Does eating mandarin oranges impact cardiometabolic risk factors and omics biomarkers in a general population intervention trial?

Effect of mandarin orange consumption on omics biomarkers and cardiometabolic phenotypes: A Randomized clinical trial in the general population (MANSomics)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14236593

Enrollment

Registered

2024-09-25

Start date

2024-11-15

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of cardiovascular and metabolic diseases in subjects from the general population Not Applicable

Interventions

Randomized controlled clinical trial with two parallel groups including 70 participants in total. Participants will be randomly assigned 1:1 into two groups using a software program. 1. Intervention g

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Volunteers recruited from the general population 2. Aged 18 to 55 years old 2. Body mass index (BMI) between 23 and 32 kg/m²

Exclusion criteria

Exclusion criteria: 1. Do not meet the inclusion criteria. 2. People allergic or intolerant to the consumption of oranges. 3. Pregnant women or breastfeeding period 4. Alcoholism or drug addiction 5. Individuals presenting the following current situations: infectious diseases, renal diseases, liver diseases, cancer, obesity, type 2 diabetes, or other pathologies that may bias the study.

Design outcomes

Primary

Measure	Time frame
Changes in multi-omics biomarkers (gene-expression, DNA-methylation, and plasma metabolites) from baseline to 15 days following a daily intervention with 1 kg of mandarin oranges in comparison with the control group. Gene-expression will be measured with a whole transcriptomics human array at baseline and after 15 days. DNA-methyation will be measured by a genome-wide methylation human array at baseline and after 15 days. Metabolomics will be measured in plasma by Nuclear Magnetic Resonance at baseline and after 15 days.	—

Measure

Time frame

Changes in multi-omics biomarkers (gene-expression, DNA-methylation, and plasma metabolites) from baseline to 15 days following a daily intervention with 1 kg of mandarin oranges in comparison with the control group. Gene-expression will be measured with a whole transcriptomics human array at baseline and after 15 days. DNA-methyation will be measured by a genome-wide methylation human array at baseline and after 15 days. Metabolomics will be measured in plasma by Nuclear Magnetic Resonance at baseline and after 15 days.

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Secondary

Measure	Time frame
1. Biochemical analysis with hematocrit, lipid profile, blood glucose, renal and hepatic function at baseline and after 15 days. 2. Analysis of parameters related to oxidative stress at baseline and after 15 days. 3. Measurement of blood pressure at the baseline visit and after the intervention at baseline and after 15 days. 4. Weight, height, waist circumference, and body composition through baseline bioimpedance at baseline and after 15 days. 5. Food intake and adherence to the Mediterranean Diet using the food consumption frequency questionnaire and the 14-point adherence questionnaire at baseline and after 15 days. 6. Physical activity measured through the use of accelerometers at baseline and after 15 days. 7. Characteristics of sleep measured using the Epworth Sleepiness Scale and chronotype assessed with the Morningness-Eveningness Questionnaire by Horne and Östberg at baseline and after 15 days.	—

Measure

Time frame

1. Biochemical analysis with hematocrit, lipid profile, blood glucose, renal and hepatic function at baseline and after 15 days. 2. Analysis of parameters related to oxidative stress at baseline and after 15 days. 3. Measurement of blood pressure at the baseline visit and after the intervention at baseline and after 15 days. 4. Weight, height, waist circumference, and body composition through baseline bioimpedance at baseline and after 15 days. 5. Food intake and adherence to the Mediterranean Diet using the food consumption frequency questionnaire and the 14-point adherence questionnaire at baseline and after 15 days. 6. Physical activity measured through the use of accelerometers at baseline and after 15 days. 7. Characteristics of sleep measured using the Epworth Sleepiness Scale and chronotype assessed with the Morningness-Eveningness Questionnaire by Horne and Östberg at baseline and after 15 days.

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Countries

Spain

Contacts

Public ContactEva M Asensio Marquez

eva.m.asensio@uv.es+34 (0)963864417

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026