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

Trial Summary

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.

What data supports the effectiveness of the treatment Dietary consultation weight loss intervention for obesity?

Research suggests that personalized and frequent dietary counseling can be effective in treating obesity, as it involves ongoing support and tailored advice to help individuals make lifestyle changes. However, there is a lack of consistent guidelines and monitoring practices, which can affect the overall success of these interventions. ^{1 2 3 4 5}

Is dietary consultation for obesity safe for humans?

The research does not provide specific safety data for dietary consultation for obesity, but dietary and lifestyle changes are generally considered safe for most people when guided by professionals. ^{2 3 5 6 7}

How is the dietary consultation weight loss intervention different from other obesity treatments?

The dietary consultation weight loss intervention is unique because it involves personalized dietary advice based on individual eating habits, preferences, and lifestyle, rather than a one-size-fits-all approach. It emphasizes long-term healthy eating habits and regular follow-ups with a dietitian to ensure sustainable weight loss and prevent weight regain. ^{2 5 7 8 9}

What is the purpose of this trial?

The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals. Both groups will have: * screening visit * imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \[MRI\] and magnetic resonance spectroscopy \[MRS\] scans) * Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies Participants with obesity will complete meetings with study team members for a weight loss intervention to achieve a 10% body weight loss.

Research Team

Bettina Mittendorfer

Principal Investigator

University of Missouri-Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

An investigation of obese adults' views of the outcomes of dietary treatment. [2007]

2. England pubmed.ncbi.nlm.nih.gov

Controlled clinical trial of two weight reducing diets in a NHS hospital dietetic outpatient clinic: a pilot study. [2007]

3. England pubmed.ncbi.nlm.nih.gov

Controlled clinical trial of two weight reducing diets in a NHS hospital dietetic outpatient clinic - a pilot study. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of the effectiveness of personalized and frequent dietetic counseling in the treatment of obesity]. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Dietetic management of obesity in Europe: gaps in current practice. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis: the effect of dietary counseling for weight loss. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Dietary advice on prescription: experiences with a weight reduction programme. [2018]

8. Czech Republic pubmed.ncbi.nlm.nih.gov

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

9. Spain pubmed.ncbi.nlm.nih.gov

[Slimming diets]. [2020]