Monosaccharide Supplementation for Healthy Adults

Overseen By Emanual Maverakis, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Davis

Must not be taking: Prescription, Over-the-counter, Supplements, others

Disqualifiers: Autoimmune, Cardiovascular, Endocrine, Metabolic, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

44 Participants Needed

Trial Summary

What is the purpose of this trial?

Two randomized double-blind placebo-controlled clinical studies to assess the effects of dietary glycan monomer supplementation on the immune system, especially antibody glycosylation in healthy adults. Immune profiling and glycoproteomics will be performed on serum isolated at these same time points.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or over-the-counter medications, as well as most supplements, to participate in this trial.

What data supports the effectiveness of the treatment Monosaccharide Powder for healthy adults?

Some studies suggest that certain carbohydrates, like oligomalt and sucromalt, which are similar to monosaccharides, can be well-tolerated and may have benefits like improved energy levels and immune modulation. However, direct evidence for the effectiveness of Monosaccharide Powder specifically is not provided in the available research. ^{1 2 3 4 5}

Is monosaccharide supplementation safe for healthy adults?

Research on similar carbohydrate supplements, like oligomalt and cellobiose, shows they are generally safe for healthy adults, though some people may experience mild digestive issues like gas or bloating at higher doses. ^{1 4 6 7 8}

How is the Monosaccharide Powder treatment different from other treatments for healthy adults?

Monosaccharide Powder is unique because it involves supplementing with individual sugar units, which may offer a different metabolic response compared to complex carbohydrates or sugars with a high glycemic index. This approach is novel as it focuses on the potential benefits of monosaccharides, which are simpler forms of carbohydrates, in contrast to other treatments that often use more complex carbohydrate forms. ^{5 7 9 10 11}

Research Team

Emanual Maverakis

Principal Investigator

University of California, Davis

Eligibility Criteria

Healthy adults aged 18-45 with a BMI of 18.5-25 can join this trial. They shouldn't have taken any supplements except basic vitamins, or prescription meds in the last 3 months, and must not be on restrictive diets, consume lots of caffeine or alcohol, or have irregular menstrual cycles.

Inclusion Criteria

I am between 18 and 45 years old.

In general good health

Body Mass Index (BMI) range of 18.5-25

Exclusion Criteria

Individuals with BMI less than 18.5 or greater than 25

I am older than 18 and younger than 45 years old.

I have taken prescription medications in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume dietary supplements or placebo daily for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Long-term Follow-up

Further analysis of immune system effects through various assays

6 months

Treatment Details

Interventions

• Monosaccharide Powder
• Placebo Comparator

Trial Overview The study is testing if taking a monosaccharide powder supplement affects immune system proteins differently than a placebo (a substance with no active drug). Participants will be randomly assigned to one group or the other without knowing which they're getting.

Participant Groups

Group I: Experimental Supplement 3 Experimental Treatment 1 Intervention

20 subjects will consume 50 grams of dietary supplement 3 daily for 4 weeks

Group II: Experimental Supplement 2 Experimental Treatment 1 Intervention

6 subjects will consume 12 grams of dietary supplement 2 daily for 4 weeks

Group III: Experimental Supplement 1 Experimental Treatment 1 Intervention

6 subjects will consume 12 grams of dietary supplement 1 daily for 4 weeks

Group IV: Placebo Comparator 1 Placebo Group 1 Intervention

6 subjects will consume 12 grams of placebo dietary supplement daily for 4 weeks

Group V: Placebo Comparator 2 Placebo Group 1 Intervention

6 subjects will consume 50 grams of placebo dietary supplement daily for 4 weeks

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Findings from Research

In a 16-week clinical trial involving 100 overweight or obese participants, Neoagaro-oligosaccharides (NAOs) significantly reduced visceral fat and body weight compared to a placebo, indicating their effectiveness as an anti-obesity supplement.

The NAOs group also showed an increase in high-density lipoprotein (HDL) cholesterol without any adverse effects on safety biomarkers, suggesting that NAOs can be safely used to support weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-obesity effect of Neoagaro-oligosaccharides with overweight and obese subjects: a 16-week, randomized, double-blind, placebo-controlled clinical trial. Baek, HI., Ha, KC., Park, YK., et al.[2023]

The study demonstrated that different types of α-glucans, specifically dextrins and dextrans with varying degrees of polymerization, significantly affect post-prandial glycemic response, with Dextrin DP 3 causing the highest glucose response.

Using minimally invasive glucose monitors in a decentralized setup allowed for effective real-life assessment of glycemic responses, indicating that this method can be a valuable tool for dietary studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Decentralized Study Setup Enables to Quantify the Effect of Polymerization and Linkage of α-Glucans on Post-Prandial Glucose Response. Delodder, F., Rytz, A., Foltzer, F., et al.[2022]

Nondigestible carbohydrates (NDC) have shown promising immune-modulating effects in both animal studies and limited human clinical trials, suggesting they can enhance mucosal and systemic immunity.

Some NDC may exert immune-modulatory effects independently of the microbiota by binding to specific receptors on immune cells, indicating a direct mechanism of action alongside microbiota-dependent effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune-modulatory effects and potential working mechanisms of orally applied nondigestible carbohydrates. Vos, AP., M'Rabet, L., Stahl, B., et al.[2019]

In a study involving 24 healthy adults, a novel slowly digestible carbohydrate called oligomalt was found to have a statistically significant but clinically limited impact on digestive tolerance compared to maltodextrin, particularly in terms of indigestion and abdominal pain.

Oligomalt was safe to use, with no serious adverse events reported, and its gastrointestinal symptoms improved with continued exposure, suggesting it can be effectively used as a carbohydrate source in healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oligomalt, a New Slowly Digestible Carbohydrate, Is Well Tolerated in Healthy Young Men and Women at Intakes Up to 180 Gram per Day: A Randomized, Double-Blind, Crossover Trial. Johansen, OE., Curti, D., von Eynatten, M., et al.[2023]

In a study involving 44 healthy adults, sucromalt, a low-glycemic index carbohydrate, was found to significantly improve perceptions of mental and physical energy and reduce fatigue compared to dextrose (glucose) after 4-5 hours post-consumption.

The results suggest that sucromalt may help maintain energy levels and delay fatigue, indicating its potential as a beneficial alternative to high-GI carbohydrates for sustained energy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of consumption of sucromalt, a slowly digestible carbohydrate, on mental and physical energy questionnaire responses. Dammann, KW., Bell, M., Kanter, M., et al.[2015]

In a study involving healthy subjects, cellobiose was found to be safe and well-tolerated, with a maximum tolerated dose identified as 20 g for single use and 15 g twice daily for repeated consumption.

Despite some mild gastrointestinal side effects like flatulence and transient diarrhea in sensitive individuals, the overall tolerability rating was high, indicating that cellobiose could be a beneficial low-caloric bulking agent in food products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Dose-Escalation Study Demonstrates the Safety and Tolerability of Cellobiose in Healthy Subjects. Moré, MI., Postrach, E., Bothe, G., et al.[2020]

Nondigestible carbohydrates (NDCs), which include various dietary fibers, have specific tolerable intake levels that vary by type, with recommendations ranging from 3.75 g/d for alginate to 25 g/d for soy fiber, based on a review of 103 clinical trials involving adults without gastrointestinal disease.

Overconsumption of NDCs can lead to gastrointestinal side effects, highlighting the need for clear guidelines on their intake to help bridge the gap between actual and recommended fiber consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal Effects and Tolerance of Nondigestible Carbohydrate Consumption. Mysonhimer, AR., Holscher, HD.[2023]

Lactulose has been shown to provide a generally beneficial response in treating constipation compared to a placebo, although the improvement may be only marginal in some cases.

The review included various patient populations, including geriatric and terminally ill patients, but often did not consider dietary techniques that could also aid in improving bowel movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactulose in the management of constipation: a current review. Kot, TV., Pettit-Young, NA.[2017]

Isomaltulose, a low-glycemic index carbohydrate derived from sucrose, has been shown to improve blood glucose control in people with diabetes and may offer metabolic benefits for the general population.

Clinical trials indicate that isomaltulose not only helps in managing glycemia but also supports fat oxidation, and it has potential benefits for weight-loss maintenance and during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Glycemic Index Prototype Isomaltulose-Update of Clinical Trials. Maresch, CC., Petry, SF., Theis, S., et al.[2018]

Supplementing compressed food with maltooligosaccharides (CFMO) significantly improved heart rate recovery and maintained higher blood glucose levels while reducing post-exercise blood lactate levels in soldiers during military training.

Soy oligopeptides (CFSO) also enhanced recovery by accelerating blood lactate clearance and increasing fluid retention, but did not show significant differences in muscle injury or perceived exertion compared to other diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compressed food with added functional oligopeptides improves performance during military endurance training. Zheng, ZQ., Geng, ZH., Liu, JX., et al.[2019]

In a pilot study with 8 healthy participants, ingestion of hydrothermally processed maize starch (HPMS) resulted in significantly higher blood glucose levels at 90 minutes post-ingestion compared to uncooked maize starch (UCMS) and maize-derived dextrose (DEX).

HPMS also led to a lower rate of carbohydrate oxidation during exercise and a higher rate of lipid oxidation, suggesting it may be a more effective carbohydrate source for maintaining energy during physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the metabolic responses to ingestion of hydrothermally processed high-amylopectin content maize, uncooked maize starch or dextrose in healthy individuals. Bracken, RM., Gray, BJ., Turner, D.[2014]

References

1. England pubmed.ncbi.nlm.nih.gov

Anti-obesity effect of Neoagaro-oligosaccharides with overweight and obese subjects: a 16-week, randomized, double-blind, placebo-controlled clinical trial. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Decentralized Study Setup Enables to Quantify the Effect of Polymerization and Linkage of α-Glucans on Post-Prandial Glucose Response. [2022]

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

Immune-modulatory effects and potential working mechanisms of orally applied nondigestible carbohydrates. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Oligomalt, a New Slowly Digestible Carbohydrate, Is Well Tolerated in Healthy Young Men and Women at Intakes Up to 180 Gram per Day: A Randomized, Double-Blind, Crossover Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effects of consumption of sucromalt, a slowly digestible carbohydrate, on mental and physical energy questionnaire responses. [2015]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Dose-Escalation Study Demonstrates the Safety and Tolerability of Cellobiose in Healthy Subjects. [2020]

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

Gastrointestinal Effects and Tolerance of Nondigestible Carbohydrate Consumption. [2023]

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

Lactulose in the management of constipation: a current review. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Low Glycemic Index Prototype Isomaltulose-Update of Clinical Trials. [2018]

10. China pubmed.ncbi.nlm.nih.gov

Compressed food with added functional oligopeptides improves performance during military endurance training. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Comparison of the metabolic responses to ingestion of hydrothermally processed high-amylopectin content maize, uncooked maize starch or dextrose in healthy individuals. [2014]