Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

PREDICT 2: Personalized Responses to Dietary Composition Trial 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03983733
Recruitment Status : Completed
First Posted : June 12, 2019
Last Update Posted : September 28, 2020
Sponsor:
Collaborators:
Massachusetts General Hospital
Stanford University
King's College London
Tufts University
Information provided by (Responsible Party):
Zoe Global Limited

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 18-70 years to take part in a study that aims to answer the questions above. Participants will be asked to consume standardised meals on up to 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.


Condition or disease Intervention/treatment Phase
Diabetes Heart Diseases Diet Habit Diet Modification Microbial Colonization Healthy Obesity Metabolism Other: Dietary Intervention Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1139 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: PREDICT 2: Personalized Responses to Dietary Composition Trial 2
Actual Study Start Date : June 10, 2019
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : June 19, 2020

Arm Intervention/treatment
Experimental: Dietary Intervention
Dietary intervention using standardised test meals, on up to 8 days within the study period.
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.




Primary Outcome Measures :
  1. Gut microbiome species richness [ Time Frame: 1 Day ]
    Species count in fecal sample

  2. Lipids [ Time Frame: 3 days ]
    Measurement of blood lipids

  3. Glucose [ Time Frame: 11 days ]
    Measurement of blood glucose

  4. Sleep [ Time Frame: 10 days ]
    Record of sleep pattern using a wearable device (i.e. fitness watch)

  5. Physical activity [ Time Frame: 10 days ]
    Record of physical activity using a wearable device (i.e. fitness watch)

  6. Hunger and appetite assessment [ Time Frame: 10 days ]
    Record of hunger and appetite patterns using a digital app


Secondary Outcome Measures :
  1. Glucose metabolism [ Time Frame: 3 days ]
    C-peptide

  2. Dietary assessment [ Time Frame: 10 days ]
    Weighed food log

  3. Anthropometry [ Time Frame: 1 day ]
    Weight (kg)

  4. Anthropometry [ Time Frame: 1 day ]
    Height (cm)

  5. Anthropometry [ Time Frame: 1 day ]
    Hip and waist circumference (cm)

  6. 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)

  7. Dietary assessment [ Time Frame: 1 month ]
    Diet history and portion size questionnaire about the preceding month, using the Diet History Questionnaire 3 from National Cancer Institute.

  8. Covid-19 symptom assessment [ Time Frame: 6 months ]
    Self-reported demographic and physical health symptoms, or lack thereof, reported on a daily basis.


Other Outcome Measures:
  1. Adherence (in sub-cohort) [ Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks) ]
    Self-reported in-app question on daily frequency of adherence (categorical)

  2. Hunger (in sub-cohort) [ Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks) ]
    Self-reported in-app question on hunger levels (categorical)

  3. Weight (in sub-cohort) [ Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks) ]
    Self-reported in-app question on weight (lbs)

  4. Bristol Stool Category (in sub-cohort) [ Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks) ]
    Self-reported in-app Bristol Stool chart questoin (categorical)

  5. Bowel Frequency (in sub-cohort) [ Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks) ]
    Self-reported in-app question on bowel frequency

  6. Energy (in sub-cohort) [ Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks) ]
    Self-reported in-app question on energy levels (categorical)

  7. Alertness (in sub-cohort) [ Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks) ]
    Self-reported in-app question on alertness (categorical)

  8. Stress (in sub-cohort) [ Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks) ]
    Self-reported in-app question on stress (categorical)

  9. Mood (in sub-cohort) [ Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks) ]
    Self-reported in-app question on mood (categorical)

  10. Activity (in sub-cohort) [ Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks) ]
    Self-reported in-app question on daily frequency of activity (categorical)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female
  • 18-70 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) or insulin in the last 3 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 1 diabetes.
  • Have type 2 diabetes and are taking insulin or sulfonyurea medications (such as Diamicron (Gliclazide), Diamicron MR (Gliclazide), Amaryl (Glimepiride), Daonil (Gilbenclamide or Glyburide), Gibenese (Glipizide), Minodiab (Glipizide), Tolbutamide (Tolbutamide)). For clarity, people with type 2 diabetes can participate if they take metformin or gliptins.
  • Have type 2 diabetes and a fasting glucose level of >216mg/dL. These individuals wil be excluded whether or not they are on medication.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983733


Locations
Layout table for location information
United States, Massachusetts
Zoe US Inc.
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Zoe Global Limited
Massachusetts General Hospital
Stanford University
King's College London
Tufts University
Investigators
Layout table for investigator information
Principal Investigator: Tim Spector, Pr. Zoe Global Limited
Layout table for additonal information
Responsible Party: Zoe Global Limited
ClinicalTrials.gov Identifier: NCT03983733    
Other Study ID Numbers: PREDICT 2
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zoe Global Limited:
Gut microbiome
Personalised Nutrition
Metabolic health
Postprandial metabolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infection
Heart Diseases
Cardiovascular Diseases