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

Not Applicable

Completed

• Conditions: Sarcopenia
• Interventions: Other: Vegan diet (intervention); Other: Omnivorous diet (control)

• Registration Number: NCT05624333
• Lead Sponsor: Wageningen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-22
• Study Start: 2023-01-09
• Primary Completion: 2023-02-13
• Study Completion: 2023-02-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VO group	Omnivorous diet (control)	Vegan diet followed by Omnivorous diet
VO group	Vegan diet (intervention)	Vegan diet followed by Omnivorous diet
OV group	Vegan diet (intervention)	Omnivorous diet followed by Vegan diet
OV group	Omnivorous diet (control)	Omnivorous diet followed by Vegan diet

Primary Outcome Measures

Name	Time	Method
Muscle Protein Synthesis (MPS)	10 days	MPS, expressed as daily fractional synthesis rates (FSR, %/day), will be assessed using a deuterium oxide protocol. Daily FSR will be calculated using the 2\^H-alanine enrichment in plasma and the mixed muscle-bound 2\^H-alanine enrichment.

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure	Change after 10 days of following each diet	Fasting systolic and diastolic blood pressure
Change in fasting plasma glucose	Change after 10 days of following each diet	Fasting plasma glucose levels
Change in fasting plasma insulin	Change after 10 days of following each diet	Fasting plasma insulin levels
Appetite	Measured daily for 10 days during each diet	Appetite will be assessed using visual analogue scales (VAS; Min 0 mm - max 100 mm) before and after the warm meal. Five VAS-scales regarding hunger, fullness, satiation, desire to eat and prospective food consumption will be used to assess appetite.
Change in fasting plasma lipid profile	Change after 10 days of following each diet	Triglycerides, high-density lipoprotein-cholesterol, low-density lipoprotein cholesterol, total cholesterol

Trial Locations

Locations (1)

Wageningen University and Research; 🇳🇱 Wageningen, Gelderland, Netherlands