Examining the Effects of Juice Fasting

NCT03647449 | Completed

• 1 other identifier: STU00206611
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests the effectiveness of dietary interventions that have the possibility to improve markers of gut health and improve general well-being. This study will allow healthcare professionals to learn how dietary interventions involving fasting can affect health. Food is increasingly recognized as a core component of preventive and ameliorative health care. Juice fasting has quickly become one of the most popular self-prescribed dietary interventions in the United States. A wide variety of juice fasts are available in the popular market; a popular variation is the three-day juice fast. The purpose of this study is to assess the effects of a three-day juice fast on certain markers of age-related disease and bio-markers of longevity. In particular, this study will assess certain epigenetic markers, which measure how the environment (including diet) can change the way that genes are expressed without changing the genes themselves. The study will also assess the microbiome, and inflammatory and glycemic markers.

Conditions

Epigenetics; Microbiome

Keywords

Juice fasting; methylation; microbiome; caloric restriction

Outcome Measures

Primary Outcomes (1)

• Change DNA Methylation at Day 7

  The ratio of methylated signal to total signal and the M-value (log2 ratio of methylated signal over unmethylated signal) will be determined for each interrogated locus using Illumina's Infinium Methylation EPIC BeadChip

  This outcome will be measured on day 7 of the study.

Secondary Outcomes (39)

• Baseline DNA Methylation

  This outcome will be measured on day 1 of the study.

• Change DNA Methylation at Day 4

  This outcome will be measured on day 4 of the study.

• Change DNA Methylation at Day 21

  This outcome will be measured on day 21 of the study.

• PROMIS Global Health self-report

  This outcome will be measured on day 1 of the study.

• PROMIS Global Health self-report, repeatable

  This outcome will be measured on day 4 of the study.

Study Arms (3)

Juice fast

EXPERIMENTAL

In the "juice fasting" arm, participants will be given vegetable/fruit pressed juices and be instructed to engage in a three-day juice fast diet totaling 800-900 kcal-per-day. The specific juices will be assigned for each day in order to maintain the calorie level.

Dietary Supplement: Juice; Behavioral: Caloric restriction via Plant-based meals

Caloric restriction via Plant-based meals

EXPERIMENTAL

In the "caloric restriction diet" arm, participants will be on a whole-food plant-based diet totaling 800-900 kcal-per-day (matching the daily calories of juice fasting).

Behavioral: Caloric restriction via Plant-based meals; Dietary Supplement: Plant-based meal

Juice plus ad hoc

EXPERIMENTAL

In the "juice plus ad hoc" arm, participants will be given the same juice for three days but continue with their usual diet in addition to the juice. For this arm, there is no restriction of caloric intake or restriction to liquid only.

Dietary Supplement: Juice

Interventions

Juice DIETARY_SUPPLEMENT

Participants will be drinking 800-900 kcal/day in cold-pressed juices.

Juice fast; Juice plus ad hoc

Caloric restriction via Plant-based meals BEHAVIORAL

Participants' caloric intake will be limited to 800-900 kcal/day.

Caloric restriction via Plant-based meals; Juice fast

Plant-based meal DIETARY_SUPPLEMENT

Participants will be eating \~900 kcal/day in pre-prepared plant-based meals.

Caloric restriction via Plant-based meals

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects considered as healthy by the investigator based on medical history and completion of the screening questionnaire.
• Subjects who, according to the investigator, can and will comply with the requirements of the protocol and are available for all scheduled visits at the investigational site.
• Healthy male or female aged between 18 and 35 (included) years
• ≤BMI ≤ 30 kg/m²
• Ability to give their informed consent in writing

You may not qualify if:

• Documented history of previous cardiovascular disease, including coronary heart disease (CHD) (angina, myocardial infarction, coronary revascularization procedures or existence of abnormal Q waves in the electrocardiogram (EKG)), stroke, syncope, and clinical peripheral artery disease with symptoms of intermittent claudication.
• Severe medical condition that may impair the ability of the person to participate in a nutrition intervention study (e.g. digestive disease with fat intolerance, advanced malignancy, or major neurological, psychiatric or endocrine disease including diabetes).
• Daily use of any prescription or non-prescription medication that has a high likelihood of impacting systemic inflammation (e.g. non-steroidal anti inflammatories or steroids), blood sugar control (e.g. medication for diabetes) or the human microbiome (e.g. antibiotics).
• Any other medical condition thought to limit survival to less than 1 year.
• Known immunodeficiency disorder
• Illegal drug use or chronic alcoholism or total daily alcohol intake \>80 g/d.
• Difficulties or major inconvenience to change dietary habits
• Impossibility to follow an elimination or juice fast diet, for religious reasons or due to the presence of disorders of chewing or swallowing (e.g., difficulties to consume nuts)
• A low predicted likelihood to change dietary habits according to the Prochaska and DiClemente stages of change model (Nigg, 1999).
• History of food allergy with hypersensitivity to any of the components of the juice or diet
• Patients with an acute infection or inflammation (e.g., pneumonia) are allowed to participate in the study 3 months after the resolution of their condition.
• Dietary restrictions due to medical (including allergies), religious, or other concerns
• Any diagnosis of allergic rhinitis, eczema, asthma, or inflammatory bowel disease (e.g. ulcerative colitis or Crohn's) from a health professional

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• Redman LM, Ravussin E. Caloric restriction in humans: impact on physiological, psychological, and behavioral outcomes. Antioxid Redox Signal. 2011 Jan 15;14(2):275-87. doi: 10.1089/ars.2010.3253. Epub 2010 Aug 28.

  PMID: 20518700 BACKGROUND

• Fontana L, Partridge L, Longo VD. Extending healthy life span--from yeast to humans. Science. 2010 Apr 16;328(5976):321-6. doi: 10.1126/science.1172539.

  PMID: 20395504 BACKGROUND

• Henning SM, Shao P, Qing-Yi L, Yang J, Huang J, Ru-Po L, Thames G, Heber D, Li Z. Health effects of 3-day fruit and vegetable juice fasting. Advanced Nutrition, 7(48A), 2016.

  BACKGROUND

• Rink SM, Mendola P, Mumford SL, Poudrier JK, Browne RW, Wactawski-Wende J, Perkins NJ, Schisterman EF. Self-report of fruit and vegetable intake that meets the 5 a day recommendation is associated with reduced levels of oxidative stress biomarkers and increased levels of antioxidant defense in premenopausal women. J Acad Nutr Diet. 2013 Jun;113(6):776-85. doi: 10.1016/j.jand.2013.01.019. Epub 2013 Mar 19.

  PMID: 23522825 BACKGROUND

• Zheng J, Zhou Y, Li S, Zhang P, Zhou T, Xu DP, Li HB. Effects and Mechanisms of Fruit and Vegetable Juices on Cardiovascular Diseases. Int J Mol Sci. 2017 Mar 4;18(3):555. doi: 10.3390/ijms18030555.

  PMID: 28273863 BACKGROUND

Study Officials

• Melinda Ring, MD, FACP

  Osher Center for Integrative Medicine at Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Medicine and Medical Social Sciences

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 27, 2018
• Study Start: July 10, 2018
• Primary Completion: March 11, 2019
• Study Completion: December 31, 2019
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

US (1)