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Completed

NCT Number: NCT05624333

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University and Research

Wageningen, Gelderland, 6708 WE, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vegan diet (intervention)

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)

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.

Primary outcomes

  1. Muscle Protein Synthesis (MPS)

    Time frame: 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 outcomes

  1. Appetite

    Time frame: 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.

  2. Change in fasting plasma glucose

    Time frame: Change after 10 days of following each diet

    Fasting plasma glucose levels

  3. Change in fasting plasma insulin

    Time frame: Change after 10 days of following each diet

    Fasting plasma insulin levels

  4. Change in fasting plasma lipid profile

    Time frame: Change after 10 days of following each diet

    Triglycerides, high-density lipoprotein-cholesterol, low-density lipoprotein cholesterol, total cholesterol

  5. Change in blood pressure

    Time frame: Change after 10 days of following each diet

    Fasting systolic and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Maastricht University
  • Rijksoverheid

Registry information

Acronym: VD2O

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2022
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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