Dietary Consultation for Obesity

(ATM Trial)

Overseen By Aman Pritish Aher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bettina Mittendorfer

Must be taking: Diabetes medications

Must not be taking: Tobacco, Alcohol, Supplements

Disqualifiers: Pregnancy, Kidney disease, Cancer, others

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

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how a specific protein, transcription factor EB, in fat tissue affects metabolism in people with obesity. Researchers will examine differences in fat tissue metabolism among individuals with metabolically abnormal obesity, metabolically normal obesity, and lean individuals. Participants with obesity will receive guidance to lose 10% of their body weight through dietary consultation as part of a weight loss intervention. Suitable candidates for this trial include individuals with obesity who do not use tobacco, consume alcohol in excess, or take certain medications affecting metabolism. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on obesity and metabolism.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you should not be using medications known to affect glucose and lipid metabolism, except for certain diabetes medications in the MAO-Type 2 Diabetes group.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that dietary advice for weight loss is generally safe for most people. Studies have found that lifestyle changes, such as altering eating habits, can help individuals with obesity lose weight. This approach is typically easy to manage, with few serious side effects reported.

Participants in these programs might experience common and mild side effects like hunger, tiredness, or mood changes due to reduced calorie intake. However, these effects are usually manageable and normal as the body adjusts to a new diet.

For those with type 2 diabetes, monitoring blood sugar levels closely is important. Weight loss can affect blood sugar, so diabetes medications might need adjustment to maintain safe and effective treatment.

Overall, dietary advice for weight loss is considered a safe method for managing obesity, especially under the guidance of healthcare professionals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the dietary consultation weight loss intervention because it emphasizes personalized dietary guidance aimed at achieving significant weight loss. Unlike standard treatments for obesity, which often involve medications or surgical interventions, this approach focuses on tailored dietary changes to promote a natural and sustainable weight reduction. By targeting specific dietary habits, participants could see improved outcomes not just in weight loss but also in managing conditions like Type 2 Diabetes and liver fat content, offering a holistic health improvement. This method is innovative because it prioritizes lifestyle modification over more invasive options, potentially reducing the risk of side effects associated with other treatments.

What evidence suggests that this dietary consultation weight loss intervention could be effective for obesity?

Research shows that dietary advice can effectively help people lose weight. In this trial, participants in the experimental arms, including those with type 2 diabetes, metabolically normal obese individuals, and metabolically abnormal obese individuals, will undergo a dietary weight loss intervention to achieve a 10% weight loss over about 6 months. Studies have found that following a structured diet plan, which usually involves consuming between 1000 and 1500 calories a day, can lead to significant weight loss. Participants often lose about 2.5 to 3 kilograms (about 5.5 to 6.6 pounds) in 3 to 6 months. For those with type 2 diabetes, losing weight through these lifestyle changes can also help control blood sugar levels and may slow the progression of diabetes. Overall, these approaches positively impact both weight and overall health. ^{1 6 7 8 9}

Who Is on the Research Team?

Bettina Mittendorfer

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

This trial is for people with obesity-related conditions like fatty liver disease, type 2 diabetes, or those who are generally healthy. Participants should be willing to undergo body scans and biopsies. Those looking to lose weight may receive dietary consultations.

Inclusion Criteria

I do not have any major organ problems or severe diseases.

Not pregnant or breastfeeding

Weight stable and sedentary before enrollment

Exclusion Criteria

Individuals that do not meet all inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging and Biopsy

Participants undergo body composition testing (DEXA scans, MRI, and MRS scans) and an overnight visit with IV infusion, muscle, and fat tissue biopsies

1-2 weeks

2 visits (in-person)

Weight Loss Intervention

Participants with obesity undergo a dietary weight loss intervention to achieve 10% weight loss

6 months

Regular meetings with study team

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including macrophage gene expression analysis

up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Dietary consultation weight loss intervention

Trial Overview The study aims to understand how fat tissue macrophages affect overall metabolic function in obese individuals compared to lean ones. It involves body composition testing, imaging scans, overnight IVs, and tissue biopsies.

How Is the Trial Designed?

Group I: Metabolically normal obese Individuals (obesity with normoglycemia and normal liver fat content) Experimental Treatment 1 Intervention

Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.

Group II: Metabolically abnormal obese Individuals (obesity with normoglycemia and abnormal liver fat content) Experimental Treatment 1 Intervention

Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.

Group III: Individuals with Type 2 Diabetes Mellitus Experimental Treatment 1 Intervention

Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.

Group IV: Lean Individuals Active Control 1 Intervention

No intervention will be administered.

Who Is Running the Clinical Trial?

Bettina Mittendorfer

Lead Sponsor

Trials

3

Recruited

220+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Participants in a weight reduction program valued face-to-face meetings with healthcare providers, which helped them feel supported and understood, contributing to their success in losing weight.

The study highlighted that personalized dietary advice and support from friends or partners are crucial for sustainable weight loss, suggesting that programs should be tailored to individual life situations and include motivational techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary advice on prescription: experiences with a weight reduction programme. Bräutigam-Ewe, M., Lydell, M., Månsson, J., et al.[2018]

In a study involving 53 overweight patients, those following a healthy eating diet lost an average of 6.0 kg over 12 weeks, which was significantly more than the 4.2 kg lost by those on an energy prescription diet.

Both dietary approaches resulted in clinically significant weight loss, but the healthy eating diet proved to be more effective, suggesting the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled clinical trial of two weight reducing diets in a NHS hospital dietetic outpatient clinic: a pilot study. Taylor, F., Irons, L., Finn, P., et al.[2007]

In a study involving 53 overweight patients, those following a healthy eating diet lost an average of 6.0 kg over 12 weeks, which was significantly more than the 4.2 kg lost by those on an energy prescription diet.

Both dietary approaches resulted in clinically significant weight loss, but the healthy eating diet proved to be more effective, suggesting the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled clinical trial of two weight reducing diets in a NHS hospital dietetic outpatient clinic - a pilot study. Taylor, FC., Irons, LJ., Finn, 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]

Obese patients attending dietetic clinics emphasized the importance of support from dietitians for weight management, highlighting that accountability to a professional helped them make lifestyle changes.

Patients reported positive impacts on their lives from dietary treatment, including increased knowledge about healthy eating and physical activity, but also expressed feelings of frustration and being overwhelmed by the necessary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation of obese adults' views of the outcomes of dietary treatment. Jones, N., Furlanetto, DL., Jackson, JA., et al.[2007]

Dietetic intervention for obesity aims to create a negative energy balance and promote healthy eating habits for long-term weight maintenance, tailored to the individual's physiological and psychological needs.

The paper emphasizes the importance of balanced, hypocaloric diets over popular 'magic diets' that lack scientific support, highlighting the need for evidence-based approaches to weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Slimming diets]. Marques-Lopes, I., Russolillo, G., Lopes-Rosado, E.[2020]

There is a lack of consensus guidelines for dietary management of obesity across Europe, leading to inconsistent recommendations among dietitians, as shown by two surveys.

While dietitians often aim for a 5-15% weight loss in their interventions, they do not adequately monitor body composition changes or prevent weight regain, highlighting the need for standardized guidelines in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietetic management of obesity in Europe: gaps in current practice. Vlassopoulos, A., Govers, E., Mulrooney, H., et al.[2021]

Dietitians play a crucial role in managing obesity by evaluating patients' 7-day food records and providing personalized dietary advice based on individual dietary composition and lifestyle factors.

A balanced energy-restricted diet, primarily focusing on reducing fat intake, is recommended, and regular follow-ups with a dietitian are essential for the long-term success of obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The work of the dietician in the outpatient obesity unit]. Raisová, V.[2009]

Dietary counseling can lead to modest weight loss in overweight adults, with a maximum reduction of about 1.9 BMI units (approximately 6%) observed at 12 months compared to usual care.

However, the effectiveness of dietary counseling diminishes over time, with participants regaining weight at a rate of about 0.02 to 0.03 BMI units per month during maintenance phases, highlighting the need for ongoing support and effective strategies to sustain weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis: the effect of dietary counseling for weight loss. Dansinger, ML., Tatsioni, A., Wong, JB., et al.[2022]

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Long-term effectiveness of lifestyle and behavioral weight ... The majority of lifestyle weight-loss interventions in overweight or obese adults with type 2 diabetes resulted in weight loss <5% and did not result in ...

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