PREDICT 2: Personalized Responses to Dietary Composition Trial 2

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

Interventions

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.

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• Stanford University

  collaborator OTHER

• King's College London

  collaborator OTHER

• Tufts University

  collaborator OTHER

• Zoe Global Limited

  lead OTHER

Principal Investigators

• Tim Spector, Pr. · Zoe Global Limited

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-06-10

Primary Completion

2020-03-31

Completion

2021-12-01

Countries

• United States

Study Locations