M4C Nutraceutical Intervention Human Health Effects Pilot

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorConcordia University Wisconsin

About this trial

This 3 month pilot study will be an unblinded, convenience sampling, nutraceutical intervention trial. Twenty fasted subjects will undergo a baseline health assessment via a questionnaire, baseline clinical chemistries, blood lipids, dexa and impedence testing (to identify bone mineral density and body muscle/fat/water composition), and metabolite/novel biomarker testing through whole capillary blood, saliva, and urine collections. Assessments will be repeated every month (3 times after initial assessment) to cover a 3 month period. All measurements from each visit will be compared with baseline using paired t-tests or Chi square testing depending on variable. Power analyses are not included due to the pilot nature of the study. This pilot study will provide the necessary variability estimates for future trials.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults

Disqualifiers

amputation

blood clotting disorder

metal implants or implanted electrical device(s)

known acute or chronic illness; gastrointestinal, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension

Trial design

Design model

Single group

Treatments tested in this trial

  • M4C

    Dietary supplement

    Nutraceutical designed to enhance novel metabolic pathway activity.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: M4C TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Body composition

Dexa scan for bone mineral density

Time frame
3 months
2

Body composition

Dexa scan for body fat distribution

Time frame
3 months
3

Body composition

Dexa scan for body muscle distribution

Time frame
3 months
4

Hemoglobin A1C

measured glycated hemoglobin via whole capillary blood

Time frame
3 months

Secondary outcomes

1

Saliva Melatonin and Cortisol

Concentrations of melatonin and cortisol in saliva (ng/ml) will be collected before bedtime and at rising. Sample melatonin and cortisol will be measured via High Performance liquid chromatography with mass spectrometry (HPLC MS/MS) as potential markers of stress state. Values will be assessed for conformance to reported reference ranges in the literature. Values outside the reference ranges will be considered positive for unhealthy stress response.

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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