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

Primary Purpose

Lipid Metabolism, Glucose Intolerance, Weight Change, Body

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vegan diet

Omnivore diet

About this trial

This is an interventional prevention trial for Lipid Metabolism focused on measuring Lipids, Glucose, Body weight, Microbiome, Inflammation, Immune function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Vegan

Omnivore

Arm Description

Participants will be asked to consume a healthy vegan diet.

Participants will be asked to consume a healthy omnivore diet.

Outcomes

Primary Outcome Measures

Difference in LDL cholesterol

Difference in the 8-week change-from-baseline in LDL cholesterol between the vegan vs. omnivore diet groups

Secondary Outcome Measures

Difference in triglycerides

Difference in the 8-week change-from-baseline in triglycerides between the vegan vs. omnivore diet groups

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.

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.

Full Information

NCT ID

NCT05297825

First Posted

March 17, 2022

Last Updated

August 11, 2022

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT05297825

Brief Title

Twins Nutrition Study (TwiNS): Vegan vs. Omnivore

Acronym

TwiNS

Official Title

Twins Nutrition Study (TwiNS): Vegan vs. Omnivore

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

March 17, 2022 (Actual)

Primary Completion Date

July 20, 2022 (Actual)

Study Completion Date

July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Lipids, Glucose, Body weight, Microbiome, Inflammation, Immune function

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vegan

Arm Type

Experimental

Arm Description

Participants will be asked to consume a healthy vegan diet.

Arm Title

Omnivore

Arm Type

Experimental

Arm Description

Participants will be asked to consume a healthy omnivore diet.

Intervention Type

Behavioral

Intervention Name(s)

Vegan diet

Intervention Description

Healthy vegan diet.

Intervention Type

Behavioral

Intervention Name(s)

Omnivore diet

Intervention Description

Healthy omnivore diet.

Primary Outcome Measure Information:

Title

Difference in LDL cholesterol

Description

Difference in the 8-week change-from-baseline in LDL cholesterol between the vegan vs. omnivore diet groups

Time Frame

Baseline and 8 weeks

Secondary Outcome Measure Information:

Title

Difference in triglycerides

Description

Difference in the 8-week change-from-baseline in triglycerides between the vegan vs. omnivore diet groups

Time Frame

Baseline and 8 weeks

Title

Change in inflammatory markers

Description

Difference in the 8-week change-from-baseline in inflammatory markers detected in blood samples between the vegan vs. omnivore diet groups.

Time Frame

Baseline and 8 weeks

Title

Change in alpha diversity

Description

Time Frame

Baseline and 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher D Garnder, PhD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://med.stanford.edu/nutrition/research/current-studies/twins.html

Description

Study description and screening survey

Learn more about this trial

Twins Nutrition Study (TwiNS): Vegan vs. Omnivore

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