Trial Outcomes & Findings for Effects of Micronutrient (Chromium) Supplementation on Diabetes (NCT NCT01709123)
NCT ID: NCT01709123
Last Updated: 2022-06-30
Results Overview
Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
Results posted on
2022-06-30
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.
placebo: Placebo pill for chromium niacinate
|
Chromium Niacinate
Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period
chromium niacinate: 200ug or 500ug supplementation in pill form
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=22 Participants
Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.
placebo: Placebo pill for chromium niacinate
|
Chromium Niacinate
n=22 Participants
Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period
chromium niacinate: 200ug or 500ug supplementation in pill form
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=22 Participants
|
20 Participants
n=22 Participants
|
40 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=22 Participants
|
2 Participants
n=22 Participants
|
4 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=22 Participants
|
13 Participants
n=22 Participants
|
22 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=22 Participants
|
9 Participants
n=22 Participants
|
22 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=22 Participants
|
6 Participants
n=22 Participants
|
13 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=22 Participants
|
16 Participants
n=22 Participants
|
31 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
22 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
44 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.
placebo: Placebo pill for chromium niacinate
|
Chromium Niacinate
n=22 Participants
Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period
chromium niacinate: 200ug or 500ug supplementation in pill form
|
|---|---|---|
|
Blood Glucose Level
Baseline Figures
|
172.39 mg/dL
Standard Error 20.641
|
212.85 mg/dL
Standard Error 21.153
|
|
Blood Glucose Level
Figures:16 weeks
|
164.47 mg/dL
Standard Error 16.187
|
191.25 mg/dL
Standard Error 21.363
|
PRIMARY outcome
Timeframe: Assessed for 16 weeks with five measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks). 16 weeks reported.Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.
placebo: Placebo pill for chromium niacinate
|
Chromium Niacinate
n=22 Participants
Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period
chromium niacinate: 200ug or 500ug supplementation in pill form
|
|---|---|---|
|
Blood Glucose Levels
Baseline Figures
|
9.5667 mmol/mol
Standard Error 0.4708
|
9.7368 mmol/mol
Standard Error 0.4888
|
|
Blood Glucose Levels
Figures: 16 weeks
|
9.2267 mmol/mol
Standard Error 0.4396
|
9.5606 mmol/mol
Standard Error 0.4839
|
SECONDARY outcome
Timeframe: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.Measuring levels of TG (triglycerides), LDL and HDL-cholesterol in blood of patients in the placebo group and the chromium supplement group.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.
placebo: Placebo pill for chromium niacinate
|
Chromium Niacinate
n=22 Participants
Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period
chromium niacinate: 200ug or 500ug supplementation in pill form
|
|---|---|---|
|
Lipid Levels
Baseline Cholesterol values
|
165.50 mg/dL
Standard Error 10.095
|
160.42 mg/dL
Standard Error 7.1301
|
|
Lipid Levels
Cholesterol values:16 weeks
|
158.87 mg/dL
Standard Error 7.6000
|
164.78 mg/dL
Standard Error 9.1092
|
|
Lipid Levels
Baseline HDL values
|
50.944 mg/dL
Standard Error 2.7871
|
53.842 mg/dL
Standard Error 3.1122
|
|
Lipid Levels
HDL values:16 weeks
|
49.733 mg/dL
Standard Error 2.6806
|
54.889 mg/dL
Standard Error 3.1425
|
|
Lipid Levels
Baseline LDL values
|
96.000 mg/dL
Standard Error 7.7147
|
87.579 mg/dL
Standard Error 5.5442
|
|
Lipid Levels
LDL values:16 weeks
|
93.867 mg/dL
Standard Error 7.2170
|
93.556 mg/dL
Standard Error 6.4409
|
|
Lipid Levels
Baseline triglyceride values
|
92.333 mg/dL
Standard Error 10.538
|
91.105 mg/dL
Standard Error 13.914
|
|
Lipid Levels
Triglyceride values:16 weeks
|
77.200 mg/dL
Standard Error 6.0688
|
81.722 mg/dL
Standard Error 14.557
|
SECONDARY outcome
Timeframe: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.Measuring levels of reactive oxygen species (ROS) in blood of patients in the placebo group and chromium supplement group.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.
placebo: Placebo pill for chromium niacinate
|
Chromium Niacinate
n=22 Participants
Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period
chromium niacinate: 200ug or 500ug supplementation in pill form
|
|---|---|---|
|
Blood Levels of Cytokines/Inflammatory Biomarkers
Baseline ROS values
|
53587.3 mean fluorescent unit
Standard Error 1471.25
|
51877.2 mean fluorescent unit
Standard Error 977.774
|
|
Blood Levels of Cytokines/Inflammatory Biomarkers
ROS values:16 weeks
|
56864.8 mean fluorescent unit
Standard Error 1474.31
|
53577.0 mean fluorescent unit
Standard Error 2970.86
|
SECONDARY outcome
Timeframe: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.Measuring levels of Interleukin-6 (IL-6) in blood of patients in the placebo group and chromium supplement group.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.
placebo: Placebo pill for chromium niacinate
|
Chromium Niacinate
n=22 Participants
Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period
chromium niacinate: 200ug or 500ug supplementation in pill form
|
|---|---|---|
|
Blood Levels of Cytokines/Inflammatory Biomarkers
Baseline Interleukin-6 Values
|
1.6795 ug/mL
Standard Error 0.1801
|
1.7754 ug/mL
Standard Error 0.1848
|
|
Blood Levels of Cytokines/Inflammatory Biomarkers
Interleukin-6 Values: 16 weeks
|
2.0290 ug/mL
Standard Error 0.4057
|
2.0000 ug/mL
Standard Error 0.3527
|
SECONDARY outcome
Timeframe: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.Measuring levels of C reactive protein (CRP) in blood of patients in the placebo group and chromium supplement group.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.
placebo: Placebo pill for chromium niacinate
|
Chromium Niacinate
n=22 Participants
Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period
chromium niacinate: 200ug or 500ug supplementation in pill form
|
|---|---|---|
|
Blood Levels of Cytokines/Inflammatory Biomarkers
Baseline CRP values
|
185.20 ug/mL
Standard Error 9.8926
|
186.48 ug/mL
Standard Error 7.6407
|
|
Blood Levels of Cytokines/Inflammatory Biomarkers
CRP values: 16 weeks
|
182.98 ug/mL
Standard Error 9.5580
|
185.11 ug/mL
Standard Error 8.6807
|
SECONDARY outcome
Timeframe: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.Measuring levels of Leptin in blood of patients in the placebo group and chromium supplement group.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.
placebo: Placebo pill for chromium niacinate
|
Chromium Niacinate
n=22 Participants
Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period
chromium niacinate: 200ug or 500ug supplementation in pill form
|
|---|---|---|
|
Blood Levels of Cytokines/Inflammatory Biomarkers
Baseline Leptin values
|
16.715 ug/mL
Standard Error 4.2746
|
16.263 ug/mL
Standard Error 3.3631
|
|
Blood Levels of Cytokines/Inflammatory Biomarkers
Leptin: 16 weeks
|
15.885 ug/mL
Standard Error 4.1824
|
14.776 ug/mL
Standard Error 3.1102
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chromium Niacinate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sushil K. Jain, PhD
Louisiana State University Health Science Shreveport
Phone: 318.675.6086
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place