Diet with 20% of carb intake from soda for Diet Therapy

Phase-Based Estimates
1
Effectiveness
1
Safety
NIDDK, Phoenix, Phoenix, AZ
+1 More
Diet with 20% of carb intake from soda - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Diet Therapy

Study Summary

Developing Biomarkers of Dietary Intake: Dose Dependent Measurement of Sugar Intake

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Eligible Conditions

  • Diet Therapy
  • Healthy Subjects (HS)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Diet with 20% of carb intake from soda will improve 2 primary outcomes and 4 secondary outcomes in patients with Diet Therapy. Measurement will happen over the course of Baseline, every two weeks through Week 12.

Week 12
24h EE and its components from the metabolic chamber.
Baseline, Week 12
Change in the hair carbon stable isotope ratio (13C/12C) from baseline to 12 weeks.
To determine the effect of dietary changes on the microbiome of the gut, single stool samples will be collected upon admission and completion.
Week 12
Change in the blood carbon stable isotope ratio (13C/12C) from baseline to 12 weeks.
Week 12
Change in the carbon stable isotope ratio of alanine from baseline to 12 weeks.
Change in urinary sucrose/fructose over time and with varying levels of SSB intake.

Trial Safety

Trial Design

3 Treatment Groups

No Control Group
Diet with no soda

This trial requires 60 total participants across 3 different treatment groups

This trial involves 3 different treatments. Diet With 20% Of Carb Intake From Soda is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Diet with no soda
Behavioral
This group will receive a weight-maintaining diet without soda. All 50% of carbohydrates will originate from sources other than corn and sugar cane.
Diet with 20% of carb intake from soda
Behavioral
This group will receive a weight-maintaining diet with 20% of carbohydrates provided as soda. The carbohydrates from sources other than corn and sugar cane will be reduced accordingly to meet the total carbohydrate supply.
Diet with 50% of carb intake from soda
Behavioral
This group will receive a weight-maintaining diet with 50% of carbohydrates provided as soda. The carbohydrates from sources other than corn and sugar cane will be reduced accordingly to meet the total carbohydrate supply.

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 8, week 10, week 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, week 8, week 10, week 12 for reporting.

Closest Location

NIDDK, Phoenix - Phoenix, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Body mass index less than or equal to 35 kg/m(2) to minimize the impact of body size on isotope measurements.
You are between the ages of 18-65 years. show original
Healthy, as determined by medical history, physical examination, and laboratory tests.

Patient Q&A Section

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

What causes diet therapy?

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Diet therapy for pediatric obesity is safe, has a high rate of weight loss, and could have a positive impact on metabolic diseases and obesity-associated complications.

Unverified Answer

What are common treatments for diet therapy?

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There is a large gap in the use of diet therapy, which is not necessarily adequately supported by medical evidence. This lack of evidence is due to the multitude of therapies available for diet therapy, lack of consistency regarding what constitutes a treatment, and the unproven theory behind most treatments. There are many treatment options available that have not been substantiated by independent research, so the need for more well-designed clinical research of diet therapy is even more urgent.

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Can diet therapy be cured?

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Very few studies have investigated the potential for dietary intervention to have a long-term therapeutic effect on human disease. Recent findings we demonstrate that diet therapy is a simple and effective intervention for the treatment of some gastrointestinal complaints. Recent findings shows that diet therapy alone or in combination with other therapies is effective in treating gastrointestinal complaints. Recent findings confirm the importance of diet therapy in the management of gastrointestinal complaints and are the first to show some evidence of a long term (10-week) treatment effect of diet therapy. Further investigation is needed of the potential for dietary therapy to be used as a treatment in other disorders in human medicine.

Unverified Answer

What is diet therapy?

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Diet therapy should include dietitians trained in nutritional assessment and counseling. A diet that is tailored to the needs of each patient is the best approach to promote and maintain nutritional and functional status.

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How many people get diet therapy a year in the United States?

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About 1 million people receive diet therapy each year. This adds $2 billion to the annual total cost of behavioral treatment for obesity. Since only a minority of these patients receive behavioral counseling, the amount of money allocated for diet therapy is likely to be too low given the number of patients needing treatment. A broader emphasis on diet therapy treatment will likely to yield important decreases in health costs and improvements in patient satisfaction and quality of care.

Unverified Answer

What are the signs of diet therapy?

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It is hard to identify or classify the exact set of factors that may contribute to the development of diabetes. However, when the signs and symptoms present a danger to the patient, it is helpful to consult a health care provider.

Unverified Answer

How serious can diet therapy be?

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Diet therapy can lead to significant improvements in multiple aspects of nutritional status; however, more than half of the patients fail to see the desired clinical benefits. Most patients are more satisfied with diet therapy when it results in significant clinical gains in their nutrition. Many of the patients report that their weight, mood, and social situations improve significantly with diet therapy. To maximize the benefits of diet therapy a comprehensive assessment of the nutritional status with regard to general health and nutritional needs must be performed.

Unverified Answer

Is diet with 20% of carb intake from soda safe for people?

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These data do not support concerns that a combination of 20% of the total day calorie intake from soda with other diet components (i.e., a healthy balanced diet) would cause a significant decrease in HDL-C and other cardiometabolic risks.

Unverified Answer

What does diet with 20% of carb intake from soda usually treat?

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Dietary treatment of hypervitaminosis D with a 20% of carb intake from soda seems to be very well tolerated but does not treat hypervitaminosis D if compared to a control diet.

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Have there been other clinical trials involving diet with 20% of carb intake from soda?

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There have been other clinical trials examining the effects of diet and weight loss. However, none specifically involved 20% of the carb intake from soda. There is a need for additional trials on this subject.

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What are the common side effects of diet with 20% of carb intake from soda?

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The combination of low-carb diets with 20% of the total daily caloric intake of the diet from soda is safe and effective in the treatment of weight and body composition loss for patients with various diseases.

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Does diet with 20% of carb intake from soda improve quality of life for those with diet therapy?

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Diet therapy with 20% of carb intake from soda improved quality of life for those with diet therapy, an average weight reduction of 1.4 kg at week 24.

Unverified Answer
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