What side effects are associated with this type of intervention?

Common treatments for fatigue that focus on maintaining blood sugar levels include slow digestible carbohydrates like SuperStarch. These treatments are generally well-tolerated, but potential side effects can include gastrointestinal discomfort such as bloating, gas, and diarrhea. Additionally, maintaining stable blood sugar levels can sometimes lead to mild hypoglycemia if not monitored properly. It is important to consult with a healthcare provider to tailor the treatment to individual needs and monitor for any adverse effects.

What prior FDA approvals exist?

The FDA has approved various treatments for fatigue, particularly in conditions like multiple sclerosis and chronic fatigue syndrome. However, specific treatments similar to SuperStarch, which focuses on maintaining blood sugar levels, are less common. Treatments for fatigue often include medications like modafinil and armodafinil, which are used to promote wakefulness. While SuperStarch is being studied for its potential benefits in maintaining blood sugar levels and possibly aiding in fatigue management, there are no direct FDA-approved treatments for fatigue that function primarily as slow digestible carbohydrates.

What other types of research exist?

Promising alternatives to SuperStarch for fatigue patients include hydrothermally modified slow release corn starch, which has been used successfully in treating hypoglycemia. Additionally, glucagon-like peptide-1 (GLP-1) based therapies, such as semaglutide and liraglutide, have shown efficacy in maintaining blood sugar levels and could be considered as novel options.

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Carbohydrate

Carbohydrate Drink for Fatigue

N/A

Waitlist Available

Research Sponsored by University of Western Ontario, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 to 35 year old man or woman

Be between 18 and 65 years old

Must not have

history of gastrointestinal, endocrine, cardiovascular disease or diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial will test SuperStarch, a slow-digesting carbohydrate, in 25 men to see if it helps with mental function, appetite control, and fat loss by keeping blood sugar levels steady.

Who is the study for?

This trial is for healthy men and women aged 18 to 35 who are not participating in other research, do not smoke, are not pregnant, and have no history of gastrointestinal, endocrine, cardiovascular diseases or diabetes. They should also not have any neurological or psychiatric conditions that may affect cognitive function and mustn't have been on a weight loss diet recently.

What is being tested?

The study tests the effects of SuperStarch—a carbohydrate drink—on mental function, appetite control, metabolism, exercise performance and potential fat loss benefits compared to a placebo. The focus is on how it maintains blood sugar levels over time which could influence these factors.

What are the potential side effects?

While specific side effects aren't listed for this trial as it involves a nutritional intervention rather than medication; participants might experience changes in digestion or appetite due to the carbohydrate intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of stomach, hormone, heart diseases, or diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Carbohydrate drinkExperimental Treatment2 Interventions

Ingest 500ml (1g/kg) prior to metabolic measures.

Group II: PlaceboPlacebo Group2 Interventions

Ingest 500ml of placebo prior to metabolic measures.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for fatigue, such as slow digestible carbohydrates like SuperStarch, work by maintaining stable blood sugar levels over extended periods. This steady release of glucose helps prevent energy crashes and sustains energy levels, which is crucial for managing fatigue. By ensuring a consistent energy supply, these treatments can improve cognitive function and exercise performance, addressing one of the core issues in fatigue patients—unstable energy levels.

Comparison of ingesting a food bar containing whey protein and isomalto-oligosaccharides to carbohydrate on performance and recovery from an acute bout of resistance-exercise and sprint conditioning: an open label, randomized, counterbalanced, crossover pilot study.The Effects of an Oral Taurine Dose and Supplementation Period on Endurance Exercise Performance in Humans: A Meta-Analysis.Effect of physical exercise on spontaneous physical activity energy expenditure and energy intake in overweight adults (the EFECT study): a study protocol for a randomized controlled trial.