Gut Health, LBP, Short Chain Fatty Acids, sCD14
Conditions
Brief summary
This is an ancillary study of NCT06159543, which was a clinical trial that examined the effect of a 12-week 1.5 cups daily mango crossover intervention on cardiometabolic outcomes in individuals with prediabetes, male and female, and 40-60 years of age. The goal of this ancillary study is to test the effect of the mango intervention on gut health markers in individuals with prediabetes. The main questions it aims to answer are: 1. What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of gut permeability as measured by lipopolysaccharide-binding protein (LBP) and soluble CD14 (sCD14)? 2. What is the effect of 1.5 cups per day of fresh mango over 12 weeks on microbiome modulation as estimated by short chain fatty acids (SCFAs)? Secondarily: 1. Is LBP a mediator of the relationship between systemic inflammation \[as determined by C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)\] and SCFAs? 2. Is LBP a mediator of the relationship between insulin resistance \[as determined by HOMA-IR\] and SCFAs? 3. Is sCD14 a mediator of the relationship between systemic inflammation \[as determined by C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)\] and SCFAs? 4. Is sCD14 a mediator of the relationship between insulin resistance \[as determined by HOMA-IR\] and SCFAs? Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in LBP, sCD14, and SCFAs. As noted, this is an ancillary study of NCT06159543. Fasting blood was collected at baseline, and at the end of each phase of NCT06159543. This blood will be used to analyze LBP, sCD14 and SCFAs. Fasting blood and insulin were analyzed in NCT06159543, and will used to calculate HOMA-IR in the ancillary study. C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1) will be analyzed NCT06159543.
Interventions
BEHAVIORALMango
1.5 cups/day of mango for 12 weeks
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Participated in NCT06159543
Exclusion criteria
* Did not participate in NCT06159543
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipopolysaccharide-binding protein (LBP) | From baseline to the end of 8 months | Lipopolysaccharide-binding protein (LBP) will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543. |
| sCD14 | From baseline to the end of 8 months | sCD14 will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543. |
| Short Chain Fatty Acids (SCFAs) | From baseline to the end of 8 months | Short Chain Fatty Acids (SCFAs) will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543. |
Countries
United States
Contacts
CONTACTAmandeep Wright, MPH
CONTACTCeline Heskey, DrPH
PRINCIPAL_INVESTIGATORCeline Heskey, DrPH
Loma Linda University
Outcome results
None listed