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Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects

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ClinicalTrials.gov Identifier: NCT01582282
Recruitment Status : Terminated (due to slow enrollment)
First Posted : April 20, 2012
Results First Posted : November 2, 2012
Last Update Posted : November 15, 2012
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Non-Insulin-dependent Diabetes Mellitus
Interventions Dietary Supplement: placebo
Dietary Supplement: 3.4 g psyllium BID
Dietary Supplement: 6.8g psyllium BID
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Psyllium 3.4g BID 6.8g Psyllium BID Placebo
Hide Arm/Group Description Metamucil, psyllium 3.4g BID (6.8g/day) Metamucil, psyllium 6.8g BID (13.6g/day) Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
Period Title: Overall Study
Started 15 14 8
Completed 13 12 8
Not Completed 2 2 0
Reason Not Completed
Adverse Event             1             1             0
Lost to Follow-up             1             0             0
fasting blood glucose outside Protocol             0             1             0
Arm/Group Title Psyllium 3.4g BID 6.8g Psyllium BID Placebo Total
Hide Arm/Group Description Metamucil, psyllium 3.4g BID (6.8g/day) Metamucil, psyllium 6.8g BID (13.6g/day) Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID Total of all reporting groups
Overall Number of Baseline Participants 15 14 8 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 8 participants 37 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
14
 100.0%
8
 100.0%
37
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 14 participants 8 participants 37 participants
61.8  (9.39) 64.8  (8.42) 56.5  (9.99) 61.8  (9.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 8 participants 37 participants
Female
5
  33.3%
5
  35.7%
2
  25.0%
12
  32.4%
Male
10
  66.7%
9
  64.3%
6
  75.0%
25
  67.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 14 participants 8 participants 37 participants
15 14 8 37
1.Primary Outcome
Title Change From Baseline in Fasting Glucose
Hide Description Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title Psyllium 3.4g BID 6.8g Psyllium BID Placebo
Hide Arm/Group Description:
Metamucil, psyllium 3.4g BID (6.8g/day)
Metamucil, psyllium 6.8g BID (13.6g/day)
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
Overall Number of Participants Analyzed 13 12 8
Mean (Standard Error)
Unit of Measure: mg/dL
-7.73  (8.02) -17.81  (8.81) 22.91  (10.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psyllium 3.4g BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 30.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 6.8g Psyllium BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 40.72
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Fasting HbA1c
Hide Description Change is defined as Post-Baseline minus Baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psyllium 3.4g BID 6.8g Psyllium BID Placebo
Hide Arm/Group Description:
Metamucil, psyllium 3.4g BID (6.8g/day)
Metamucil, psyllium 6.8g BID (13.6g/day)
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
Overall Number of Participants Analyzed 13 12 8
Mean (Standard Error)
Unit of Measure: percentage of total hemoglobin
-0.27  (0.12) -0.39  (0.13) 0.26  (0.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psyllium 3.4g BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 6.8g Psyllium BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.65
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Fasting HDL Cholesterol
Hide Description Change is defined as Post-Baseline minus Baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of Covariance of Cholesterol Measures Intent-to-Treat
Arm/Group Title Psyllium 3.4g BID 6.8g Psyllium BID Placebo
Hide Arm/Group Description:
Metamucil, psyllium 3.4g BID (6.8g/day)
Metamucil, psyllium 6.8g BID (13.6g/day)
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
Overall Number of Participants Analyzed 13 12 8
Mean (Standard Error)
Unit of Measure: mg/dL
-0.90  (1.21) 1.58  (1.27) -0.42  (1.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psyllium 3.4g BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.808
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 6.8g Psyllium BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.0
Estimation Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline in Fasting LDL Cholesterol
Hide Description Change is defined as Post-Baseline minus Baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The LDL cholesterol values for two subjects at week 12 were unreportable.
Arm/Group Title Psyllium 3.4g BID 6.8g Psyllium BID Placebo
Hide Arm/Group Description:
Metamucil, psyllium 3.4g BID (6.8g/day)
Metamucil, psyllium 6.8g BID (13.6g/day)
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
Overall Number of Participants Analyzed 11 12 8
Mean (Standard Error)
Unit of Measure: mg/dL
-11.51  (5.86) -5.84  (5.59) -5.41  (6.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psyllium 3.4g BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.508
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 6.8g Psyllium BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.962
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.43
Estimation Comments [Not Specified]
5.Primary Outcome
Title Total Cholesterol Change From Baseline
Hide Description Change is defined as Post-Baseline minus Baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of Covariance of Cholesterol Measures Intent-to-Treat
Arm/Group Title Psyllium 3.4g BID 6.8g Psyllium BID Placebo
Hide Arm/Group Description:
Metamucil, psyllium 3.4g BID (6.8g/day)
Metamucil, psyllium 6.8g BID (13.6g/day)
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
Overall Number of Participants Analyzed 13 12 8
Mean (Standard Error)
Unit of Measure: mg/dL
-12.96  (5.22) -4.88  (5.43) -5.12  (6.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psyllium 3.4g BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.363
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 6.8g Psyllium BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.978
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -.24
Estimation Comments [Not Specified]
6.Primary Outcome
Title Triglyceride Change From Baseline
Hide Description Change is defined as Post-Baseline minus Baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of Covariance of Cholesterol Measures Intent-to-Treat
Arm/Group Title Psyllium 3.4g BID 6.8g Psyllium BID Placebo
Hide Arm/Group Description:
Metamucil, psyllium 3.4g BID (6.8g/day)
Metamucil, psyllium 6.8g BID (13.6g/day)
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
Overall Number of Participants Analyzed 13 12 8
Mean (Standard Error)
Unit of Measure: mg/dL
-8.95  (16.22) -8.26  (17.03) -1.81  (20.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psyllium 3.4g BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.785
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 6.8g Psyllium BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.811
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.45
Estimation Comments [Not Specified]
Time Frame through 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Psyllium 3.4g BID 6.8g Psyllium BID Placebo
Hide Arm/Group Description Metamucil, psyllium 3.4g BID (6.8g/day) Metamucil, psyllium 6.8g BID (13.6g/day) Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
All-Cause Mortality
Psyllium 3.4g BID 6.8g Psyllium BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Psyllium 3.4g BID 6.8g Psyllium BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/14 (0.00%)      0/8 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Psyllium 3.4g BID 6.8g Psyllium BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/15 (80.00%)      12/14 (85.71%)      7/8 (87.50%)    
Eye disorders       
Cataract * 1  1/15 (6.67%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Gastrointestinal disorders       
Abdominal Discomfort * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Abdominal distension * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Abdominal pain * 1  1/15 (6.67%)  1 1/14 (7.14%)  1 0/8 (0.00%)  0
Abdominal pain * 1  1/15 (6.67%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Abnormal faeces * 1  1/15 (6.67%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Constipation * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 2/8 (25.00%)  2
Diarrhoea * 1  4/15 (26.67%)  4 4/14 (28.57%)  4 1/8 (12.50%)  1
Dyspepsia * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Faecal volume increased * 1  0/15 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1
Flatulence * 1  5/15 (33.33%)  6 5/14 (35.71%)  6 1/8 (12.50%)  1
Frequent bowel movements * 1  1/15 (6.67%)  1 1/14 (7.14%)  1 0/8 (0.00%)  0
Gastrointestinal pain * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Nausea * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Stools abnormal * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
General disorders       
Chest pain * 1  1/15 (6.67%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Malaise * 1  0/15 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1
Infections and infestations       
Influenza * 1  2/15 (13.33%)  2 1/14 (7.14%)  1 0/8 (0.00%)  0
Nasopharyngitis * 1  0/15 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1
Tooth abscess * 1  0/15 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1
Investigations       
Stool analysis abnormal * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Metabolism and nutrition disorders       
Hypoglycaemia * 1  0/15 (0.00%)  0 2/14 (14.29%)  2 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Back pain * 1  1/15 (6.67%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Muscle spasms * 1  1/15 (6.67%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Musculoskeletal pain * 1  0/15 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1
Myalgia * 1  1/15 (6.67%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Neck pain * 1  0/15 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1
Pain in extremity * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Nervous system disorders       
Headache * 1  1/15 (6.67%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Transient ischaemic attack * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Tremor * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Psychiatric disorders       
Nervousness * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritus * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Rash pruritic * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Skin discolouration * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Vascular disorders       
Hot flush * 1  0/15 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Data, calculations, interpretations, opinions, and recommendations are the property of P&GP
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John McRorie, PhD
Organization: Procter and Gamble
Phone: 513-622-1423
EMail: mcrorie.jw@pg.com
Layout table for additonal information
Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT01582282    
Other Study ID Numbers: LX-105
First Submitted: April 18, 2012
First Posted: April 20, 2012
Results First Submitted: October 3, 2012
Results First Posted: November 2, 2012
Last Update Posted: November 15, 2012