Dietary Intervention for Healthy Habits and Diet

Recruiting at 1 trial location

Overseen By Dan Sleeper

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zoe Global Limited

Disqualifiers: Pregnancy, Recent heart attack, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

250000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on understanding how different people react to various foods to create personalized diets. Participants will try specific meals and record their bodies' responses, considering factors like exercise and sleep. The research aims to enhance precision nutrition by providing personalized dietary advice through dietary intervention (also known as nutritional counseling or dietary therapy). Ideal participants already use the ZOE testing program, live in the UK or most of the continental US, and can eat standard US meals. Participants must confirm with their primary care doctor that joining is safe, especially if they have a chronic condition. As an unphased trial, this study offers the chance to contribute to groundbreaking research in personalized nutrition.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to check with your primary care physician to ensure the study is safe for you.

What prior data suggests that this dietary intervention is safe?

Research has shown that changing one's diet is generally safe for most people. For example, one review found that special meal plans were safe and manageable for patients receiving chemotherapy. However, the review also noted that poorly balanced diets could sometimes cause issues like tiredness or a weaker immune system. Another study found mixed results when using dietary advice to combat malnutrition, indicating that success can vary from person to person. Overall, these findings suggest that while dietary changes are usually well-tolerated, customizing them to individual needs is important to avoid negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this dietary intervention because it explores the impact of standardized test meals on post-meal metabolic responses. Unlike traditional dietary treatments that focus on long-term diet changes, this approach measures immediate metabolic effects. This method could offer new insights into how specific foods influence metabolism right after eating, potentially leading to more personalized and effective dietary recommendations.

What evidence suggests that this dietary intervention is effective for healthy habits and diet?

Studies have shown that eating healthy can greatly improve both physical and mental health. Research indicates that learning about nutrition can make it easier for people to change their eating habits and feel motivated to do so. This trial will focus on a dietary intervention using standardized test meals to measure the postprandial metabolic response. Some studies have found that such changes help people follow a healthier diet, increase their knowledge about food, and improve their eating habits. Other findings suggest that certain dietary changes can even help people live longer and lower the risk of diseases like cancer as they age. Overall, understanding and changing one's diet can have significant positive effects on health. ^{3 6 7 8 9}

Who Is on the Research Team?

Tim Spector, PhD

Principal Investigator

Zoe Global Limited

Are You a Good Fit for This Trial?

The trial is for adults who are part of the ZOE testing program, have a BMI of at least 16.5 kg/m2, and live in the continental US (excluding New York) or UK. They must be able to follow the study protocol and give informed consent. Those with chronic conditions should consult their doctor before joining.

Inclusion Criteria

Your body mass index (BMI) is 16.5 or higher.

Under care for chronic medical conditions (including eating disorders, type 1 diabetes, type 2 diabetes), and confirm they have checked with their primary care physician that this study is safe for them (US cohort only)

You are currently participating in the ZOE testing program for commercial purposes.

Exclusion Criteria

Are pregnant

Are unable to read and write in English, as the ZOE app is only available in English

I cannot safely eat standard US meals due to allergies or recent surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Dietary Intervention

Participants undergo a dietary intervention with standardized test meals to measure postprandial metabolic response.

6-14 days

Regular contact via phone, app, and text messages

Free-living Monitoring

Participants track all meals, snacks, and drinks using a digital app, and monitor lifestyle factors such as sleep and physical activity.

Up to 14 days

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention, with optional follow-on study for dietary guidance.

12 months

Monthly reporting

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Intervention

Trial Overview

This study tests how different foods affect individuals by using machine learning models to predict responses to diet. Participants will undergo controlled dietary interventions and record their meals during a free-living period to assess various factors' impact on post-meal responses.

How Is the Trial Designed?

Group I: Dietary Intervention Experimental Treatment 1 Intervention

Dietary intervention using standardized test meals after which the postprandial metabolic response is measured.

Who Is Running the Clinical Trial?

Zoe Global Limited

Lead Sponsor

Trials

12

Recruited

11,450,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+

Published Research Related to This Trial

Dietary changes, such as reducing fat and sodium while increasing fiber and fruit and vegetable intake, are crucial for lowering cardiopulmonary risks, yet less than half of U.S. adults follow these recommendations.

While various nutrition education and counseling methods can help improve dietary habits, most successes are seen in research settings with highly motivated individuals, highlighting the need for more practical, interdisciplinary studies to promote long-term dietary changes in the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance of dietary behavior change. Kumanyika, SK., Van Horn, L., Bowen, D., et al.[2019]

A short-term intensive nutritional counseling program significantly improved glycemic control in 75% of patients with type 2 diabetes, compared to only 31.6% in the conventional treatment group, highlighting the efficacy of structured dietary interventions.

Increased fiber intake was associated with better blood glucose control, suggesting that dietary adjustments, particularly in fiber consumption, play a crucial role in managing hyperglycemia in diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Importance of nutritional counseling and dietary fiber content on glycemic control in type 2 diabetic patients under intensive educational intervention]. Carvalho, FS., Pimazoni Netto, A., Zach, P., et al.[2019]

A study involving 64 obese patients showed that personal and ongoing dietary counseling led to a greater average weight loss (3.9 kg) at 2 months compared to a control group (2.2 kg), indicating some effectiveness of the intervention.

However, the overall efficiency of the dietary counseling intervention was deemed low, as the weight loss differences between the groups were not significant at 4 months, suggesting that the resources used may not justify the modest outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the effectiveness of personalized and frequent dietetic counseling in the treatment of obesity]. Vila Córcoles, A., Llor Vilá, C., Pellejá Pellejá, J., et al.[2016]

Diet significantly influences health, cognitive performance, and psychological well-being, but simply providing information about healthy eating is often not enough to change dietary behaviors.

Successful dietary interventions must combine nutrition education with behavioral psychology strategies, such as self-monitoring and coping skills, to effectively promote and maintain dietary changes across different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to dietary regimens. 2: Components of effective interventions. Brownell, KD., Cohen, LR.[2016]

A pilot intervention using participatory workshops successfully helped refugees in Geneva reduce their fat consumption by an average of 58% per recipe, demonstrating a significant behavioral change.

The workshops led to a nine-fold increase in the use of oil-sparing techniques, suggesting that group-based approaches can be more effective than traditional one-on-one dietary counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive group education for refugees from the Former Yugoslavia to reduce their oil consumption. Kruseman, M., Stoll, BE., Stalder, H.[2019]

Traditional dietary counseling methods often fail because they rely on generalized assumptions about patients' health values and abilities, which may not reflect individual needs.

Enhancing nutrition counseling by focusing on active problem-solving and building self-efficacy can help patients successfully adopt and maintain a heart-healthy diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting dietary change. Crawford, S.[2016]

A study involving 400 adult patients showed that 83% of participants reported making dietary modifications after nutrition counseling, indicating effective communication and understanding of dietary advice.

Patients who received counseling felt better emotionally (57%) and physically (37%), and 64% felt more in control of their health, highlighting the positive impact of nutrition counseling on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients report positive nutrition counseling outcomes. Schiller, MR., Miller, M., Moore, C., et al.[2022]

In a study of 59 patients on continuous ambulatory peritoneal dialysis, dietary advice did not lead to significant changes in energy or protein intake over 4 months, indicating that patients struggled to adjust their diets according to recommendations.

While both groups showed similar adherence to dietary advice, the intervention group had a higher success rate in achieving the lower protein intake goal, suggesting that tailored dietary advice may help some patients meet their nutritional needs, but overall dietary adjustments were limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous ambulatory peritoneal dialysis patients are unable to increase dietary intake to recommended levels. Sutton, D., Higgins, B., Stevens, JM.[2007]

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CR has been shown to prolong life and reduce age-related diseases, including cancer, in experimental models.

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Nutrition Intervention

Nutrition Counseling interventions are used to create priorities, goals, and individualized action plans through a collaborative counselor–client relationship.

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A Systematic Review of Feasibility, Safety, and Efficacy

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Dietary Counselling Interventions in Malnutrition Research

The evidence for the use of dietary counselling interventions in the management of malnutrition is inconsistent. Lack of consistency limits ...

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Dietary Counseling Interventions During Radiation Therapy

Early diagnosis of cancer and more targeted therapies have increased the five-year survival rate for many cancers (1, 2). Radiation therapy ...