Effectiveness and Efficacy of a Ketogenic or Carnivore (Lion) Diet for Quality Life and Symptom Burden in Individuals With Symptomatic Inflammatory Bowel Disease or Rheumatoid Arthritis: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36)
研究概览
简要总结
This study is a randomized controlled clinical trial evaluating whether two therapeutic dietary approaches - a ketogenic diet and a carnivore (lion) diet - can improve quality of life, reduce symptoms, and influence measures of disease activity in adults with inflammatory bowel disease [ulcerative colitis and Crohn's disease] (IBD) or rheumatoid arthritis (RA).
Participants will be randomized into one of three groups: 1) Ketogenic Diet, 2) Carnivore (Lion) Diet or 3) Wait-List Control.
Participants randomized to a dietary group (ketogenic diet or carnivore diet) will be provided guidance on their specific dietary therapy and answer questions about their symptoms and quality of life at different intervals over a 24 week period. Participants will also complete laboratory testing at different intervals to assess for changes in nutritional status, cardiometabolic health and markers of immune activation and inflammation.
Participants initially placed on the wait-list group will be asked similar questions about their symptoms and quality of life and complete the same laboratory testing as participants in a dietary group. Participants on the wait list will then be compared to participants following a specific dietary pattern to assess for any differences between the 2 groups. After 12 weeks, participants on the wait list will be randomized to a dietary group (ketogenic diet or carnivore diet) and followed in a similar fashion for an additional 12 week period.
详细描述
The primary goal of this study is to determine whether ketogenic or carnivore dietary therapy improves, health-related quality of life, disease specific symptom burden or objective inflammatory markers in patients with a history of IBD or RA.
Given the limited prospective data on carnivore (lion) diet approaches for addressing autoimmune conditions, the study aims to assess feasibility of implementation as well as overall safety including the documentation of common adverse events, changes to nutritional status or changes to cardiometabolic status including blood lipids.
Total participation time is approximately 27 weeks including a 3-week baseline run-in and a 24-week dietary intervention period divided into 2, 12-week phases.
Randomization and 3 week run-in period
Participants will be randomized in a 2-2-2 schema, stratified by disease state (IBD or RA), to the carnivore (lion) diet, ketogenic diet, or placed on a wait-list. Participants will receive an at-home blood ketone and blood glucose monitoring device and a digital body composition scale. Participants will discontinue any supplements started within one month of study enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with medically verifiable IBD or medically verifiable RA
- •Current personal residence in the continental U.S.
- •Willingness and ability to follow dietary protocols
排除标准
- •Inability to provide consent
- •Individuals with Type 1 or Type II Diabetes on prescription medications including insulin
- •Outside of the age or BMI criteria
- •No medically definitive or verifiable diagnosis of IBD or RA
- •History of strictures or fistula (IBD)
- •History of blood transfusion in the previous 6 months
- •Pregnancy
- •6 months Postpartum
- •Breastfeeding
- •On other medications outside of FDA approved medications
- •Current initiation of disease modifying or biologic medication within the past 2 months
- •Unable to complete, for any reason, the initial 3-week run-in period prior to the beginning of the formal study intervention
- •Non-English Speaking
- •Organ failure of any kind including heart, liver and kidney failure or disease
- •History of malignancy within the last year prior to enrollment
- •Red meat allergy, alpha-gal allergy
研究组 & 干预措施
Ketogenic Diet 24 Weeks
Participants with IBD or RA randomized initially to receive dietary counseling regarding the ketogenic diet for up to 24 weeks
干预措施: Ketogenic diet (Behavioral)
Carnivore (Lion) Diet 24 Weeks
Participants with IBD or RA randomized initially to receive dietary counseling regarding the carnivore (lion) diet for up to 24 weeks
干预措施: Carnivore (Lion) Diet (Behavioral)
Ketogenic Diet for 12 Weeks AFTER Wait-List
Participants with IBD or RA randomized initially to the wait-list for 12 weeks who are then randomized to receive dietary counseling regarding the carnivore (lion) diet for a subsequent 12 weeks
干预措施: Ketogenic diet (Behavioral)
Voluntary Crossover - Carnivore (Lion) Diet to Ketogenic Diet AFTER 12 weeks
Participants with IBD or RA randomized initially to the carnivore (lion) diet for 12 weeks who voluntarily choose to crossover to the ketogenic diet intervention for the final 12 weeks
干预措施: Ketogenic diet (Behavioral)
Wait List 12 Weeks
Participants with IBD or RA randomized initially to a 12 week waitlist who will continue their baseline dietary pattern WITHOUT specific dietary guidance/intervention
Carnivore (Lion) Diet for 12 weeks AFTER Wait-List
Participants with IBD or RA randomized initially to the wait-list for 12 weeks who are then randomized to receive dietary counseling regarding the carnivore (lion) diet for a subsequent 12 weeks
干预措施: Carnivore (Lion) Diet (Behavioral)
Voluntary Crossover - Ketogenic Diet to Carnivore (Lion) Diet AFTER 12 weeks
Participants with IBD or RA randomized initially to the ketogenic diet for 12 weeks who voluntarily choose to crossover to the carnivore (lion) diet intervention for the final 12 weeks
干预措施: Ketogenic diet (Behavioral)
Voluntary Crossover - Ketogenic Diet to Carnivore (Lion) Diet AFTER 12 weeks
Participants with IBD or RA randomized initially to the ketogenic diet for 12 weeks who voluntarily choose to crossover to the carnivore (lion) diet intervention for the final 12 weeks
干预措施: Carnivore (Lion) Diet (Behavioral)
Voluntary Crossover - Carnivore (Lion) Diet to Ketogenic Diet AFTER 12 weeks
Participants with IBD or RA randomized initially to the carnivore (lion) diet for 12 weeks who voluntarily choose to crossover to the ketogenic diet intervention for the final 12 weeks
干预措施: Carnivore (Lion) Diet (Behavioral)
结局指标
主要结局
Change in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36)
时间窗: From baseline to 24 weeks
The SF-36 consists of 8 subscales including: physical functioning, role limitations due to physical health (physical role functioning), role limitations due to emotional problems (emotional role functioning), vitality, mental health, social role functioning, bodily pain and general health. Scores for each subscale will be on a 0-100 scale with higher scores generally reflecting better health or less functional impairment for that respective subscale.
Change in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36)
时间窗: From baseline to 12 weeks
The SF-36 consists of 8 subscales including: physical functioning, role limitations due to physical health (physical role functioning), role limitations due to emotional problems (emotional role functioning), vitality, mental health, social role functioning, bodily pain and general health. Scores for each subscale will be on a 0-100 scale with higher scores generally reflecting better health or less functional impairment for that respective subscale.
次要结局
- Change in Rheumatoid Arthritis Disease Activity Index-5 Questionnaire (RADAI-5)(From baseline to 12 and 24 weeks)
- Change in Routine Assessment of Patient Index Data (RAPID-3)(From baseline to 12 and 24 weeks)
- Change in Inflammatory Bowel Disease Symptom Inventory - Short Form (IBDSI-SF)(From baseline to 12 and 24 weeks)
- Change in fecal calprotectin(From baseline to 12 and 24 weeks)
- Change in immune and inflammatory serology(From baseline to 12 and 24 weeks)
- Change in point of care (at-home) blood ketones (beta-hydroxybutyrate)(From baseline to the end of the study intervention at 24 weeks)
- Change in point of care (at-home) blood glucose(From baseline to the end of the study intervention at 24 weeks)