CLINICAL TRIAL

North American Diet for Obesity

Recruiting · 18+ · All Sexes · Edmonton, Canada

The Alberta NutrIMM Study - Nutrition and Immunity

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About the trial for Obesity

Eligible Conditions
Diabetes Mellitus, Type 2 · Obesity

Treatment Groups

This trial involves 4 different treatments. North American Diet is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
North American Diet
OTHER
Experimental Group 2
North American Diet
OTHER
Experimental Group 3
North American Diet
OTHER
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Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Men and women 18-65 years old that are lean (BMI < 25 kg/m2) and obese (BMI > 30 kg/m2) will be recruited in the Edmonton area.
Waist circumference (cm) criteria: A waist circumference of 102 cm or more in men, or 88cm in women, is associated with health problems such as type 2 diabetes.
Fasting blood glucose levels: lean-NG and obese-NG will have values less than 5.6 mmol/L, Obese-GI will have levels greater than 5.6 mmol/L, but less than 7 mmol/L; and obese-T2DM will have levels greater than or equal to 7 mmol/L.
HbA1c levels: lean-NG and obese-NG will have levels less than 5.6%; obese-GI will have levels greater than 5.6% but less than 6.5%; obese-T2DM will have levels greater than or equal to 6.5%, but less than 10%.
Blood Pressure criteria: lean-NG and obese-NG as being healthy, a blood pressure criterion of less than 130/85 mmHg will be required (represents systolic pressure/diastolic pressure).
Triglycerides (TGs) and high density lipoprotein cholesterol (HDL-C): Lean-NG and obese-NG subjects will have TG levels less than 1.7 mmol/L, and HDL-C levels greater than 1.03 mmol/L for men and greater than 1.29 mmol/L for women.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 4 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 weeks.
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether North American Diet will improve 1 primary outcome, 4 secondary outcomes, and 2 other outcomes in patients with Obesity. Measurement will happen over the course of 4 weeks.

Change in Dietary Intake between Baseline Values and the control menu.
4 WEEKS
A validated food frequency questionnaire for Canadians (Canadian Diet History Questionnaire II (CDHQII)) will be administered to participants before the start of the study in order to better accurately assess/estimate their habitual diet
4 WEEKS
Assess correlations between clinical outcomes and microbiome to identify interactions and microbiome signatures that predict how diet may impact these indicators in obese, insulin resistant, and diabetic subjects.
4 WEEKS
Assess correlations between clinical outcomes and microbiome configurations to identify mechanistic interactions and microbiome signatures that predict how a typical Canadian diet may impact these indicators in obese, insulin resistant, and diabetic subjects
4 WEEKS
Gut microbiota composition by using DNA Sequencing
4 WEEKS
We will utilize illumina 16S rRNA sequencing and whole metagenomics sequencing to characterize the fecal microbiota (that will be enriched for large bowel bacteria) of our clinical participants pre- and post-diet intervention, to explore if a typical Canadian diet, induces changes in gut microbiota composition and gene content in obese, insulin resistant, and diabetic subjects. These methods will be used as a majority of microbiota are not currently culturable.
4 WEEKS
Change in dietary factors will be assessed using: the change in fatty acid composition of PBMC
4 WEEKS
Total lipids in plasma, Red Blood Cells and PBMCs (Peripheral blood mononuclear cell) membranes will be extracted using Folch ratio 4:1 (chloroform:methanol (2:1): KCl). Fatty acid methyl esters will be measured by automated gas liquid chromatography using a 100m CP-Sil 88 fused capillary column. Total phospholipids and lipid classes in PBMCs membrane will be quantified using thin-layer chromatography and identified using internal standards. Total PC, PE and PS in PBMCs membrane will be quantified using HILIC liquid chromatography-tandem mass spectrometry (LC-MS/MS) using an Agilent 1200 series HPLC system coupled to a 3200 QTRAP mass spectrometer.
4 WEEKS
Glycemia after an oral glucose tolerance test by measuring blood Insulin levels
4 WEEKS
Assess Insulin levels over duration of 3 hour Oral Glucose Tolerance Test collecting blood samples at 0, 30, 60, 90, 120, 150 and 180 minutes. Plasma insulin will be determined using commercially available enzymatic immunoassays (ELISA) to compute the insulin resistance index HOMA.
4 WEEKS
Glycemia after an oral glucose tolerance test by measuring blood Glucose levels
4 WEEKS
Assess Glucose levels over duration of 3 hour Oral Glucose Tolerance Test collecting blood samples at 0, 30, 60, 90, 120, 150 and 180 minutes. Plasma glucose will be measured as per the glucose oxidase method.
4 WEEKS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How serious can obesity be?

With proper nutrition you can lose as much as 5 more pounds a week. If you're overweight, you might lose 15 pounds of fat a week or better

Anonymous Patient Answer

Is north american diet typically used in combination with any other treatments?

North American diet used with exercise is commonly practiced in Turkey. Therefore, the results of our study may contribute to further defining the effect of diet on the success of weight maintenance.

Anonymous Patient Answer

What are the signs of obesity?

Obesity is a relatively new health issue with the advent of mass media campaigns, but is now seen across all age groups. It is now more recognisable in middle-aged men at all levels of education. Although obesity affects many aspects of physical and psychological health including cardiovascular disease, more attention needs to be paid to obese adults who may already have an increased risk of diabetes and cancers.

Anonymous Patient Answer

What causes obesity?

Obesity is defined as an excessive increase in body weight in the context of normal health and energy balance. In contrast to the notion of "overweight" that is most commonly used to describe excessive body fat levels, people with obesity might not possess an excess of body fat per se, but they have a disproportionate amount of body fat relative to their body size. At a population level, excess body fat is one of the major modifiable causes of metabolic comorbidities and mortality. At a personal level, the individual causes of excess body fat can include high-fat diets, physical inactivity, and insufficient sleep.

Anonymous Patient Answer

What are common treatments for obesity?

Some treatment options for obesity are limited in use, but there are few conclusive data to show that any particular weight loss method is superior in reducing long-term health risks. This lack of evidence has led to an acceptance of the current 'treating for obesity in the same way as for the prevention of diabetes' stance. Clearly, more effort is needed to identify the most effective approaches for obesity. We should be cautious in advocating universal treatment guidelines for obesity. There are some key factors that should be taken into account when treating obesity.

Anonymous Patient Answer

What is obesity?

Obesity is a multi-dimensional concept which involves features of weight-related parameters, such as body mass index, blood pressure, and health risks. It also includes a multitude of comorbidities and may cause psychological, emotional, and sleep disturbances, impaired self-image, social alienation and limitation in mobility, and reduced quality of life, and in some rare cases death. Given the vast array of comorbidities it is challenging to diagnose, manage, and monitor obesity; and its consequences in human health, including cancer, diabetes, cardiovascular disease, neurological and other disorders.

Anonymous Patient Answer

Can obesity be cured?

Because neither weight loss nor changes in diet significantly help morbidly obese patients or healthy controls. Furthermore, a small percentage of lean subjects become morbidly obese. Because lifestyle modification can cause significant discomfort and emotional distress, it would be more desirable to prevent obesity and later try to treat it when it is established.

Anonymous Patient Answer

How many people get obesity a year in the United States?

About 6.8 million people in the United States are affected by obesity. Obesity affects 19% of females aged 20 years or over and 40% of those aged ≥45 years. Recent findings shows a positive relationship between obesity and the risk of hypertension, which implies that obesity may be an important risk factor, other than risk factors such as race, that contributes to hypertension. Obesity has a substantial impact on the United States health care system.

Anonymous Patient Answer

What does north american diet usually treat?

North American clients tended to overestimate their weight because the diets do not give any instruction or help. These patients rarely are asked to change their diet. Dietitians and nutritionists should consider the potential difficulty of achieving and maintaining a healthy weight in North American patients. (J Am Diet Assoc 2005; 126:4-7) Dietitians should work with weight loss plan for their patients as we will be better providers of support for their patients.

Anonymous Patient Answer

Does north american diet improve quality of life for those with obesity?

Our group demonstrated that obese patients who follow a healthy diet and exercise program had significant improvement in QOL, physical functioning, and mental health. It's important that the patient be educated about these benefits before making any changes in their diet and exercising program.

Anonymous Patient Answer

Is north american diet safe for people?

A Mediterranean diet is an attractive way to promote optimal nutrition in North American society as well as the North American diet being safe for the health of the population by balancing food intake as well as physical activity. The importance of having an optimal diet and exercise should be a key to prevention of weight gain among North American population.

Anonymous Patient Answer

Have there been other clinical trials involving north american diet?

There are numerous diet studies that were written by American scientists. These studies have shown the most significant results and there is no reason to doubt the findings or the results of these studies. The main problem with these studies is that there are many problems with the studies and the researchers that conduct them\n

Anonymous Patient Answer
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