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PREDICT 2: Personalized Responses to Dietary Composition Trial 2

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ClinicalTrials.gov Identifier: NCT03983733
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
Massachusetts General Hospital
Stanford University
King's College London
Tufts University
Information provided by (Responsible Party):
Zoe Global Limited

Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 25, 2019
Actual Study Start Date  ICMJE June 10, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2019)
  • Gut microbiome species richness [ Time Frame: 1 Day ]
    Species count in fecal sample
  • Lipids [ Time Frame: 3 days ]
    Measurement of blood lipids
  • Glucose [ Time Frame: 11 days ]
    Measurement of blood glucose
  • Sleep [ Time Frame: 10 days ]
    Record of sleep pattern using a wearable device (i.e. fitness watch)
  • Physical activity [ Time Frame: 10 days ]
    Record of physical activity using a wearable device (i.e. fitness watch)
  • Hunger and appetite assessment [ Time Frame: 10 days ]
    Record of hunger and appetite patterns using a digital app
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Gut microbiome species richness [ Time Frame: 1 month ]
    Species count in fecal sample
  • Lipids [ Time Frame: 3 days ]
    Measurement of blood lipids
  • Glucose [ Time Frame: 12 days ]
    Measurement of blood glucose
  • Sleep [ Time Frame: 12 days ]
    Record of sleep pattern using a wearable device (i.e. fitness watch)
  • Physical activity [ Time Frame: 12 days ]
    Record of physical activity using a wearable device (i.e. fitness watch)
  • Hunger and appetite assessment [ Time Frame: 12 days ]
    Record of hunger and appetite patterns using a digital app
Change History Complete list of historical versions of study NCT03983733 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2019)
  • Glucose metabolism [ Time Frame: 3 days ]
    C-peptide
  • Dietary assessment [ Time Frame: 10 days ]
    Weighed food log
  • Anthropometry [ Time Frame: 1 day ]
    Weight (kg)
  • Anthropometry [ Time Frame: 1 day ]
    Height (cm)
  • Anthropometry [ Time Frame: 1 day ]
    Hip and waist circumference (cm)
  • Metabolomics by NMR analysis [ Time Frame: 1 day ]
    Lipoprotein concentration (mol/L), lipoprotein composition (mol/L), glycoprotein acetyl concentration (mol/L), ketone bodies concentration (mol/L)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Glucose metabolism [ Time Frame: 1 day ]
    C-peptide
  • Blood cholesterol [ Time Frame: 1 day ]
    Total and fraction cholesterol
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PREDICT 2: Personalized Responses to Dietary Composition Trial 2
Official Title  ICMJE PREDICT 2: Personalized Responses to Dietary Composition Trial 2
Brief Summary

Foods in the human diet can affect the development of diseases over time, such as diabetes or heart disease. This is because the amount and types of foods in the diet eat can affect a person's weight, and because different foods are metabolised (processed) by the body in different ways.

Scientists have also found that the bacteria in the human gut (the gut microbiome) affect their metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect the levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often for too long, there is a greater chance of developing diseases such as diabetes and cardiovascular disease.

The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in the human gut are found in everyone. This might mean that the best diet to prevent disease needs matching to a person's gut microbiome and it might be possible to find personalised foods or diets that will help reduce the chance of developing chronic disease as well as metabolic syndrome.

The study investigators are recruiting volunteers aged 18-65 years to take part in a study that aims to answer the questions above. Participants will be asked to consume standardised meals over 8 days while wearing glucose monitors (Abbott Freestyle Libre) to measure their blood sugar levels. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record their appetite, food, physical activity and sleep using apps and wearable devices. They will be asked to collect a fecal and saliva sample before consuming the standardised meals, and to provide a fasted blood sample at the end of the study period.

Detailed Description

Choice of design: The study is a single arm mechanistic intervention study.

Study population: Participants will be recruited through online and offline advertisements, and through health professionals.

Screening Assessment: Prospective participants will be selected based on the defined inclusion and exclusion criteria by the study management team. Screening will be online and via phone. Prospective participants will be booked in to start their study period and will receive a study kit by post.

Study duration: Each participant will take part in the study for a period of 12 days.

Dietary intervention: The dietary intervention will be carried out for 8 days within the 12 day study period. On day one, participants will be asked to collect biological samples and fit wearable devices (glucose monitor and physical activity tracker). For the next 8 consecutive days, each participant will be instructed to eat 8 standardised meals for breakfast, which must be their first meal of the day. On two of the days the participants will also be asked to eat a standardised lunch. Participants are free to eat whatever they wish at all other times. The standardised meals will be provided to all participants by the study team via post. The foods included as part of these meals will be foods that are commonly consumed and can be made from products sold in US supermarkets. Participants will be reassured that the amount of food will be designed to ensure a stable body weight over the course of the study. Participants will be asked to consume the entire amount of food indicated for the standardised meals and to record any left-over food via a digital app for which training will be provided at the start of the study. For the remaining 2 days post the 8 day dietary intervention period, participants are free to eat and drink whatever they wish. They will be asked to track all meals, snacks and drinks on their digital app. Participants will also be advised not to change their physical activity patterns during the course of the study. The 12th day of the study involves a visit to a medical clinic where participants will provide a fasted blood sample.

Regular contact will be made with the participants via phone, their app and text messages for the period of the intervention to encourage compliance and answer any queries.

Anthropometry: The participant will be instructed to measure their weight, height, waist and hip circumference.

Dietary and Lifestyle: Participants will be asked to complete a baseline questionnaire online, plus record daily dietary, activity, and psychological data (e.g. hunger) using a digital mobile phone app. Lifestyle information (such as sleep and exercise) will be monitored using digital wearable devices. Training in all apps and equipment will be given through written and online instructions and via communications with the study support staff.

Digital devices: Participants will be asked to record daily dietary and activity information using digital apps and lifestyle information will be monitored using digital wearable devices. The continuous glucose monitor (Freestyle Libre, FSL-CGM) provides continuous glucose profiles for up to 14 days. The FSL-CGM will be inserted on the back of the upper arm, one day before participants begin dietary intervention. This will measure subcutaneous interstitial fluid glucose concentrations every 5 minutes. The CGM will be removed at the end of the intervention period (i.e day 12) by the participant. A contact number will be made available to participants for any inquiries or if any problems arise. Data from the CGM will be downloaded, and glucose profiles will be evaluated on the basis of data collected.

Blood samples: The participant will collect postprandial blood on 2 days using finger-prick blood sampling. They will also provide a fasted blood sample after the study period to measure their baseline metabolomic profile.

Digital app: Participants will be asked to download an app designed specifically for this study, which provides diet & activity logging functionality similar to widely used existing apps such as MyFitnessPal.

Participants will be asked to record and monitor the following information via the digital app and wearable devices, on a daily basis:

  • All food and drink they consume, with serving sizes
  • Sleep and physical activity patterns, including exercise
  • Hunger, satiety and appetite ratings
  • Psychological feeling of energy and well-being
  • Prescription and over-the-counter drug consumption

The app will be available in versions for both iOS (for Apple iPhones) and Android (for other smartphones such as Samsung), and will support a wide range of mobile phone models as expected across the participant population. The app will synchronise remotely with backend database servers, over an encrypted and authenticated API, and will support offline operation for when patients wish to record an entry without network coverage. This continuous background synchronization means that it will not be necessary to explicitly download data from the phone at the end of the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Diabetes
  • Heart Diseases
  • Diet Habit
  • Diet Modification
  • Microbial Colonization
  • Healthy
  • Obesity
  • Metabolism
Intervention  ICMJE Other: Dietary Intervention
To carry out an interventional dietary study using standardised meals to predict an individual's metabolic response to certain foods, using their gut microbiome, metabolic profile, and other measurable characteristics such as weight, sleep and exercise.
Study Arms  ICMJE Experimental: Dietary Intervention
8 day dietary intervention using standardized test meals.
Intervention: Other: Dietary Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female
  • 18-65 years of age (19 year age minimum in Alabama and Nebraska)
  • Body mass index (BMI) between 16.5 and 49.9 kg/m2.
  • Living in the continental USA.
  • Able and willing to comply with the study protocol and provide informed consent.

Exclusion Criteria:

  • Refuse or are unable to provide informed consent to participate in the study.
  • Have ongoing, active inflammatory disease or condition e.g. Rheumatoid arthritis, systemic lupus erythematosus, polymyalgia and other connective tissue diseases.
  • Have had cancer in the last two years, excluding skin cancer.
  • Have been diagnosed with Inflammatory Bowel Disease (ulcerative colitis and Crohn's disease) or Celiac disease (gluten allergy), or any other long-term gastrointestinal disorder that would prevent the individual from safely eating normal US food. Irritable Bowel Syndrome is not an exclusion.
  • Have had bariatric or other major gastrointestinal surgery.
  • Have been medically advised that eating high-fat meals over a period of a few days might be dangerous.
  • Currently suffer from severe anemia or jaundice.
  • Have taken any of the following medications in the last three months:

immunosuppressants (including oral steroids) or antiretroviral therapies or antibiotics (excluding topical antibiotics). If diagnosed with non-alcoholic fatty liver disease, use of any steatogenic medications (amiodarone or methotrexate) in the last three months

  • Have an uncontrolled intercurrent illness (e.g. hepatitis c, influenza)
  • Are using proton pump inhibitors ("PPI"s such as omeprazole and pantoprazole), unless they are able to stop two weeks before the start of the study and abstain from use during the study.
  • Have Type I diabetes mellitus or are taking medications for Type II diabetes mellitus.
  • Are diagnosed with Type II diabetes and not on medications, unless they can show they have a fasting glucose level of <216 mg/dL
  • Have non-alcoholic fatty liver disease and are taking insulin
  • Started antidepressant medication within the last 3 months, or are currently suffering from acute clinically diagnosed depression which is not well controlled.
  • Have had a heart attack (myocardial infarction) or stroke in the last 6 months.
  • Are pregnant or breastfeeding, have given birth in the last three months, or are planning to be pregnant in the next 3 months.
  • Diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa)
  • Are vegan, or unwilling to consume foods that are part of the study.
  • Do not have a mobile phone capable of running the Zoe study/results apps, or are unable to use their phone to operate the apps. As a consequence of this exclusion, all participants must be able to read and write in English, as the app is only available in English.
  • Are unable to have continuous access to their smartphone or unable to wear the activity tracker on their arm for the duration of the study, e.g. because their work will not allow it.
  • Have a known allergy to adhesives like that used to affix the continuous glucose monitor.
  • Are unable or unwilling to visit a Quest center to provide fasting blood samples.
  • Do not have access to wifi or unlimited mobile data to allow them to download the app for free and upload data during the study.
  • Do not have a freezer to store study-related foods required for the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sarah Berry, PhD +44 207 848 4088 sarah.e.berry@kcl.ac.uk
Contact: Inbar Linenberg, MSc +447791871699 inbar@joinzoe.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983733
Other Study ID Numbers  ICMJE PREDICT 2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zoe Global Limited
Study Sponsor  ICMJE Zoe Global Limited
Collaborators  ICMJE
  • Massachusetts General Hospital
  • Stanford University
  • King's College London
  • Tufts University
Investigators  ICMJE
Principal Investigator: Tim Spector, Pr. Zoe Global Limited
PRS Account Zoe Global Limited
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP