Clinical trial NCT05624333: Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.
Official title: Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Rijksoverheid
name: Maastricht University
First posted: 2022-11-22
Enrollment: 38
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Consumers are increasingly encouraged to consume more plant-based foods and lower their consumption of foods from animal origin. 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 sarcopenia is highly prevalent. The aim of this randomized controlled cross-over study is to investigate the short-term effect of a 10-day controlled vegan diet on daily muscle fractional synthesis rates in comparison to a 10-day controlled omnivorous diet in 35 community-dwelling older adults.

Participants will follow a fully controlled vegan diet, directly followed by a fully controlled omnivorous diet for 10 days, or vice versa. Researchers will compare the effect of the vegan diet to the effect of the omnivorous diet.


Eligibility criteria: Inclusion Criteria:

* Aged 65-79 years old;
* Community-dwelling;
* BMI 20-35 kg/m\^2.

Exclusion Criteria:

* Following a vegetarian or vegan diet during the six months prior to the study;
* Following a diet that affects protein intake during the six months prior to the study;
* Participating in a structured exercise training program in the past three months;
* 5% or more body weight loss during three months before the start of the study;
* Being diagnosed with one of the following: diabetes; renal disease; neurological or neuromuscular disorders; serious cardiovascular diseases; cancer; chronic obstructive lung disease (COPD);
* Chronic use of medication that affects muscle function, e.g. corticosteroids, metformin, insulin;
* The use of the following medicines: acenocoumarol (sintrom); phenprocoumon (marcoumar); dabigatran (pradaxa); apixaban (eliquis); rivaroxaban (xarelto); clopidogrel (plavix); combination of acetylsalicylic acid or carbasalate calcium (ascal) with dipyridamole.
* Allergic or intolerant to any product included in the diets;
* Not willing to stop nutritional supplements, with the exception of supplements on medical advice, and vitamin D;
* Not willing or afraid to give blood or undergo a muscle biopsy during the study;
* Unwilling to eat a vegan and an omnivorous diet for ten days each;
* Currently a research participant in another trial or participated in a clinical trial during three months before the start of the measurement period;
* Not being able to understand Dutch;
* Not having a general physician.

Primary outcomes:
measure: Muscle Protein Synthesis (MPS)
timeFrame: 10 days
Secondary outcomes:
measure: Appetite
timeFrame: Measured daily for 10 days during each diet
measure: Change in fasting plasma glucose
timeFrame: Change after 10 days of following each diet
measure: Change in fasting plasma insulin
timeFrame: Change after 10 days of following each diet
measure: Change in fasting plasma lipid profile
timeFrame: Change after 10 days of following each diet
measure: Change in blood pressure
timeFrame: Change after 10 days of following each diet
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University and Research
state: Gelderland
Study officials:
affiliation: Wageningen University
name: Lisette de Groot
role: PRINCIPAL_INVESTIGATOR
References: