vitamin B12 status
- Vitamin D status
- Gastrointestinal symptoms
- Gut metabolomics and metagenomics
- High sensitive CRP
- DNA methylation
Background summary
Consumers are increasingly encouraged to consume more plant-based foods and
lower their consumption of foods from animal origin. This shift is driven by
environmental and health factors. However, the consequences of such a
transition on muscle mass still remains to be explored. This is of particular
importance in the older population, where the age-related reduction in muscle
mass and strength is highly prevalent. Adequate dietary intake, specifically
protein intake, and resistance exercise are well-known strategies in promoting
muscle mass in older adults. Plant-based foods are currently considered to be
inferior to animal-based foods in their protein quality, and are therefore
considered to be suboptimal for the maintenance of muscle mass at an older age.
On the other hand, combining plant-based foods may improve the protein quality
and thereby the anabolic properties of a vegan meal. Evidence regarding the
anabolic properties of vegan diets in older adults is scarce.
Study objective
Primary: To assess the effects of a 12-week self-composed vegan diet in
comparison to an omnivorous diet on thigh muscle volume (TMV) in
community-dwelling older adults. And to assess the effect of a 12-week
self-composed vegan diet combined with twice-weekly resistance exercise (RE) on
TMV in comparison to a self-composed vegan diet without resistance exercise in
community-dwelling older adults.
Secondary:
To assess the effect of a 12-week self-composed vegan diet in comparison to an
omnivorous diet, and to assess the effect of a 12-week self-composed vegan diet
combined with twice weekly RE in comparison to a self-composed vegan diet
without RE on:
- Other body composition components
- Muscle strength
- Bone mineral density and bone turnover markers
- Cardiometabolic outcome measures
- Vitamin B12, vitamin D and iron status
- DNA methylation
To assess the effect of a 10-day self-composed vegan diet in comparison to an
omnivorous diet, and to assess the effect of a 10-day self-composed vegan diet
combined with twice weekly RE compared to a self-composed vegan diet without RE
on:
- Muscle protein synthesis
To assess the effect of a 12-week self-composed vegan diet in comparison to an
omnivorous diet on:
- Gastro-intestinal symptoms
- Gut metabolomics and metagenomics
To assess the nutritional value of a self-composed vegan diet in
community-dwelling older adults.
Study design
A randomized controlled intervention trial with three parallel study arms.
Intervention
Self-composed fully plant-based (vegan) diet with or without concurrent RE.
Study burden and risks
The risks of the study are minimal. The diets will be predominantly
self-composed by the participants. All products provided by the researchers are
commercially available. Only participants with a BMI of >=23 kg/m2, with no more
than 4 kg weight loss in the past 3 months will be included to minimize risks
related to a potential small decrease in muscle mass. The 12-w duration of the
vegan diet excludes the possible risk of vitamin B12 deficiency. Vitamin D
supplements will be advised to the participants to minimize the risk of vitamin
D deficiency, improve calcium absorption, and thereby minimize fracture risk.
Methods used to explore the effects of the intervention have been widely used
in other studies and will be performed according to standard operating
procedures (SOPs). The MRI-protocol used to assess the primary and secondary
outcomes is very short (6-10 minutes) and participants will be screened on
eligibility for MRI-scanning at screening and, again, prior to each
MRI-scanning session. No serious side effects have been previously observed
following the deuterated water protocol that will be used in this study.
Venipuncture and muscle biopsies will be performed by trained health care
professionals and may cause some discomfort, but further risks are minor.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
- Aged >=65 years old;
- Community-dwelling;
- BMI 23-32 kg/m2;
- Habitual diet contains animal-based food products (i.e. dairy, meat and/or
fish) at least 5 days per week;
Exclusion criteria
- Following a self-reported entirely vegetarian or vegan diet during the six
months prior to the study; - Following a prescribed high (>=1.2 g/kg/d) or low
protein diet (below 0.8 g/kg/d), and/or or taking protein supplements on
medical advice, during the month prior to the study; - Participating in a
structured progressive resistance exercise training program the during three
months prior to the study; - >=4 kg of body weight loss during three months
before the start of the study; - Being diagnosed with one of the following:
diabetes mellitus; severe renal disease (glomerular filtration rate below 30
ml/min) ; neurological or neuromuscular disorders; serious cardiovascular
diseases; cancer (with the exception of the following types of skin cancer:
basal cell carcinoma, squamous cell carcinoma); (very) severe chronic
obstructive lung disease (COPD; GOLD stage III or IV); bowel disease. - Chronic
use of medication that affects muscle function as assessed by the research
physician; - The use of anticoagulants incompatible for muscle biopsies as
assessed by the research physician: acenocoumarol (sintrom); phenprocoumon
(marcoumar); dabigatran (pradaxa); apixaban (eliquis); rivaroxaban (xarelto);
clopidogrel (plavix); edoxaban (lixiana); combination of acetylsalicylic acid
or carbasalate calcium (ascal) with dipyridamole; - Having a contra-indication
to MRI scanning (including, but not limited to): o Pacemakers and
defibrillators o Infraorbital or intraocular metallic fragments o Ferromagnetic
implants o Claustrophobia - Not willing to stop nutritional supplements, with
the exception of supplements on medical advice, and vitamin D; - Not willing or
afraid to give blood, undergo a muscle biopsy or have an MRI scan during the
study; - Unwilling to eat a self-composed vegan diet or an omnivorous diet with
daily consumption of animal-based food sources for 3 months; - Unwilling to
participate in RE twice a week for 3 months; - Currently a research participant
in another trial or participated in a clinical trial during one month before
the start of the measurement period; - Not being able to understand Dutch; -
Not having a general physician; - Working, or having a direct family member
that works at the Division of Human Nutrition at Wageningen University during
the study. - Unwilling to be informed about incidental findings of pathology
and approving of reporting this to their general physician.
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 | NL82788.091.22 |