Dietary Consultation for Obesity

(ATM Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Bettina Mittendorfer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Bettina Mittendorfer

Must be taking: Diabetes medications

Must not be taking: Tobacco, Alcohol, Supplements

Disqualifiers: Pregnancy, Kidney disease, Cancer, others

No Placebo Group

Trial Summary

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.

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.

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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.

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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.

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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.

I am between 18 and 70 years old.

Not pregnant or breastfeeding

Exclusion Criteria

Individuals that do not meet all inclusion criteria

Trial 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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Missouri School of Medicine Columbia, MO

Who Is Running the Clinical Trial?

Bettina Mittendorfer Lead Sponsor

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

National Institutes of Health (NIH) Collaborator

Washington University School of Medicine Collaborator

References

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

An investigation of obese adults' views of the outcomes of dietary treatment. [2007] Although recommendations about the treatment of obesity have been well documented, there is little research into how obese individuals view the outcomes of dietary treatment. It has been suggested that patient involvement in evaluating treatment outcomes may help target issues to assist with the ongoing improvement of dietetic services. The aim of this qualitative study was to collect patients' views on the dietetic service, the treatment outcomes in terms of lifestyle change and the impact that attending the dietetic service had on their lives in order to improve dietetic treatment, and to assist in the selection of appropriate outcome measurements in the future.

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] Outpatient dietary weight reduction for obesity is unsatisfactory. The objective of this study was to compare the efficacy of an energy prescription diet with usual care (a healthy eating diet) in adult overweight patients referred to a NHS hospital dietetic outpatient clinic, in terms of weight change over 12 weeks.

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] Outpatient dietary weight reduction for obesity is unsatisfactory. The objective of this study was to compare the efficacy of an energy prescription diet with usual care (a healthy eating diet) in adult overweight patients referred to a NHS hospital dietetic outpatient clinic, in terms of weight change over 12 weeks.

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

[Evaluation of the effectiveness of personalized and frequent dietetic counseling in the treatment of obesity]. [2016] To evaluate the effectiveness of a nursing intervention (personal and ongoing dietary counselling) on the treatment of obese patients.

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

Dietetic management of obesity in Europe: gaps in current practice. [2021] Despite substantial attention to dietary interventions on the management of obesity, there are no consensus guidelines for dietetic management of obesity in Europe. Two surveys among European dietitians have demonstrated inconsistencies in the approaches recommended within national obesity treatment guidelines. Only a small number of the guidelines include concrete actionable targets for recommended energy deficit, weight loss and weight-loss maintenance. On the other hand, dietitians frequently use 5-15% weight loss as their intervention outcome. However, they fail to monitor changes in body composition beyond weight status and to successfully monitor and prevent weight regain. Europewide guidelines on the dietary treatment of obesity are an overdue requirement for consistent dietetic practice.

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

Meta-analysis: the effect of dietary counseling for weight loss. [2022] Dietary and lifestyle modification efforts are the primary treatments for people who are obese or overweight. The effect of dietary counseling on long-term weight change is unclear.

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

Dietary advice on prescription: experiences with a weight reduction programme. [2018] To describe overweight persons' experiences with weight reduction and participation in the dietary advice on prescription.

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

[The work of the dietician in the outpatient obesity unit]. [2009] The dietitian plays an important role in the care of obese patients. The dietitian evaluates 7 day food records and according to the individual composition of the diet gives dietary advice to the patient. The energy content and macronutrient and micronutrient composition is only one aspect of dietary counselling. Knowledge of patient's familial and economic status as well as his usual eating pattern, his tastes and capabilities of person who does the shopping and cooking are necessary before the diet can be recommended. The balanced energy-restricted diet is used, predominantly with reduction of the fat intake. Energy expenditure in individual patients is considered when the diet is planned. The regular controls by a dietitian are essential in the long-term treatment of obesity.

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

[Slimming diets]. [2020] Dietetic intervention has the following aims: to achieve a negative energy balance, obtain a healthy weight in the obese person and achieve the installation of healthy eating habits in order to maintain weight loss in the long term. Considering dietetic treatment of obesity as a process that is maintained for long periods of time, dietetic intervention should be carried out depending on the physio-pathological and psycho-social characteristics of the obese person. Besides, dietetic therapy should be balanced, healthy and adapted to the eating preferences of the patient. Over the years, due to need and the quest for rapid weight loss, magic diets have been occasioned, created and invented that have become popular and that lack proven efficacy and scientific rigour. This paper makes reference to a balanced hypocaloric diet and reviews the slimming diets that are best known and most used by the obese and/or overweight population.