Back to resultsVegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O. (VD2O)
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Vegan diet (intervention)
Omnivorous diet (control)
Sponsored by
About this trial
This is an interventional supportive care trial for Sarcopenia
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.
Sites / Locations
- Wageningen University and Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
VO group
OV group
Arm Description
Vegan diet followed by Omnivorous diet
Omnivorous diet followed by Vegan diet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change in fasting plasma glucose
Fasting plasma glucose levels
Change in fasting plasma insulin
Fasting plasma insulin levels
Change in fasting plasma lipid profile
Triglycerides, high-density lipoprotein-cholesterol, low-density lipoprotein cholesterol, total cholesterol
Change in blood pressure
Fasting systolic and diastolic blood pressure
Full Information
NCT ID
NCT05624333
First Posted
November 8, 2022
Last Updated
March 23, 2023
Sponsor
Wageningen University
Collaborators
Rijksoverheid, Maastricht University
1. Study Identification
Unique Protocol Identification Number
NCT05624333
Brief Title
Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.
Acronym
VD2O
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
February 13, 2023 (Actual)
Study Completion Date
February 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University
Collaborators
Rijksoverheid, Maastricht University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VO group
Arm Type
Other
Arm Description
Vegan diet followed by Omnivorous diet
Arm Title
OV group
Arm Type
Other
Arm Description
Omnivorous diet followed by Vegan diet
Intervention Type
Other
Intervention Name(s)
Vegan diet (intervention)
Intervention Description
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
Intervention Name(s)
Omnivorous diet (control)
Intervention Description
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 Outcome Measure Information:
Title
Muscle Protein Synthesis (MPS)
Description
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.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Appetite
Description
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.
Time Frame
Measured daily for 10 days during each diet
Title
Change in fasting plasma glucose
Description
Fasting plasma glucose levels
Time Frame
Change after 10 days of following each diet
Title
Change in fasting plasma insulin
Description
Fasting plasma insulin levels
Time Frame
Change after 10 days of following each diet
Title
Change in fasting plasma lipid profile
Description
Triglycerides, high-density lipoprotein-cholesterol, low-density lipoprotein cholesterol, total cholesterol
Time Frame
Change after 10 days of following each diet
Title
Change in blood pressure
Description
Fasting systolic and diastolic blood pressure
Time Frame
Change after 10 days of following each diet
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisette de Groot
Organizational Affiliation
Wageningen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wageningen University and Research
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6708 WE
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.
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