Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.

NCT ID: NCT05624333

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2023-02-13

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

VO group

Vegan diet followed by Omnivorous diet

Group Type: OTHER

Vegan diet (intervention)

Intervention Type: OTHER

The intervention diet will be a fully controlled vegan diet that will be consumed for a duration of 10 days. No animal-based food products will be included in the diet.

Omnivorous diet (control)

Intervention Type: OTHER

The control diet will be an a priori composed controlled omnivorous diet with a duration of 10 days. The omnivorous diet and the vegan diet will be isocaloric and isonitrogenous.

OV group

Omnivorous diet followed by Vegan diet

Group Type: OTHER

Vegan diet (intervention)

Intervention Type: OTHER

The intervention diet will be a fully controlled vegan diet that will be consumed for a duration of 10 days. No animal-based food products will be included in the diet.

Omnivorous diet (control)

Intervention Type: OTHER

The control diet will be an a priori composed controlled omnivorous diet with a duration of 10 days. The omnivorous diet and the vegan diet will be isocaloric and isonitrogenous.

Interventions

Vegan diet (intervention)

The intervention diet will be a fully controlled vegan diet that will be consumed for a duration of 10 days. No animal-based food products will be included in the diet.

Intervention Type: OTHER

Omnivorous diet (control)

The control diet will be an a priori composed controlled omnivorous diet with a duration of 10 days. The omnivorous diet and the vegan diet will be isocaloric and isonitrogenous.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rijksoverheid

UNKNOWN

Sponsor Role: collaborator

Maastricht University

OTHER

Sponsor Role: collaborator

Wageningen University

OTHER

Sponsor Role: lead

Responsible Party

Lisette de Groot

Prof. Dr. Ir. L.C.P.G.M. (Lisette) de Groot

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisette de Groot

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

Wageningen University and Research

Wageningen, Gelderland, Netherlands

Countries

Netherlands

References

Domic J, Pinckaers PJ, Grootswagers P, Siebelink E, Gerdessen JC, van Loon LJ, de Groot LC. A Well-Balanced Vegan Diet Does not Compromise Daily Mixed Muscle Protein Synthesis Rates when Compared with an Omnivorous Diet in Active Older Adults: A Randomized Controlled Cross-Over Trial. J Nutr. 2025 Apr;155(4):1141-1150. doi: 10.1016/j.tjnut.2024.12.019. Epub 2024 Dec 26.

Reference Type: DERIVED

PMID: 39732437 (View on PubMed)

Other Identifiers

NL9542

Identifier Type: REGISTRY

Identifier Source: secondary_id

NL76916.028.21

Identifier Type: OTHER

Identifier Source: secondary_id

NL82653.028.22

Identifier Type: -

Identifier Source: org_study_id