Insulin SensitivityNCT02118142
Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21
A study testing Betaine and Dextrose in people with Insulin Sensitivity, run by UNC Nutrition Research Institute at 1 site in United States.
Trial summary
People with poor insulin sensitivity do not respond normally to elevations in blood sugar. This may increase their risk of developing diabetes in the future. The purpose of this research study is to determine if the nutrient betaine, found in beets, spinach and wheat products, can enhance the production of fetal… Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- Betaine and Dextrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Able/willing to consume study meals
- Non-smoker
- BMI in normal range (18-24.9)
Who cannot join
- Use of chronic medications
- Abnormal physical examination or chronic illness
- Use of drugs or medications known to alter choline/betaine metabolism
- Consumption of more than 2 oz of alcohol/day or 24 oz wine/day
- Use of choline/betaine-containing dietary supplements during the previous 3 months
- Diagnosed with Cystathionine Beta-Synthase (CBS) Deficiency
Show all 9Show fewer
- Pregnant or breastfeeding
- Known hypersensitivity to betaine
- Current substance abuse or addiction
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Nutrition Research Institute
Kannapolis, North Carolina, 28081
About this study
People with poor insulin sensitivity do not respond normally to elevations in blood sugar. This may increase their risk of developing diabetes in the future. The purpose of this research study is to determine if the nutrient betaine, found in beets, spinach and wheat products, can enhance the production of fetal growth factor 21 (FGF21), a molecule that is believed to promote insulin sensitivity.
Read the detailed description
AIM: To determine if betaine is a modulator of FGF21 in humans. Low plasma betaine is associated with an increased risk of metabolic syndrome, but the mechanisms modulating this correlation are poorly delineated. Betaine bioavailability in humans is determined by dietary intake and genetic polymorphisms that influence betaine metabolism. Therefore, moderating betaine levels could be particularly beneficial for some individuals. FGF21 is elevated in response to insulin insensitivity and is under active investigation as a therapeutic modality. The mechanisms of action of FGF21 and betaine on insulin sensitivity in humans are incompletely understood. This study tests the hypothesis that betaine induces FGF21 secretion and insulin sensitizing actions in humans by measuring plasma FGF21, betaine, choline (betaine precursor), glucose, insulin and adiponectin in response to betaine supplementation over a 24 hour time course in 20 healthy, lean individuals. This pilot nutrition intervention will provide key preliminary evidence for understanding whether and how betaine exerts metabolic benefit in humans and will inform a future study to investigate the novel betaine-FGF21-insulin sensitivity axis in a larger cohort.
- Conditions
- Insulin Sensitivity
- Being tested
- Betaine, Dextrose
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetaineDietary supplement
6 gram one-time dose of betaine delivered in encapsulated form with an unsweetened beverage
DextroseDietary supplement
6 gram one-time dose of dextrose delivered in encapsulated form with an unsweetened beverage
| Study group | Role | What they receive |
|---|---|---|
| Betaine | Active comparator | 6 gram dose of betaine delivered in encapsulated form Receives: Dietary Supplement: Betaine |
| Dextrose | Placebo comparator | 6 gram dose of dextrose delivered in encapsulated form Receives: Dietary Supplement: Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Fetal Growth Factor 21 (FGF21) concentration
Measured: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma choline concentration
Measured: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma betaine concentration
Measured: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma glucose concentration
Measured: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma insulin concentration
Measured: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma adiponectin concentration
Measured: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Secondary outcomes (2)
Typical dietary intake
Assessed via questionnaire
Measured: During day 2 of the first 3 day phase
Typical exercise habits
Assessed via questionnaire
Measured: During day 2 of the first 3 day phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Nutrition Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Corbin, PhD, RD, Principal investigator, UNC Nutrition Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118142
- Sponsor's protocol ID
- 13-2548
- Status last verified
- Aug 2014
- First submitted
- 2 Apr 2014
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21
- ClinicalTrials.gov ID
- NCT02118142
- Acronym / sponsor ID
- 13-2548
- Conditions
- Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- UNC Nutrition Research InstituteUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with poor insulin sensitivity do not respond normally to elevations in blood sugar. This may increase their risk of developing diabetes in the future. The purpose of this research study is to determine if the nutrient betaine, found in beets, spinach and wheat products, can enhance the production of fetal growth factor 21 (FGF21), a molecule that is believed to promote insulin sensitivity.
Detailed description
AIM: To determine if betaine is a modulator of FGF21 in humans. Low plasma betaine is associated with an increased risk of metabolic syndrome, but the mechanisms modulating this correlation are poorly delineated. Betaine bioavailability in humans is determined by dietary intake and genetic polymorphisms that influence betaine metabolism. Therefore, moderating betaine levels could be particularly beneficial for some individuals. FGF21 is elevated in response to insulin insensitivity and is under active investigation as a therapeutic modality. The mechanisms of action of FGF21 and betaine on insulin sensitivity in humans are incompletely understood. This study tests the hypothesis that betaine induces FGF21 secretion and insulin sensitizing actions in humans by measuring plasma FGF21, betaine, choline (betaine precursor), glucose, insulin and adiponectin in response to betaine supplementation over a 24 hour time course in 20 healthy, lean individuals. This pilot nutrition intervention will provide key preliminary evidence for understanding whether and how betaine exerts metabolic benefit in humans and will inform a future study to investigate the novel betaine-FGF21-insulin sensitivity axis in a larger cohort.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betaine | Active comparator | Dietary Supplement: Betaine6 gram dose of betaine delivered in encapsulated form |
| Dextrose | Placebo comparator | Dietary Supplement: Dextrose6 gram dose of dextrose delivered in encapsulated form |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy
- Able/willing to consume study meals
- Non-smoker
- BMI in normal range (18-24.9)
Key exclusion criteria (9 listed)
- Use of chronic medications
- Abnormal physical examination or chronic illness
- Use of drugs or medications known to alter choline/betaine metabolism
- Consumption of more than 2 oz of alcohol/day or 24 oz wine/day
- Use of choline/betaine-containing dietary supplements during the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betaine6 gram one-time dose of betaine delivered in encapsulated form with an unsweetened beverage | Dietary supplement | Betaine |
| Dextrose6 gram one-time dose of dextrose delivered in encapsulated form with an unsweetened beverage | Dietary supplement | Dextrose |
Primary outcome
Plasma Fetal Growth Factor 21 (FGF21) concentration
Time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma choline concentration
Time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma betaine concentration
Time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma glucose concentration
Time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma insulin concentration
Time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma adiponectin concentration
Time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
2 secondary outcomes
Typical dietary intake
Time frame: During day 2 of the first 3 day phase
Typical exercise habits
Time frame: During day 2 of the first 3 day phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Corbin, PhD, RD principal investigator
UNC Nutrition Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betaine and Dextrose in people with Insulin Sensitivity, run by UNC Nutrition Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Fetal Growth Factor 21 (FGF21) concentration (time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014.