Soda Intake Biomarkers in Healthy Diets

Overseen By Susanne M Votruba, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Must not be taking: Metabolism drugs

Disqualifiers: Diabetes, Thyroid disorders, Gastrointestinal disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to assess dietary intake using stable isotopes, unique markers that trace food consumption. Researchers are exploring how varying soda levels in a diet affect these markers. Participants will follow a specific diet plan, with variations including 0% (no soda), 20% (20% of carb intake from soda), or 50% (50% of carb intake from soda). Healthy adults without chronic health issues who have maintained a steady weight over the past three months may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking dietary research.

Will I have to stop taking my current medications?

The trial requires that participants have not used medications affecting metabolism and appetite in the last three months. If you are currently taking such medications, you may need to stop them to be eligible for the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that drinking diet soda daily might increase health risks. Some studies suggest it could raise the risk of conditions like metabolic syndrome (a group of health issues that together increase the risk of heart disease, stroke, and type 2 diabetes) and nonalcoholic fatty liver disease. While diet soda is not immediately harmful, concerns exist about its long-term effects.

For diets where half of the carbohydrates come from soda, studies indicate that sugary sodas can lead to weight gain and other health problems. Excessive consumption of sugary soda may increase the risk of liver disease, diabetes, and even some cancers.

These findings highlight potential risks, but not everyone will experience the same effects. It's important to consider this information when deciding to join a trial involving soda consumption. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover how different levels of soda consumption impact health when soda is a major source of carbohydrates. Unlike typical dietary studies that focus on reducing sugar intake, this trial explores the effects of replacing a significant portion of carbohydrates with soda. This unique approach could reveal specific biomarkers that show how soda affects metabolism and overall health. Understanding these biomarkers could lead to new dietary recommendations and insights into the role of sugar-sweetened beverages in our diets.

What evidence suggests that this trial's diets could be effective for assessing dietary intake?

This trial will compare different levels of soda intake as part of a diet. Research has shown that drinking soda, even within a balanced diet, can harm health. For example, studies have found that when 20% of daily carbohydrates come from soda, it can lead to weight gain and a higher risk of diabetes and heart disease. Participants in one arm of this trial will follow a diet with 20% of carbohydrates from soda. Another arm will involve a diet with 50% of carbohydrates from soda, which studies have linked to a greater chance of developing metabolic syndrome (a group of conditions that increase heart disease risk) and nonalcoholic fatty liver disease. Both levels of soda consumption can also lead to increased calorie intake, potentially causing weight gain. These findings suggest that soda, as a major source of daily carbs, could have negative health effects. ^{1 6 7 8 9}

Who Is on the Research Team?

Susanne M Votruba, Ph.D.

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are in good health based on your medical history, physical exam, and lab tests.

Your body mass index (BMI) is less than or equal to 35 kg/m(2) to make sure that your body size doesn't affect the measurements we take.

Healthy, as determined by medical history, physical examination, and laboratory tests

Exclusion Criteria

Fasting plasma glucose greater than or equal to 126 mg/dL

You have been diagnosed with binge eating disorder, anorexia nervosa, or bulimia nervosa.

Evidence of alcohol abuse as defined by greater than or equal to 8-point score on the Alcohol consumption screening AUDIT questionnaire in adults

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Dietary Intervention

Participants will stay in the inpatient unit for 13 weeks, consuming specific diets with varying carbohydrate percentages from soda.

13 weeks

Continuous inpatient stay

Metabolic Assessment

Participants will undergo metabolic assessments including body scans, glucose tolerance tests, and stays in a metabolic chamber.

Throughout 13 weeks

Follow-up

Participants are monitored for changes in stable isotope ratios and other biomarkers after dietary intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diet with 20% of carb intake from soda
• Diet with 50% of carb intake from soda
• Diet with no soda

Trial Overview 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.

How Is the Trial Designed?

Group I: Diet with no soda Experimental Treatment 1 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 soda Experimental Treatment 1 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 soda Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study involving 32 Wistar rats over 14 weeks, a high carbohydrate diet combined with carbonated soda led to increased body weight and abdominal circumference in male rats, indicating potential metabolic dysfunction.

While soda consumption raised total cholesterol and reduced HDL levels in both sexes, female rats on a high carbohydrate diet showed increased glutathione levels, suggesting a complex interaction between diet and metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A high carbohydrate and soda diet influences metabolic variables in Wistar rats. Adedeji, TG., Abosede, CO., Dareowolabi, BO.[2022]

In a study of 2019 participants over an average follow-up of 11 years, regular consumption of sugar-sweetened soda was linked to a higher risk of developing diabetes, with a hazard ratio of 1.15 for each additional soda consumed per day.

While diet soda consumption was initially thought to be a safer alternative, the study found that it may still pose an independent risk for diabetes, particularly among overweight or obese individuals, with a hazard ratio of 1.63 for daily consumers compared to those who rarely consume it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet Soda and Sugar-Sweetened Soda Consumption in Relation to Incident Diabetes in the Northern Manhattan Study. Gardener, H., Moon, YP., Rundek, T., et al.[2022]

A 12-week study involving 25 middle-aged men showed that a high sugar diet (24% of energy from sugar) led to significant increases in body weight, waist circumference, and triglyceride levels, indicating a higher risk for cardiovascular disease (CVD).

In contrast, a low sugar diet (6% of energy from sugar) resulted in significant decreases in body weight, waist circumference, and triglycerides, while improving overall lipid profiles, suggesting that reducing sugar intake is crucial for lowering CVD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of High and Low Sugar Diets on Cardiovascular Disease Risk Factors. Ahmad, A., Isherwood, C., Umpleby, M., et al.[2021]

In a study of 203 adults (128 men and 75 women) over a follow-up period averaging 2.5 years, soda consumption was found to be positively associated with weight gain, indicating that higher soda intake may lead to increased body weight.

The research showed that while total daily energy intake did not correlate with changes in weight or glucose regulation, the energy consumed from soda specifically was linked to weight gain, suggesting that soda may contribute to excess energy consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soda consumption during ad libitum food intake predicts weight change. Bundrick, SC., Thearle, MS., Venti, CA., et al.[2021]

In a study of 15,368 participants over a median follow-up of 23 years, higher consumption of diet soda was linked to an increased risk of end-stage renal disease (ESRD), with those drinking more than 7 glasses per week having an 83% higher risk compared to those consuming less than 1 glass per week.

The association between diet soda and ESRD was particularly significant in individuals who were overweight or obese, suggesting that diet soda consumption may have harmful effects on kidney health in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet Soda Consumption and Risk of Incident End Stage Renal Disease. Rebholz, CM., Grams, ME., Steffen, LM., et al.[2023]

In a study of 2500 participants from the Framingham Offspring Study, higher consumption of sugar-sweetened drinks was linked to increased fasting insulin levels, suggesting a negative impact on insulin resistance.

Fruit juice consumption was associated with lower fasting glucose levels, but did not affect fasting insulin or insulin sensitivity, while diet soda showed no significant relationship with any measures of insulin resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surrogate markers of insulin resistance are associated with consumption of sugar-sweetened drinks and fruit juice in middle and older-aged adults. Yoshida, M., McKeown, NM., Rogers, G., et al.[2023]

Regular soda drinkers, particularly those who are overweight or obese, have significantly lower diet quality compared to diet soda drinkers, indicating that sugar-sweetened sodas negatively impact overall nutrition.

Non-soda drinkers tend to have a higher diet quality than diet soda drinkers, suggesting that eliminating soda consumption can lead to better nutritional outcomes, especially for individuals with normal weight and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between Types of Soda Consumption and Overall Diet Quality: Evidence from National Health and Nutrition Examination Survey (NHANES). Rusmevichientong, P., Mitra, S., McEligot, AJ., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-1-9-2021-3b628

Soda Intake Biomarkers in Healthy Diets Research suggests that high sugar intake, including from soda, is linked to weight gain and increased risk of diabetes and cardiovascular disease. Diets with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2660468/

Diet Soda Intake and Risk of Incident Metabolic Syndrome ... RESULTS. At least daily consumption of diet soda was associated with a 36% greater relative risk of incident metabolic syndrome and a 67% greater relative risk ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01237093?term=diet%20soda&rank=3

Study Details | Developing Biomarkers of Dietary Intake An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2475299125029403

Low-Carbohydrate Diet Patterns That Favor High-Quality ... In this prospective longitudinal study, we found that an LCD pattern that retained high-quality carbohydrates was associated with favorable changes in the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5409661/

Impact of High-Carbohydrate Diet on Metabolic Parameters ... The high sugar diet appeared to stimulate food intake, while complex carbohydrates are likely to inhibit the food intake effect.

6. healthline.com healthline.com/nutrition/symptoms-of-drinking-too-much-diet-soda

8 Potential Side Effects of Consuming Too Much Diet Soda 1. Could disrupt gut health · 2. Erodes tooth enamel · 3. May cause headaches · 4. Could decrease bone density · 5. May increase risk of ...

7. cnn.com cnn.com/2025/10/06/health/diet-sugary-soda-fatty-liver-cancer-wellness

Diet and sugary drinks raise risk of common liver disease ... Drinking diet and sugary beverages may raise the risk of nonalcoholic fatty liver disease by up to 60%, according to new research.

8. mayoclinic.org mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/expert-answers/diet-soda/faq-20057855

Diet soda: How much is too much? It's not known if drinking diet soda every day is harmful. The evidence on diet soda's health effects isn't clear.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3497921/

Soft drinks, aspartame, and the risk of cancer ... Intake of aspartame was directly associated with risk of NHL and multiple myeloma and suggestively associated with leukemia in men, although not in women.