NCT03983733

PREDICT 2: Personalized Responses to Dietary Composition Trial 2

Completed NA Last updated 18 January 2022

What this trial tests

NA trial testing Dietary Intervention in Diabetes in 1,139 participants. Completed in 1 December 2021.

Timeline

10 June 2019

Primary endpoint
31 March 2020

1 December 2021

Quick facts

Lead sponsor	Zoe Global Limited
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	1,139
Start date	10 June 2019
Primary completion	31 March 2020
Estimated completion	1 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Dietary Intervention

Conditions studied

• Diabetes — all drugs for Diabetes →
• Heart Diseases — all drugs for Heart Diseases →
• Diet Habit — all drugs for Diet Habit →
• Diet Modification — all drugs for Diet Modification →

Sponsor

Zoe Global Limited

Who can join

Adults 18 to 70, any sex, with Diabetes or Heart Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut microbiome signatures of vegan, vegetarian and omnivore diets and associated health outcomes across 21,561 individuals.
   Fackelmann G, Manghi P, Carlino N, Heidrich V, et al · · 2025 · cited 71× · PMID 39762435 · DOI 10.1038/s41564-024-01870-z
2. Coffee consumption is associated with intestinal Lawsonibacter asaccharolyticus abundance and prevalence across multiple cohorts.
   Manghi P, Bhosle A, Wang K, Marconi R, et al · · 2024 · cited 47× · PMID 39558133 · DOI 10.1038/s41564-024-01858-9
3. Gut micro-organisms associated with health, nutrition and dietary interventions.
   Asnicar F, Manghi P, Fackelmann G, Baldanzi G, et al · · 2026 · cited 3× · PMID 41372407 · DOI 10.1038/s41586-025-09854-7
4. Associations of continuous glucose monitor derived time in range and glycaemic variability with diet lifestyle and demographics.
   Bermingham KM, Smith HA, Duncan EL, Gonzalez JT, et al · · 2026 · PMID 41896538 · DOI 10.1038/s41467-026-70308-3
5. Glycaemic variability, assessed with continuous glucose monitors, is associated with diet, lifestyle and health in people without diabetes.
   Berry S, Bermingham K, Smith H, Gonzalez J, et al · · 2023 · DOI 10.21203/rs.3.rs-3469475/v1