Trial · NCT01950039

Metabolic Effects of Betaine Supplementation

NCT01950039, Phase 2, Completed, Joslin Diabetes Center; results first posted 2021-04-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Metabolic Effects of Betaine Supplementation. Trials, record NCT01950039. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01950039

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Metabolic Effects of Betaine Supplementation
NCT number: NCT01950039
Status: Completed
Phases: Phase 2
Enrollment: 28 participants, actual
Lead sponsor: Joslin Diabetes Center
Conditions: Obesity, Dysglycemia
Interventions: Betaine, Placebo
First posted: 2013-09-25
Last updated: 2021-04-20
Results first posted: 2021-04-20

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.	baseline and 12 weeks	Glucose levels were analyzed in the fasting state and two hours after glucose load, comparing baseline to 12 weeks.
Primary	Change in Glucose AUC at 12 Weeks From Baseline (Glucose Tolerance)	baseline and 12 weeks	Glucose tolerance was assessed by oral glucose tolerance, assessed using the change from baseline for fasting and 2 hour glucose, and change in Glucose AUC at 12 weeks from baseline was measured.
Primary	Hepatic Fat, Change From Baseline	baseline and 12 weeks	Intrahepatic triglyceride levels were assessed by magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (Siemens 3T TIM Skyra, software version VD13; Siemens, Erlangen, Germany).
Primary	Endothelial Function	baseline and 12 weeks	Brachial artery reactivity to flow and nitroglycerin stimuli, assessed as percent change from baseline
Primary	Insulin Sensitivity	Baseline and 12 weeks	Euglycemic hyperinsulinemic clamp at baseline and at end of study (12 weeks) for assessment of: 1. glucose disposal (M) at low (25 mU/m2/min) and high (180 mU/m2/min) insulin infusion rates, reported as raw data 2. measurement of endogenous glucose production at basal and low insulin infusion (25 mU/m2/min), reported as change from measures at baseline of individual study days

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.	baseline and 12 weeks		mg/dl	MEAN
PRIMARY	Change in Glucose AUC at 12 Weeks From Baseline (Glucose Tolerance)	baseline and 12 weeks		mg*min/dL	MEAN
PRIMARY	Hepatic Fat, Change From Baseline	baseline and 12 weeks		percent change in hepatic triglyceride	MEAN
PRIMARY	Endothelial Function	baseline and 12 weeks	One participant in the placebo group was not able to complete nitroglycerine-mediated dilation assessment.	percent change from baseline	MEAN
PRIMARY	Insulin Sensitivity	Baseline and 12 weeks		umol/kg/min	MEAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.	Betaine	fasting glucose	-5	95% Confidence Interval -12 to 1	mg/dl
Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.	Placebo	fasting glucose	3	95% Confidence Interval -4 to 9	mg/dl
Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.	Betaine	2-hour glucose	7	95% Confidence Interval -10 to 25	mg/dl
Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.	Placebo	2-hour glucose	-4	95% Confidence Interval -22 to 13	mg/dl
Change in Glucose AUC at 12 Weeks From Baseline (Glucose Tolerance)	Betaine		340	95% Confidence Interval -993 to 1672	mg*min/dL
Change in Glucose AUC at 12 Weeks From Baseline (Glucose Tolerance)	Placebo		-413	95% Confidence Interval -1749 to 923	mg*min/dL
Hepatic Fat, Change From Baseline	Betaine		-0.01	Standard Error 0.02	percent change in hepatic triglyceride
Hepatic Fat, Change From Baseline	Placebo		-0.03	Standard Error 0.02	percent change in hepatic triglyceride
Endothelial Function	Betaine	Percent change in flow-mediated dilation	-0.5	95% Confidence Interval -3.3 to 2.3	percent change from baseline
Endothelial Function	Placebo	Percent change in flow-mediated dilation	-1.9	95% Confidence Interval -4.7 to 1.0	percent change from baseline

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Betaine	15
Overall Study	STARTED	Placebo	13
Overall Study	Study Drug Initiated	Betaine	14
Overall Study	Study Drug Initiated	Placebo	13
Overall Study	Completed Clamp	Betaine	13
Overall Study	Completed Clamp	Placebo	12
Overall Study	Completed MRI	Betaine	13
Overall Study	Completed MRI	Placebo	12
Overall Study	Completed Endothelial Evaluation	Betaine	14
Overall Study	Completed Endothelial Evaluation	Placebo	12

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Irritation	Eye disorders	Betaine	0	14	0
other	Irritation	Eye disorders	Placebo	1	13	1
other	GI infection	Gastrointestinal disorders	Betaine	0	14	0
other	GI infection	Gastrointestinal disorders	Placebo	1	13	1
other	GI motility and defecation conditions	Gastrointestinal disorders	Betaine	1	14	1
other	GI motility and defecation conditions	Gastrointestinal disorders	Placebo	0	13	0
other	Hepatic and hepatobiliary disorders	Hepatobiliary disorders	Betaine	1	14	1
other	Hepatic and hepatobiliary disorders	Hepatobiliary disorders	Placebo	0	13	0
other	Immune disorders	Immune system disorders	Betaine	0	14	0
other	Immune disorders	Immune system disorders	Placebo	1	13	1

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Betaine	0	14
Total, all-cause mortality	Placebo	0	13
Total, other adverse events	Betaine	4	14
Total, other adverse events	Placebo	6	13
Total, serious adverse events	Betaine	0	14
Total, serious adverse events	Placebo	0	13

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29860335	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Betaine vs Placebo: deaths from any cause	Trial comparisons
Betaine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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