The effects of variations in macronutrient composition on biomarkers

UMIN ID: UMIN000055667

Registered date:29/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy young adult males
• Date of first enrollment: 2024/09/29
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The participants alternate between low-carb and low-fat days for six days. The combination of the low-carb and low-fat days results in a nutritionally balanced diet based on the Dietary Reference Intakes.
Participants will be required to eat a nutritionally balanced diet based on the dietary reference intakes for six days.

Outcome(s)

• Primary Outcome: Metabolic flexibility
• Secondary Outcome: 24-hour blood glucose level urinary metabolome physical activity appetite gut microbiota

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 30years-old
• Gender: Male
• Exclude criteria: Individuals taking regular medications that affect metabolism (e.g., diabetes treatments, alpha-blockers, beta-blockers). Individuals with diseases that affect metabolism (e.g., diabetes, thyroid disorders). Individuals diagnosed with or having a history of mental illness. Individuals using implanted medical devices such as pacemakers. Individuals with severe cardiovascular disease. Individuals with cancer. Individuals with oral or dental diseases, or those undergoing oral or dental treatment. Individuals with a history of gastrointestinal surgery (primarily involving the esophagus, stomach, duodenum, small intestine, colon, or liver; appendectomy is allowed). Individuals with gastrointestinal diseases. Individuals with knee or back conditions that interfere with daily life. Individuals with extremely irregular eating habits (e.g., frequent skipping of meals, picky eating, frequent snacking, or noticeable irregularities in meal times). Individuals participating in or planning to participate in other studies involving the consumption of food, medication intake, or the application of cosmetics or medications. Individuals with an exercise habit (those exercising for 60 minutes or more per day, at least four days per week). Individuals engaged in heavy physical labor in daily life or planning to do so during the study period (such as physically demanding work, prolonged walking, or standing activities). Individuals who regularly consume excessive alcohol (more than 60g of pure alcohol per day) or tobacco, and who cannot abstain from smoking or drinking for three days prior to the testing days during the study period. Individuals with claustrophobia or a subjective fear of confined spaces. Individuals with food allergies. Other individuals deemed unsuitable by the principal investigator (Yoshinari Uehara, Fukuoka University) for the safe execution of this study.

Related Information

• Primary Sponsor: Fukuoka University
• Source(s) of Monetary Support: Japan Science and Technology Agency