NCT05809466Befejeződött
The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. ápr. 1.
Rövid összefoglaló (regiszter, angolul)
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, is a well-known strategy 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. As such, the current study aims to assess 1) 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 2) 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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 72 (tényleges)
- Első benyújtás
- 2023. márc. 14.
- Kezdés
- 2023. ápr. 4.
- Elsődleges befejezés
- 2024. szept. 26.
- Fő szponzor
- Wageningen University
- Betegségek
- Csontritkulás
- NCT-szám
- NCT05809466
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 72
- 2023. ápr. 4. és az elsődleges befejezés (2024. szept. 26.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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 (<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;
- Chronic use of medication that affects muscle function as assessed by the research physician;
- Having a contra-indication to MRI scanning (including, but not limited to):
- Pacemakers and defibrillators
- Infraorbital or intraocular metallic fragments
- Ferromagnetic implants
- Claustrophobia
- Currently a research participant in another trial or participated in a clinical trial during one month before the start of the measurement period;
Más betegség
- Being diagnosed with one of the following: diabetes mellitus; renal disease; 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.
Laborértékek
- 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;
Egyéb
- Having a hip prosthesis
- 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;
- Not being able to understand Dutch;
- Not having a general physician;
- Working, or having a direct family member that work 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.
Kiket keres a vizsgálat
- 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;
Életkor a regiszterben: 65 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Wageningen University and Research | Wageningen | Hollandia | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.