Twins Nutrition Study (TwiNS): Vegan vs. Omnivore

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT05297825
Collaborator
(none)
44
1
2
4.1
10.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Vegan diet
  • Behavioral: Omnivore diet
N/A

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

Study Type:
Interventional
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 :
Mar 17, 2022
Actual Primary Completion Date :
Jul 20, 2022
Actual Study Completion Date :
Jul 20, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Difference in LDL cholesterol [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Stanford University Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Christopher D Garnder, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Christopher Gardner, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier:
NCT05297825
Other Study ID Numbers:
  • 63995
First Posted:
Mar 28, 2022
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christopher Gardner, Principal Investigator, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022