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Twins Nutrition Study (TwiNS): Vegan vs. Omnivore (TwiNS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05297825
Recruitment Status : Completed
First Posted : March 28, 2022
Last Update Posted : January 12, 2024
Sponsor:
Information provided by (Responsible Party):
Christopher Gardner, Stanford University

Study Description
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Brief Summary:
This study is designed to investigate the health impact of a vegan diet compared to a usual, omnivorous diet. The investigators plan to study these diets in twins, where one twin follows a vegan diet and the other twin follows an omnivorous diet, thus the investigators control for genetic differences that might impact the effect of the diet.

Condition or disease Intervention/treatment Phase
Lipid Metabolism Glucose Intolerance Weight Change, Body Microbiome Inflammation Immune Function Behavioral: Vegan diet Behavioral: Omnivore diet Not Applicable

Detailed Description:
During this study, the investigators will evaluate the nutrient intake in both the vegan and the omnivorous diet. The investigators will also measure physiologic markers of health such as lipid levels, HbA1C, heart rate, and weight, and they will also look at the effect of the diets on the microbiota. In addition to measuring the effect of the diet, the investigators will monitor adherence to the diet, and survey participants on the ease/difficulty in following a vegan diet as well as their energy levels and sense of wellbeing. Thus, this study will help us better understand the health impact and feasibility of following a vegan diet. These results will be of much interest to the general public and the health care professionals.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Twins Nutrition Study (TwiNS): Vegan vs. Omnivore
Actual Study Start Date : March 17, 2022
Actual Primary Completion Date : July 20, 2022
Actual Study Completion Date : July 20, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Vegan
Participants will be asked to consume a healthy vegan diet.
 Behavioral: Vegan diet
Healthy vegan diet.
Experimental: Omnivore
Participants will be asked to consume a healthy omnivore diet.
 Behavioral: Omnivore diet
Healthy omnivore diet.


Outcome Measures
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Primary Outcome Measures :
  1. Difference in LDL cholesterol [ Time Frame: Baseline and 8 weeks ]
    Difference in the 8-week change-from-baseline in LDL cholesterol between the vegan vs. omnivore diet groups


Secondary Outcome Measures :
  1. Difference in triglycerides [ Time Frame: Baseline and 8 weeks ]
    Difference in the 8-week change-from-baseline in triglycerides between the vegan vs. omnivore diet groups

  2. Change in inflammatory markers [ Time Frame: Baseline and 8 weeks ]
    Difference in the 8-week change-from-baseline in inflammatory markers detected in blood samples between the vegan vs. omnivore diet groups.

  3. Change in alpha diversity [ Time Frame: Baseline and 8 weeks ]
    Change from baseline in alpha diversity at 8 weeks in the vegan and omnivore diet groups. We will be using the number of observed sequence variants ("species") determined by standard 16S rRNA amplicon sequencing (V3-V5 region followed by DADA2 to define error-corrected sequence variants) as our primary metric of alpha diversity. We will also determine whether there is a change in observed sequence variants between the two groups. Higher alpha diversity is better. The units are the number of sequence variants.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18+
  • 1/2 of a pair of twins that will both be participating
  • Willing to consume a plant-based diet (vegetables, fruit, whole grains, legumes, etc.)
  • Willing to consume meat/eggs (beef, pork/sausage, chicken, eggs) >= 1 time a day
  • Willing to consume dairy (milk, yogurt, cheese) >= 1 time a day

Exclusion Criteria:

  • Weight < 110 lb
  • BMI >= 40
  • LDL-C > 190 mg/dL
  • Systolic Blood Pressure > 160 mmHg OR Diastolic blood pressure > 90 mmHg
  • Pregnant, lactating or planning to become pregnant during the course of the study.

  • Use of any of the following drugs/supplements within the last 2 months:

    • systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);
    • corticosteroids (intravenous, intramuscular, oral, nasal or inhaled);
    • cytokines;
    • methotrexate or immunosuppressive cytotoxic agents.
  • Chronic, clinically significant, or unstable (unresolved, requiring on-going changes to medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history, Type 1 diabetes, dialysis
  • History of active cancer in the past 3 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision
  • Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
  • Recent history of chronic excessive alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day; or > 14 drinks/week.
  • Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection, multiple sclerosis and Graves' disease.
  • Surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
  • Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products
  • Regular use of prescription opiate pain medication
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05297825


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Christopher D Garnder, PhD Stanford University
More Information
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Additional Information:

Publications:

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Responsible Party: Christopher Gardner, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT05297825    
Other Study ID Numbers: 63995
First Posted: March 28, 2022    Key Record Dates
Last Update Posted: January 12, 2024
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Gardner, Stanford University:
Lipids
Glucose
Body weight
 Microbiome
Inflammation
Immune function
Additional relevant MeSH terms:
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Glucose Intolerance
Inflammation
Body Weight Changes
Pathologic Processes
 Body Weight
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases