Health TrialsbyHealthPanel

Diaplex and Glycemic Control

ConditionsInsulin SensitivityHealthy Adult
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorStandard Process Inc.

About this trial

The goal of this 16-week double-blind, placebo-controlled pilot study is to determine whether daily Diaplex supplementation improves insulin sensitivity and glycemic control in adults with elevated blood glucose levels, while generating high-quality preliminary data on metabolic effects, glycemic patterns, and safety to inform future trials

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diaplex

    Dietary supplement

    Standard Process Diaplex product

  • Placebo

    Dietary supplement

    Placebo with no chormium ingredients

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: DiaplexActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in HOMA-IR

To determine whether 16 weeks of intervention with Diaplex improves insulin sensitivity versus placebo.

Time frame
Baseline to 16-weeks

Secondary outcomes

1

CGM (Weeks 15-16)

To characterize end-of-intervention glycemic patterns using CGM.

Time frame
2 weeks
2

Mean glucose

To characterize end-of-intervention glycemic patterns using CGM.

Time frame
2 weeks
3

Time-in-Range (70-180 mg/dL)

To characterize end-of-intervention glycemic patterns using CGM.

Time frame
2 weeks
4

Time Above/Below Range

To characterize end-of-intervention glycemic patterns using CGM.

Time frame
2 weeks

Other outcomes

1

Fasting glucose

To evaluate changes in standard metabolic laboratory markers.

Time frame
baseline to 16-weeks
2

Fasting insulin

To evaluate changes in standard metabolic laboratory markers.

Time frame
baseline to 16-weeks
3

HbA1c

To evaluate changes in standard metabolic laboratory markers.

Time frame
baseline to 16-weeks
4

Lipid profile

To evaluate changes in standard metabolic laboratory markers.

Time frame
baseline to 16-weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Standard Process Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: