Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O. (VD2O)

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Other: Vegan diet (intervention); Other: Omnivorous diet (control)

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WE
      • Wageningen University and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 79 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: VO group; Vegan diet followed by Omnivorous diet	Other: 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.; 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.
Other: OV group; Omnivorous diet followed by Vegan diet	Other: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Protein Synthesis (MPS)	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.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appetite	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.	Measured daily for 10 days during each diet
Change in fasting plasma glucose	Fasting plasma glucose levels	Change after 10 days of following each diet
Change in fasting plasma insulin	Fasting plasma insulin levels	Change after 10 days of following each diet
Change in fasting plasma lipid profile	Triglycerides, high-density lipoprotein-cholesterol, low-density lipoprotein cholesterol, total cholesterol	Change after 10 days of following each diet
Change in blood pressure	Fasting systolic and diastolic blood pressure	Change after 10 days of following each diet

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: Maastricht University; Rijksoverheid
• Investigators: Principal Investigator: Lisette de Groot, Wageningen University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): February 13, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: NL82653.028.22; NL9542 (Registry Identifier: Netherlands Trial Register); NL76916.028.21 (Other Identifier: METC Brabant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No