Personalised Responses to Dietary Composition Trial

NCT03479866 | Unknown

• 1 other identifier: 236407
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

The foods we eat - our diet - can affect whether we develop diseases during our lives, such as diabetes or heart disease. This is because the amount and types of foods we eat can affect our weight, and because different foods are metabolised (processed) by the body in different ways. Scientists have also found that the bacteria in our guts (the gut microbiome) affects our metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often, there's a greater chance of developing diseases such as diabetes. The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in our guts 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 years or over from the TwinsUK cohort to take part in a study that aims to answer the questions above. The participants will need to come in for a clinical visit where they will give blood, stool, saliva and urine samples. The participants will also be given a standardised breakfast and lunch and fitted with a glucose monitor (Abbott Freestyle Libre-CE marked) to monitor their blood sugar levels. After the visit, the participants will be asked to eat standardised meals at home for breakfast for a further 12 days. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record constantly their appetite, food, physical activity and sleep using apps and wearable devices.

Conditions

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

Keywords

Gut microbiome; Personalised Nutrition; Metabolic health

Outcome Measures

Primary Outcomes (6)

• Gut microbiome profile

  Assessment of participants' gut microbiome

  1-2 days

• Lipids

  Measurement of blood lipids

  1 day to 2 weeks

• Glucose

  Measurement of blood Glucose

  2 weeks

• Sleep

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

  2 weeks

• Physical activity

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

  2 weeks

• Hunger and appetite assessment

  Record of hunger and appetite patterns using a digital app

  2 weeks

Other Outcomes (10)

• Inflammation

  1 day

• Glucose metabolism

  2 weeks

• Metabolomics

  1 day

Study Arms (1)

Dietary intervention

EXPERIMENTAL

2 week dietary intervention using standardized test meals

Other: Dietary intervention

Interventions

Dietary intervention OTHER

To carry out an interventional dietary study using standardised meals to predict for an individual their metabolic response to certain foods using the gut microbiome and their metabolic profile. Responses will include post-prandial appetite, levels of satiety, circulating glucose, insulin, ketone bodies and lipid levels.

Dietary intervention

Eligibility Criteria

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

You may qualify if:

• Participant eligibility includes those aged \>18 years who have a body mass index (BMI) between 20 and 49.9 kg/m2.
• Eligibility within a subgroup of participants undergoing the home-based intervention (n=1,100) will require participants to be 18-65 years of age.
• Eligibility within a further subgroup of participants undergoing cardiometabolic phenotyping (n=50) will require participants to be \>55 years of age.

You may not qualify if:

• Refuse or are unable to give informed consent to participate in the study
• Have ongoing inflammatory disease ie RA, SLE, polymyalgia and other connective tissue diseases.
• Have had cancer in the last three years, excluding skin cancer.
• Have had long term gastrointestinal disorders including inflammatory bowel disease (IBD) or Coeliac disease (gluten allergy), but not including IBS.
• Are taking the following daily medications: immunosuppressants, antibiotics in the last three months.
• Are long-term users of PPIs (such as omeprazole and pantoprazole), unless they are able to stop two weeks before the start of the study and remain off them during the two weeks of the study.
• Have type I diabetes mellitus or are taking medications for type II diabetes mellitus. Those not on medications but having a capillary glucose level of \>12mmol/l based on HemoCue will be excluded. Screening blood results will be shared with their GP after the study.
• Are currently suffering from acute clinically diagnosed depression.
• Have had a heart attack (myocardial infarction) or stroke in the last 6 months.
• Are pregnant
• Are vegan, suffering from an eating disorder or unwilling to take foods that are part of the study.
• Do not have a mobile phone capable of running the digital app, or are unable to use it to operate the app.
• Have an allergy to adhesives which would prevent proper attachment of the continuous glucose monitor.
• Are \<55 years of age
• Are not female

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

King's College London

London, England, SE1 7EH, United Kingdom

RECRUITING

Related Publications (9)

• Bermingham KM, May A, Asnicar F, Capdevila J, Leeming ER, Franks PW, Valdes AM, Wolf J, Hadjigeorgiou G, Delahanty LM, Segata N, Spector TD, Berry SE. Snack quality and snack timing are associated with cardiometabolic blood markers: the ZOE PREDICT study. Eur J Nutr. 2024 Feb;63(1):121-133. doi: 10.1007/s00394-023-03241-6. Epub 2023 Sep 15.

  PMID: 37709944 DERIVED

• Bermingham KM, Stensrud S, Asnicar F, Valdes AM, Franks PW, Wolf J, Hadjigeorgiou G, Davies R, Spector TD, Segata N, Berry SE, Hall WL. Exploring the relationship between social jetlag with gut microbial composition, diet and cardiometabolic health, in the ZOE PREDICT 1 cohort. Eur J Nutr. 2023 Dec;62(8):3135-3147. doi: 10.1007/s00394-023-03204-x. Epub 2023 Aug 2.

  PMID: 37528259 DERIVED

• Louca P, Berry SE, Bermingham K, Franks PW, Wolf J, Spector TD, Valdes AM, Chowienczyk P, Menni C. Postprandial Responses to a Standardised Meal in Hypertension: The Mediatory Role of Visceral Fat Mass. Nutrients. 2022 Oct 26;14(21):4499. doi: 10.3390/nu14214499.

  PMID: 36364763 DERIVED

• Merino J, Linenberg I, Bermingham KM, Ganesh S, Bakker E, Delahanty LM, Chan AT, Capdevila Pujol J, Wolf J, Al Khatib H, Franks PW, Spector TD, Ordovas JM, Berry SE, Valdes AM. Validity of continuous glucose monitoring for categorizing glycemic responses to diet: implications for use in personalized nutrition. Am J Clin Nutr. 2022 Jun 7;115(6):1569-1576. doi: 10.1093/ajcn/nqac026.

  PMID: 35134821 DERIVED

• Tsereteli N, Vallat R, Fernandez-Tajes J, Delahanty LM, Ordovas JM, Drew DA, Valdes AM, Segata N, Chan AT, Wolf J, Berry SE, Walker MP, Spector TD, Franks PW. Impact of insufficient sleep on dysregulated blood glucose control under standardised meal conditions. Diabetologia. 2022 Feb;65(2):356-365. doi: 10.1007/s00125-021-05608-y. Epub 2021 Nov 30.

  PMID: 34845532 DERIVED

• Mazidi M, Valdes AM, Ordovas JM, Hall WL, Pujol JC, Wolf J, Hadjigeorgiou G, Segata N, Sattar N, Koivula R, Spector TD, Franks PW, Berry SE. Meal-induced inflammation: postprandial insights from the Personalised REsponses to DIetary Composition Trial (PREDICT) study in 1000 participants. Am J Clin Nutr. 2021 Sep 1;114(3):1028-1038. doi: 10.1093/ajcn/nqab132.

  PMID: 34100082 DERIVED

• Asnicar F, Leeming ER, Dimidi E, Mazidi M, Franks PW, Al Khatib H, Valdes AM, Davies R, Bakker E, Francis L, Chan A, Gibson R, Hadjigeorgiou G, Wolf J, Spector TD, Segata N, Berry SE. Blue poo: impact of gut transit time on the gut microbiome using a novel marker. Gut. 2021 Sep;70(9):1665-1674. doi: 10.1136/gutjnl-2020-323877. Epub 2021 Mar 15.

  PMID: 33722860 DERIVED

• Menni C, Louca P, Berry SE, Vijay A, Astbury S, Leeming ER, Gibson R, Asnicar F, Piccinno G, Wolf J, Davies R, Mangino M, Segata N, Spector TD, Valdes AM. High intake of vegetables is linked to lower white blood cell profile and the effect is mediated by the gut microbiome. BMC Med. 2021 Feb 11;19(1):37. doi: 10.1186/s12916-021-01913-w.

  PMID: 33568158 DERIVED

• Berry SE, Valdes AM, Drew DA, Asnicar F, Mazidi M, Wolf J, Capdevila J, Hadjigeorgiou G, Davies R, Al Khatib H, Bonnett C, Ganesh S, Bakker E, Hart D, Mangino M, Merino J, Linenberg I, Wyatt P, Ordovas JM, Gardner CD, Delahanty LM, Chan AT, Segata N, Franks PW, Spector TD. Human postprandial responses to food and potential for precision nutrition. Nat Med. 2020 Jun;26(6):964-973. doi: 10.1038/s41591-020-0934-0. Epub 2020 Jun 11.

  PMID: 32528151 DERIVED

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

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Berry, PhD

CONTACT

020 7848 4088; sarah.e.berry@kcl.ac.uk

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: March 14, 2018
• First Posted: March 27, 2018
• Study Start: June 4, 2018
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)