Healthy VolunteersNCT03458858
Berry Components and Blood Sugar & Fat Metabolism
A study testing Mixed Berry Diet, Fiber Enriched Jello and Low Fiber Mixed Berry Juice in people with Healthy Volunteers, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial summary
The primary objective of this study is to determine which components of berries improve glucose metabolism and increase fat oxidation in humans. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Mixed Berry Diet, Fiber Enriched Jello and Low Fiber Mixed Berry Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2018to 28 Jun 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy non-smoker
- able to understand consent
Who cannot join
- Body Mass Index less than 25 kg/m2
- pregnant, lactating, having given birth in the past year
- allergy to berries
- blood glucose greater than 125 mg/dL
- history of bariatric surgery or nutrient malabsorption disease
- diagnosis or treatment of cancer in past three years
- type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA-ARS Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
The primary objective of this study is to determine which components of berries improve glucose metabolism and increase fat oxidation in humans.
Read the detailed description
The aim of this study is to improve understanding of how diet can regulate glucose metabolism and fuel use. Previous human and animal studies have demonstrated that berries can improve gluco-regulation and increase fat oxidation. The aim of this study is to determine which component of berries is conveying this health benefit.
- Conditions
- Healthy Volunteers
- Being tested
- Mixed Berry Diet, Carbohydrate Control Jello, Fiber Enriched Jello, Low Fiber Mixed Berry Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Berry DietOther
Mixed Berry Treatment
Carbohydrate Control JelloOther
Carbohydrate Control
Fiber Enriched JelloOther
Fiber Control
Low Fiber Mixed Berry JuiceOther
Anthocyanin Control
| Study group | Role | What they receive |
|---|---|---|
| Mixed Berry Diet | Other | Participants will receive between 400 to 800 grams of mixed berries daily, as a proportion of their daily caloric intake added to their base diet. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. Receives: Other: Mixed Berry Diet |
| Carbohydrate Control Jello | Other | Participants will receive between 400 to 800 grams of strawberry jello daily, as a proportion of their daily caloric intake added to their base diet. The jello will be matched to the mixed berries in both total carbohydrate level and gram quantity. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. Receives: Other: Carbohydrate Control Jello |
| Fiber Enriched Jello | Other | Participants will receive between 400 to 800 grams of fiber enriched strawberry jello daily, as a proportion of their daily caloric intake added to their base diet. The jello will be matched to the mixed berries in both total carbohydrate level and fiber content, and in the same gram quantity. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. Receives: Other: Fiber Enriched Jello |
| Low Fiber Mixed Berry Juice | Other | Participants will receive 1 liter per day of low fiber mixed berry juice added to their base diet. The juice will be squeezed from the mixed berries, then filtered. The sugar level of the juice will match that of the mixed berries. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. Receives: Other: Low Fiber Mixed Berry Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Metabolism Phase 1
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.
Measured: Day 8
Glucose Metabolism Phase 2
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.
Measured: Day 29
Glucose Metabolism Phase 3
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.
Measured: Day 50
Glucose Metabolism Phase 4
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.
Measured: Day 71
Secondary outcomes (4)
Insulin sensitivity
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for insulin in units of microIU/mL.
Measured: Day 8, 29, 50, 71
Fat trafficking
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for non-esterified fatty acids in mmol/L.
Measured: Day 8, 29, 50, 71
Peripheral mononuclear blood cells energetics
Blood cells called peripheral mononuclear blood cells will be isolated and analyzed for mitochondrial function/oxygen consumption in nmol/ml.
Measured: Day 8, 29, 50, 71
Metabolic Fuel Use
Subjects will spend the night in an indirect calorimeter to measure their oxygen consumption and carbon dioxide evolution which will be used to calculate the dietary energy source being oxidized, expressed as respiratory quotient which is a unitless ratio of liters of O2 inhaled to liters of CO2 exhaled.
Measured: Day 7-8, 28-29, 49-50, 70-71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start13 Feb 2018
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Janet Novotny, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458858
- Sponsor's protocol ID
- HS59
- Status last verified
- May 2019
- First submitted
- 3 Jan 2018
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Berry Components and Blood Sugar & Fat Metabolism
- ClinicalTrials.gov ID
- NCT03458858
- Acronym / sponsor ID
- HS59
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 8 Mar 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 primary objective of this study is to determine which components of berries improve glucose metabolism and increase fat oxidation in humans.
Detailed description
The aim of this study is to improve understanding of how diet can regulate glucose metabolism and fuel use. Previous human and animal studies have demonstrated that berries can improve gluco-regulation and increase fat oxidation. The aim of this study is to determine which component of berries is conveying this health benefit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mixed Berry Diet | Other | Other: Mixed Berry DietParticipants will receive between 400 to 800 grams of mixed berries daily, as a proportion of their daily caloric intake added to their base diet. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. |
| Carbohydrate Control Jello | Other | Other: Carbohydrate Control JelloParticipants will receive between 400 to 800 grams of strawberry jello daily, as a proportion of their daily caloric intake added to their base diet. The jello will be matched to the mixed berries in both total carbohydrate level and gram quantity. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. |
| Fiber Enriched Jello | Other | Other: Fiber Enriched JelloParticipants will receive between 400 to 800 grams of fiber enriched strawberry jello daily, as a proportion of their daily caloric intake added to their base diet. The jello will be matched to the mixed berries in both total carbohydrate level and fiber content, and in the same gram quantity. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. |
| Low Fiber Mixed Berry Juice | Other | Other: Low Fiber Mixed Berry JuiceParticipants will receive 1 liter per day of low fiber mixed berry juice added to their base diet. The juice will be squeezed from the mixed berries, then filtered. The sugar level of the juice will match that of the mixed berries. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy non-smoker
- able to understand consent
Key exclusion criteria (7 listed)
- Body Mass Index less than 25 kg/m2
- pregnant, lactating, having given birth in the past year
- allergy to berries
- blood glucose greater than 125 mg/dL
- history of bariatric surgery or nutrient malabsorption disease
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 |
|---|---|---|
| Mixed Berry DietMixed Berry Treatment | Other | Mixed Berry Diet |
| Carbohydrate Control JelloCarbohydrate Control | Other | Carbohydrate Control Jello |
| Fiber Enriched JelloFiber Control | Other | Fiber Enriched Jello |
| Low Fiber Mixed Berry JuiceAnthocyanin Control | Other | Low Fiber Mixed Berry Juice |
Primary outcome
Glucose Metabolism Phase 1
Time frame: Day 8
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.
Glucose Metabolism Phase 2
Time frame: Day 29
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.
Glucose Metabolism Phase 3
Time frame: Day 50
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.
Glucose Metabolism Phase 4
Time frame: Day 71
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.
4 secondary outcomes
Insulin sensitivity
Time frame: Day 8, 29, 50, 71
Fat trafficking
Time frame: Day 8, 29, 50, 71
Peripheral mononuclear blood cells energetics
Time frame: Day 8, 29, 50, 71
Metabolic Fuel Use
Time frame: Day 7-8, 28-29, 49-50, 70-71
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 7 May 2019.
- Individual participant dataSharing planned: No
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Screening Protocol
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Berry Diet, Fiber Enriched Jello and Low Fiber Mixed Berry Juice in people with Healthy Volunteers, run by USDA Beltsville Human Nutrition Research Center 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 2 inclusion and 7 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 7 May 2019. 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. 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?
Glucose Metabolism Phase 1 (time frame: Day 8). 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 7 May 2019.