PREDICT 2: Personalized Responses to Dietary Composition Trial 2

NCT03983733 | Completed DMC

• 1 other identifier: PREDICT 2
• Study Type: interventional
• Target: 1,139
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Heart Diseases; Diet Habit; Diet Modification; Microbial Colonization; Healthy; Obesity; Metabolism

Keywords

Gut microbiome; Personalised Nutrition; Metabolic health; Postprandial metabolism

Outcome Measures

Primary Outcomes (6)

• Gut microbiome species richness

  Species count in fecal sample

  1 Day

• Lipids

  Measurement of blood lipids

  3 days

• Glucose

  Measurement of blood glucose

  11 days

• Sleep

  Record of sleep pattern using a wearable device (i.e. fitness watch)

  10 days

• Physical activity

  Record of physical activity using a wearable device (i.e. fitness watch)

  10 days

• Hunger and appetite assessment

  Record of hunger and appetite patterns using a digital app

  10 days

Secondary Outcomes (8)

• Glucose metabolism

  3 days

• Dietary assessment

  10 days

• Anthropometry

  1 day

• Anthropometry

  1 day

• Anthropometry

  1 day

Other Outcomes (12)

• Adherence (in sub-cohort)

  12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks

• Hunger (in sub-cohort)

  12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks

• Weight (in sub-cohort)

  12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks

Study Arms (1)

Dietary Intervention

EXPERIMENTAL

Dietary intervention using standardised test meals, on up to 8 days within the study period.

Other: Dietary Intervention

Interventions

Dietary Intervention OTHER

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.

Dietary Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Zoe Global Limited: lead
• Massachusetts General Hospital: collaborator
• Stanford University: collaborator
• King's College London: collaborator
• Tufts University: collaborator

Study Sites (1)

Zoe US Inc.

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Heart Diseases; Feeding Behavior; Communicable Diseases; Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Behavior, Animal; Behavior; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Tim Spector, Pr.

  Zoe Global Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 12, 2019
• Study Start: June 10, 2019
• Primary Completion: March 31, 2020
• Study Completion: December 1, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)