Twins Nutrition Study (TwiNS): Vegan vs. Omnivore

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lipid Metabolism, Glucose Intolerance, Weight Change, Body, Microbiome, Inflammation, Immune Function

Intervention / Treatment
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* Behavioral: Vegan diet
* Behavioral: Omnivore diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vegan<br>Participants will be asked to consume a healthy vegan diet. | Behavioral: Vegan diet<br>* Healthy vegan diet.<br>|
| Experimental: Omnivore<br>Participants will be asked to consume a healthy omnivore diet. | Behavioral: Omnivore diet<br>* Healthy omnivore diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in LDL cholesterol | Difference in the 8-week change-from-baseline in LDL cholesterol between the vegan vs. omnivore diet groups | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in triglycerides | Difference in the 8-week change-from-baseline in triglycerides between the vegan vs. omnivore diet groups | Baseline and 8 weeks | 
| Change in inflammatory markers | Difference in the 8-week change-from-baseline in inflammatory markers detected in blood samples between the vegan vs. omnivore diet groups. | Baseline and 8 weeks | 
| Change in alpha diversity | 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. | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipids, Glucose, Body weight, Microbiome, Inflammation, Immune function