HealthySAACNCT03611972
Sucrose-sweetened Beverage in African-American and Caucasian Women.
A study testing Sugar-sweetened beverage in people with Healthy, run by University of California, Davis at 2 sites in United States.
Trial summary
The main objective of this pilot study is to measure changes in metabolic risk factors of cardiovascular disease and type 2 diabetes in response to sugar-sweetened beverages in African-American and non-Hispanic white women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sugar-sweetened beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Aug 2018to 30 Mar 2022
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25 - 35 kg/m2
Who cannot join
- Does not identify as African-American or non-hispanic White
- Glucose intolerance (fasting glucose >100 mg/dl)
- Evidence of liver disorder (AST or ALT >200% upper limit of normal range)
- Evidence of kidney disorder (>2.0mg/dl creatinine)
- Evidence of thyroid disorder (out of normal range)
- Systolic blood pressure consistently over 140mmHg or diastolic blood pressure over 90mmHg
Show all 24Show fewer
- Triglycerides > 150mg/dl
- LDL-C > 130mg/dl
- Hemoglobin < 8.5 g/dL
- Pregnant or lactating women
- Current, prior (within 12 months), or anticipated use of any hypolipidemic or anti-diabetic agents PROTOCOL TITLE: The Effects of Sucrose Beverage on African-American and Caucasian Women (SAAC) Study Page 4 of 18 Revised: November 27, 2013
- Use of thyroid, anti-hypertensive, anti-depressant, weight loss medications or any other medication which, in the opinion of the investigator, may confound study results
- Use of chronic corticosteroids (everyday use for a month or longer)
- Use of tobacco
- Strenuous exerciser (>3.5 hours/week at a level more vigorous than walking)
- Surgery for weight loss
- Diet exclusions: Food allergies, special dietary restrictions, food allergies, routine consumption of less than 3 meals/day, routine ingestion of more than 2 sugar-sweetened beverages or 1 alcoholic beverage/day, unwillingness to consume any food on study menu
- Veins that are assessed by the CCRC R.N.s as being unsuitable for long-term infusions and multiple blood draws from a catheter
- Any other condition that, in the opinion of the investigators, would put the subject at risk
- We will exclude individuals from each of the following special populations:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers < 18 years)
- Pregnant women
- Prisoners
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Davis
Davis, California, 95616
University of California, Davis CTSC Clinical Research Center
Sacramento, California, 95817
About this study
Official title: Effects of Sucrose-sweetened Beverage in African-American and Caucasian Women.
The main objective of this pilot study is to measure changes in metabolic risk factors of cardiovascular disease and type 2 diabetes in response to sugar-sweetened beverages in African-American and non-Hispanic white women.
Read the detailed description
This is a dietary intervention during which participants will consume a SSB daily, with each meal for two weeks. At the beginning and end of the two-week intervention, participants will have blood drawn under fasting and postprandial (after a meal) conditions for the measurement of lipid risk factors associated with cardiovascular disease. Participants will also undergo an oral glucose tolerance test (OGTT) to assess insulin sensitivity. All sugar-sweetened beverages will be provided.
- Conditions
- Healthy
- Being tested
- Sugar-sweetened beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar-sweetened beverageDietary supplement
Sugar-sweetened koolaid-flavored water.
| Study group | Role | What they receive |
|---|---|---|
| Sugar-sweetened beverage (SSB) | Experimental | SSB provided at 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 2 weeks Receives: Dietary Supplement: Sugar-sweetened beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglycerides
Fasting and postprandial plasma triglycerides
Measured: 2 weeks
Total cholesterol
Fasting and postprandial plasma cholesterol
Measured: 2 weeks
Low-density lipoprotein (LDL)
Fasting and postprandial plasma low-density lipoprotein (LDL)
Measured: 2 weeks
Oral glucose tolerance test (OGTT)
Participants will drink a beverage containing 75g of glucose and blood will be drawn before the drink and at 30 minutes, 60 minutes, 90 minutes, 120 minutes and 180 minutes after the drink. Plasma glucose and insulin will be measured at each time point.
Measured: 2 weeks
Secondary outcomes (1)
Waist circumference
Waist circumference
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start20 Aug 2018
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Why it stopped: PI resigned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Dietary intervention
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Office of Research on Women's Health (ORWH), National Center for Advancing Translational Sciences (NCATS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Candice Price, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611972
- Sponsor's protocol ID
- 1243331
- Other IDs
- K12HD051958, UL1TR001860
- Acronym
- SAAC
- Status last verified
- Jun 2023
- First submitted
- 27 Jul 2018
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sucrose-sweetened Beverage in African-American and Caucasian Women.
- ClinicalTrials.gov ID
- NCT03611972
- Acronym / sponsor ID
- SAAC / 1243331
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI resigned
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Office of Research on Women's Health (ORWH), National Center for Advancing Translational Sciences (NCATS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 2 Aug 2018 (actual)
- 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.
The main objective of this pilot study is to measure changes in metabolic risk factors of cardiovascular disease and type 2 diabetes in response to sugar-sweetened beverages in African-American and non-Hispanic white women.
Detailed description
This is a dietary intervention during which participants will consume a SSB daily, with each meal for two weeks. At the beginning and end of the two-week intervention, participants will have blood drawn under fasting and postprandial (after a meal) conditions for the measurement of lipid risk factors associated with cardiovascular disease. Participants will also undergo an oral glucose tolerance test (OGTT) to assess insulin sensitivity. All sugar-sweetened beverages will be provided.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dietary intervention
| Arm | Type | Receives |
|---|---|---|
| Sugar-sweetened beverage (SSB) | Experimental | Dietary Supplement: Sugar-sweetened beverageSSB provided at 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 2 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 25 - 35 kg/m2
Key exclusion criteria (24 listed)
- Does not identify as African-American or non-hispanic White
- Glucose intolerance (fasting glucose >100 mg/dl)
- Evidence of liver disorder (AST or ALT >200% upper limit of normal range)
- Evidence of kidney disorder (>2.0mg/dl creatinine)
- Evidence of thyroid disorder (out of normal range)
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 |
|---|---|---|
| Sugar-sweetened beverageSugar-sweetened koolaid-flavored water. | Dietary supplement | Sugar-sweetened beverage (SSB) |
Primary outcome
Triglycerides
Time frame: 2 weeks
Fasting and postprandial plasma triglycerides
Total cholesterol
Time frame: 2 weeks
Fasting and postprandial plasma cholesterol
Low-density lipoprotein (LDL)
Time frame: 2 weeks
Fasting and postprandial plasma low-density lipoprotein (LDL)
Oral glucose tolerance test (OGTT)
Time frame: 2 weeks
Participants will drink a beverage containing 75g of glucose and blood will be drawn before the drink and at 30 minutes, 60 minutes, 90 minutes, 120 minutes and 180 minutes after the drink. Plasma glucose and insulin will be measured at each time point.
1 secondary outcome
Waist circumference
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: PI resigned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Learn more or sign up for the study here!Link provided by the sponsor.
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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.
Candice Price, PhD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar-sweetened beverage in people with Healthy, run by University of California, Davis at 2 sites 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 1 inclusion and 24 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: stopped early, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 was stopped early (reason given: PI resigned). Results are not available in the source record.
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?
Triglycerides (time frame: 2 weeks). The study lists 4 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 15 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.