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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how a dietary supplement made of simple sugars (monosaccharides) affects the immune system, particularly antibody production in healthy adults. Participants will take one of three different supplements, including Monosaccharide Powder, or a placebo for comparison. This trial suits healthy adults not on any medication or supplement regimens and who maintain a balanced diet without extreme habits like excessive caffeine or alcohol consumption. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new supplement.

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.

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

Studies have shown that monosaccharides, or simple sugars, are generally well-tolerated by the body. These sugars naturally occur in many foods and serve as the basic building blocks for more complex carbohydrates.

In this trial, participants will take varying amounts of monosaccharide supplements. Although specific safety data for these exact supplements is not yet available, research suggests that monosaccharides in food are likely safe.

This is a phase 1 trial, focusing primarily on safety. In phase 1, treatments are administered to a small group of people to ensure they do not cause serious side effects. Reaching this phase typically indicates that earlier lab or animal studies demonstrated sufficient safety for human testing.

In summary, monosaccharides are common in the diet, and this trial aims to confirm the safety of these supplements for people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Monosaccharide supplementation is unique because it explores the potential benefits of simple sugars in maintaining or improving health. Unlike standard supplements or dietary interventions, which often focus on complex carbohydrates or specific nutrients, these monosaccharide powders deliver straightforward energy sources that might enhance metabolic processes or gut health. Researchers are particularly excited about this approach because it could lead to quick improvements in energy levels and overall well-being without the need for complex dietary changes. Each experimental supplement has a different composition and dosage, offering insights into the optimal type and amount of monosaccharides that could deliver the most benefits.

What evidence suggests that this trial's treatments could be effective for immune system enhancement?

Research shows that monosaccharide supplements might affect the immune system in various ways. One study found a link between these supplements and improved diet quality, as well as a wider variety of gut bacteria, both crucial for health. A diverse range of gut bacteria can enhance immune function. Monosaccharides also aid in glycosylation, where sugars attach to proteins and fats, a process vital for many body functions, including immune response. Although direct evidence on the specific impact of these supplements on immune health is limited, these findings suggest the need for further research. This trial will evaluate different monosaccharide supplements, with participants receiving either one of the experimental supplements or a placebo comparator. ^{6 7 8 9 10}

Who Is on the Research Team?

Emanual Maverakis

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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

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 have taken prescription medications in the last 3 months.

I am going through or have completed menopause.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10196574/

Dietary Intake of Monosaccharides from Foods is Associated ... Monosaccharide intake was associated with diet quality, gut microbial diversity, microbial metabolism, and gastrointestinal inflammation in healthy adults.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8792817/

Metabolism and Health Impacts of Dietary Sugars - PMC Consumption of excessive amounts of added sugars and their effects on human health has been a major concern in the last several decades.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0308814625002274

Development of a comprehensive food glycomic database ... In the common adult diet, the carbohydrate components are composed of combinations of simple sugars (low DPs) and polysaccharides (high DP).

4. nature.com nature.com/articles/s41581-019-0129-4

Glycosylation in health and disease Glycoconjugates are formed by the addition of sugars to proteins and lipids; 17 monosaccharides commonly found in mammalian glycoconjugates are ...

5. mdpi.com mdpi.com/2072-6643/14/8/1639

The Development of the Davis Food Glycopedia—A Glycan ... This work presents a detailed catalogue of the glycans present in complementary foods commonly consumed by toddlers during weaning and foods commonly consumed ...

6. sciencedirect.com sciencedirect.com/topics/biochemistry-genetics-and-molecular-biology/monosaccharide

Monosaccharide - an overview | ScienceDirect Topics Monosaccharides are defined as simple sugars that are six-carbon compounds with alcohol (OH) groups in various positions and spatial arrangements.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7357269/

Saccharide Characteristics and Their Potential Health ... Sugars and other carbohydrates (CHOs) have many characteristics, ranging from molecular composition to functional, physiological, and biochemical behavior.

8. sciencedirect.com sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/monosaccharide

Monosaccharide - an overview Monosaccharides are identified by their carbonyl functional group (aldehyde or ketone) and by the number of carbon atoms they contain.

9. bio.libretexts.org bio.libretexts.org/Bookshelves/Microbiology/Microbiology_(Boundless)/02%3A_Chemistry/2.05%3A_Organic_Compounds/2.5.01%3A_Carbohydrate_Molecules

2.5.1: Carbohydrate Molecules Glucose, galactose, and fructose are monosaccharide isomers, which means they all have the same chemical formula but differ structurally and ...

10. khanacademy.org khanacademy.org/science/ap-biology/chemistry-of-life/properties-structure-and-function-of-biological-macromolecules/a/carbohydrates

Carbohydrates (article) | Chemistry of life Overview of carbohydrates, including structure and properties of monosaccharides, disaccharides, and polysaccharides.