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Behavioral Intervention

Soda Intake Biomarkers in Healthy Diets

Phase 1
Recruiting
Led By Susi M Votruba
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women and men between the ages of 18-65 years will be recruited for this study
Women and men between the ages of 18-65 years will be recruited for this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8, week 10, week 12
Awards & highlights

Study Summary

This trial is testing if stable isotopes can help assess what people eat. Healthy adults ages 18-65 will stay at the NIH for 13 weeks, eating either a balanced diet or one with different percentages of carbohydrates. There will be various tests throughout to measure things like weight, body composition, and metabolism.

Who is the study for?
Healthy adults aged 18-65 with a BMI ≤35 kg/m² can join this study. They must not be on metabolism-affecting meds, have high fasting blood sugar, or dietary restrictions that prevent them from following the study diet. Pregnant or breastfeeding individuals and those with certain medical conditions or substance abuse issues are excluded.Check my eligibility
What is being tested?
The trial is testing how different diets affect health markers using stable isotopes to track intake. Participants will follow one of three diets varying in soda-derived carbohydrates while staying at an NIH facility for observations including body scans, glucose tests, and metabolic measurements.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include changes in weight, blood sugar levels, and potential discomfort from consuming large amounts of soda depending on the assigned diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8, week 10, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8, week 10, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the blood carbon stable isotope ratio (13C/12C) from baseline to 12 weeks.
Change in the hair carbon stable isotope ratio (13C/12C) from baseline to 12 weeks.
Secondary outcome measures
24h EE and its components from the metabolic chamber.
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.
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Diet with no sodaExperimental Treatment1 Intervention
This group will receive a weight-maintaining diet without soda. All 50% of carbohydrates will originate from sources other than corn and sugar cane.
Group II: Diet with 50% of carb intake from sodaExperimental Treatment1 Intervention
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.
Group III: Diet with 20% of carb intake from sodaExperimental Treatment1 Intervention
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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,346 Previous Clinical Trials
4,314,348 Total Patients Enrolled
4 Trials studying Diet Therapy
270 Patients Enrolled for Diet Therapy
Susi M VotrubaPrincipal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 Previous Clinical Trials
1,140 Total Patients Enrolled
Susanne Votruba, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
3 Previous Clinical Trials
1,282 Total Patients Enrolled
2 Trials studying Diet Therapy
142 Patients Enrolled for Diet Therapy

Media Library

Diet with 20% of carb intake from soda (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04799301 — Phase 1
Diet Therapy Research Study Groups: Diet with 20% of carb intake from soda, Diet with 50% of carb intake from soda, Diet with no soda
Diet Therapy Clinical Trial 2023: Diet with 20% of carb intake from soda Highlights & Side Effects. Trial Name: NCT04799301 — Phase 1
Diet with 20% of carb intake from soda (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04799301 — Phase 1
Diet Therapy Patient Testimony for trial: Trial Name: NCT04799301 — Phase 1

Frequently Asked Questions

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

Are septuagenarians accepted to partake in this experiment?

"This study requires that participants range from 18 to 65 years old. If a patient is younger than the age of consent, there are 50 trials suitable for their condition and if they are over 65 then 376 other studies may be able to accommodate them."

Answered by AI

What is the ultimate goal of this medical experiment?

"The primary outcome to be evaluated over baseline and week 12 of this trial is the alteration in blood carbon stable isotope ratio, measured as 13C/12C. Secondary objectives are Change in urinary sucrose/fructose over time and with varying levels of SSB intake (assessed by repeated measures two-way ANOVA), Change in the carbon stable isotope ratio of alanine from baseline to 12 weeks (measured using a difference of 1.5 (+/-) from baseline and examined through linear mixed models for temporal change), and To determine the effect of dietary changes on the microbiome of the gut, single stool samples will be"

Answered by AI

What is the current participant capacity of this clinical trial?

"Affirmative. According to the clinicaltrials.gov website, this medical experiment is actively recruiting participants; it was first announced on February 23rd 2022 and has been recently modified as of November 5th 2022. Sixty patients must be enrolled from a single hospital or clinic site."

Answered by AI

How deleterious would a diet be that consists of 20% carbohydrates from soda?

"As this is a Phase 1 trial, our team at Power has assigned Diet with 20% of carb intake from soda a score of 1 since there is limited data to support its safety or efficacy."

Answered by AI

Are there any open positions in this trial at present?

"Data on clinicaltrials.gov verifies that this medical trial is still recruiting patients, with the initial posting taking place back in February 23rd of 2022 and a recent update occurring on November 5th of the same year."

Answered by AI

Is it feasible for me to become involved in this clinical investigation?

"This investigation is searching for 60 volunteers aged 18–65 to partake in the dietary therapy. Eligibility requirements include: being a man or woman between those ages, exhibiting good health as attested by medical history and physical tests, and having a body mass index not exceeding 35kg/m(2)."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
Arizona
How old are they?
18 - 65
What site did they apply to?
NIDDK, Phoenix
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

i want to get paid! I have had a fast acting metabolism since childhood. I'm not entirely sure what this trial will teach me but im hoping it will help me find a way to gain and keep a healthy weight.
PatientReceived no prior treatments
~39 spots leftby Jan 2028