Soda Intake Biomarkers in Healthy Diets

Overseen By Susi 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

Trial Summary

What is the purpose of this trial?

Background: Diet is one of the most modifiable behaviors affecting health. But diet assessment measures that are based on self-report can be inaccurate. Researchers want better ways to address the role of diet in chronic disease. They want to see if stable isotopes can be used to better assess what people eat. Objective: To see if stable isotopes can help scientists identify things people eat. Eligibility: Healthy adults ages 18 to 65 Design: Participants will be screened with a medical history and physical exam. They will have blood and urine tests. These tests will be repeated during the study. Participants will stay in the inpatient unit of the NIH in Phoenix, Arizona, for 13 weeks. For 7 days, participants will eat a diet prepared by the NIH kitchen. They will get balanced meals that are 50% carbohydrates, 20% protein, and 30% fat. Then participants will be randomly placed on one of 3 diets containing different percentages of carbohydrates from soda. Participants height and weight will be measured. The amount of fat and muscle in their body will be measured by body scans that are similar to x-rays. Participants will have oral glucose tolerance tests. They will consume a sugar drink and then give blood samples over 3 hours. Participants will give hair and stool samples. Participants will complete a diet questionnaire. It assesses their food intake over 24 hours. Participants will complete behavioral questionnaires and computer performance tests. Participants will have fat biopsies taken from their stomach and thigh. Participants will have three 24-hour stays in a metabolic chamber. It is used to measure metabolism.

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.

What data supports the effectiveness of the treatment involving soda intake 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 high soda consumption may negatively impact glucose metabolism and insulin resistance, which are important for maintaining healthy blood sugar levels. ^{1 2 3 4 5}

Is it safe to consume a diet with a significant portion of carbohydrates from soda?

Research suggests that consuming a high amount of soda, whether diet or sugar-sweetened, may be linked to health issues like diabetes, weight gain, and metabolic problems. However, the evidence is not entirely consistent, especially for diet soda, and more studies are needed to fully understand the long-term safety. ^{1 2 4 5 6}

How does the soda intake diet treatment differ from other treatments for dietary health?

This treatment is unique because it specifically examines the impact of varying levels of soda consumption on carbohydrate intake, which is not a standard focus in dietary health studies. It explores how different percentages of carbs from soda affect health, unlike typical dietary guidelines that generally recommend reducing sugar intake without specifying soda as a source. ^{1 3 4 5 7}

Research Team

Susi M Votruba, Ph.D.

Principal Investigator

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

Eligibility Criteria

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.

I am between 18 and 65 years old.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

References

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

Diet Soda Consumption and Risk of Incident End Stage Renal Disease. [2023]

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

Soda consumption during ad libitum food intake predicts weight change. [2021]

3. Japan pubmed.ncbi.nlm.nih.gov

Effects of High and Low Sugar Diets on Cardiovascular Disease Risk Factors. [2021]

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

Diet Soda and Sugar-Sweetened Soda Consumption in Relation to Incident Diabetes in the Northern Manhattan Study. [2022]

5. United States 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. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A high carbohydrate and soda diet influences metabolic variables in Wistar rats. [2022]

7. United States 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). [2022]