Blood Sugar ResponseNCT02763020
Postprandial Glycemic Response to Polyphenol-fortified Snack Bars
A study testing Fruit extracts high in polyphenols in people with Blood Sugar Response, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
Consuming plant chemicals (e.g., polyphenols) may have beneficial effects on human health that, if confirmed, may warrant inclusion in combat rations. Ration developers would like to determine whether the fortification of a high sugar food item with a polyphenol-rich freeze-dried fruit and/or a fruit extract improves… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Sugar Response
- What is being tested?
- Fruit extracts high in polyphenols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Nov 2017
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Soldiers who are stationed with USARIEM, NSRDEC or the U.S. Army Natick Soldier Center pool of military participants, or any civilians will be invited to participate in this study.
Who cannot join
- Potential participants will be excluded from participation if they: are under the age of 18 or over the age of 39 (i.e. insulin sensitivity declines with age, hence the upper age limit of 39 years); have a pre-existing liver disease, history of alcoholism or typically consume more than 4 alcoholic beverages daily or 6 on one occasion more than once a month within the past 6 months; have impaired glucose metabolism due to diabetes, pre-diabetes, galactosemia, hereditary fructose intolerance or glycogen storage disease; have thyroid disease; have a bleeding disorder (e.g., von Willebrand Disease, hemophilia) or are being treated with medication that will impair blood clotting; have a history of GI-related conditions that may impact glucose absorption (e.g., Crohn's disease, ulcerative colitis, Celiac's disease or gluten sensitivity, bariatric surgery or gastroparesis); are taking any medications affecting carbohydrate metabolism (e.g., insulin or oral diabetes medications); and/or, have an allergy or aversion to any of the test foods.
Trial locations and contacts
1 site in 1 country.
About this study
Consuming plant chemicals (e.g., polyphenols) may have beneficial effects on human health that, if confirmed, may warrant inclusion in combat rations. Ration developers would like to determine whether the fortification of a high sugar food item with a polyphenol-rich freeze-dried fruit and/or a fruit extract improves blood sugar response and promotes other positive physiological changes (e.g., satiety) in a dose-response manner. This study will test four different types of snack bar with various polyphenol doses, and compare blood response to a snack bar without polyphenols.
Read the detailed description
High glycemic index (GI) foods generally contain simple sugars and/or highly processed and refined carbohydrates (e.g., instant oatmeal and white bread). These foods are rapidly digested, which raises blood glucose and insulin to higher concentrations and more rapidly compared to low GI food items. In some situations, it is advantageous to consume high glycemic response food items to promote recovery from intense exercise/work. However, there is some suggestion that low/moderate-GI foods may better maintain glucose levels and enhance performance if consumed before and during prolonged exercise. Further, impaired blood glucose regulation (e.g., that can occur with chronic intake of high GI foods) may stimulate the development of oxidative stress, inflammation, dyslipidemia, insulin resistance, and diabetes; and, it is associated with changes in body weight due to stimulating hunger and excessive food intake. These negative consequences are concerning, given the prevalence of overweight/obesity and comorbidities (including metabolic syndrome) within the Department of Defense (DoD). Polyphenols are a heterogeneous group of phytochemicals that are found in plant-based foods; and they have antioxidant and anti-inflammatory properties that may ultimately help protect against chronic diseases, such as cancer and cardiometabolic disease. Berry polyphenols are predominantly comprised of proanthocyanidins and/or ellagitannins (collectively referred to as "tannins"); and, berries have been shown to promote glycemic control when consumed with a high-carbohydrate containing food item. These beneficial health effects may warrant polyphenol fortification of combat rations and Garrison food items. For example, Natick Soldier Research, Development and Engineering Center's (NSRDEC) Combat Feeding Directorate demonstrated that tannins extracted from berries effectively inhibits the activity of enzymes that metabolize starch in vitro, an underlying mechanism for slowing starch digestion in vivo. However, whether consumption of a high GI food item containing polyphenol-rich freeze-dried fruit and/or fruit extracts improves glucose control, reduces oxidative stress, and promotes satiety in human volunteers is unknown. In this randomized, cross-over, placebo-controlled, dose-response trial, at least 20 civilian and/or military personnel will be asked to consume one of five food items during separate trials: 1) a high glycemic snack bar (control) without any fruit ingredients; 2) a high glycemic snack bar with cranberry extract (0.5% total weight); 3) a high glycemic snack bar with cranberry extract (1% total weight); 4) a high glycemic bar with freeze-dried black raspberries (10% total weight); and, 5) a high glycemic snack bar with freeze-dried black raspberries (20% total weight). Serial blood sampling to measure acute changes in circulating glucose, insulin, gastrointestinal hormones and biomarkers of oxidative stress and satiety will occur at baseline and for three hours after consumption of each food. Appetite will also be assessed at an ad libitum meal after the three hour period. The only known risks, which this study presents to participants, are those associated with venous catheter placement. The fruit concentrates for the present study are either commercially available (black raspberry powders) or used as an ingredient to boost the phenolic content of commercial items (cranberry extract). The results will help determine whether fortifying high glycemic food items with polyphenols may benefit the Warfighter in the ration- or Garrison-feeding environment.
- Conditions
- Blood Sugar Response
- Being tested
- Fruit extracts high in polyphenols, placebo
- Keywords
- high glycemic index, polyphenols, blood glucose, satiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit extracts high in polyphenolsOther
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Food bar without fruit | Placebo comparator | snack bar without fruit Receives: Other: placebo |
| Food bar with cranberry extract (0.5%) | Experimental | Snack bar with cranberry extract (0.5% total weight) Receives: Other: Fruit extracts high in polyphenols |
| Food bar with cranberry extract (1.0%) | Experimental | Snack bar with cranberry extract (1.0% total weight) Receives: Other: Fruit extracts high in polyphenols |
| Food bar w/ dried black raspberry (10%) | Experimental | Snack bar with freeze-dried black raspberry(10% total weight) Receives: Other: Fruit extracts high in polyphenols |
| Food bar w/ dried black raspberry (20%) | Experimental | Snack bar with freeze-dried black raspberry (20% total weight) Receives: Other: Fruit extracts high in polyphenols |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose concentrations
Measured: fasting and post-prandial (every 15 minutes for the first hour and every half hour for the last two hours)
Secondary outcomes (2)
gut hormones
Measured: fasting and post-prandial (every 15 minutes for the first hour and every half hour for the last two hours)
blood concentration of phenolic acids
Measured: fasting, post-prandial 60 minutes, 120 minutes and 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Sugar ResponseStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Tracey J Smith, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763020
- Sponsor's protocol ID
- 15-28-HC
- Status last verified
- Dec 2017
- First submitted
- 3 May 2016
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Glycemic Response to Polyphenol-fortified Snack Bars
- ClinicalTrials.gov ID
- NCT02763020
- Acronym / sponsor ID
- 15-28-HC
- Conditions
- Blood Sugar Response
- Keywords
- high glycemic index, polyphenols, blood glucose, satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 5 May 2016 (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.
Consuming plant chemicals (e.g., polyphenols) may have beneficial effects on human health that, if confirmed, may warrant inclusion in combat rations. Ration developers would like to determine whether the fortification of a high sugar food item with a polyphenol-rich freeze-dried fruit and/or a fruit extract improves blood sugar response and promotes other positive physiological changes (e.g., satiety) in a dose-response manner. This study will test four different types of snack bar with various polyphenol doses, and compare blood response to a snack bar without polyphenols.
Detailed description
High glycemic index (GI) foods generally contain simple sugars and/or highly processed and refined carbohydrates (e.g., instant oatmeal and white bread). These foods are rapidly digested, which raises blood glucose and insulin to higher concentrations and more rapidly compared to low GI food items. In some situations, it is advantageous to consume high glycemic response food items to promote recovery from intense exercise/work. However, there is some suggestion that low/moderate-GI foods may better maintain glucose levels and enhance performance if consumed before and during prolonged exercise. Further, impaired blood glucose regulation (e.g., that can occur with chronic intake of high GI foods) may stimulate the development of oxidative stress, inflammation, dyslipidemia, insulin resistance, and diabetes; and, it is associated with changes in body weight due to stimulating hunger and excessive food intake. These negative consequences are concerning, given the prevalence of overweight/obesity and comorbidities (including metabolic syndrome) within the Department of Defense (DoD). Polyphenols are a heterogeneous group of phytochemicals that are found in plant-based foods; and they have antioxidant and anti-inflammatory properties that may ultimately help protect against chronic diseases, such as cancer and cardiometabolic disease. Berry polyphenols are predominantly comprised of proanthocyanidins and/or ellagitannins (collectively referred to as "tannins"); and, berries have been shown to promote glycemic control when consumed with a high-carbohydrate containing food item. These beneficial health effects may warrant polyphenol fortification of combat rations and Garrison food items. For example, Natick Soldier Research, Development and Engineering Center's (NSRDEC) Combat Feeding Directorate demonstrated that tannins extracted from berries effectively inhibits the activity of enzymes that metabolize starch in vitro, an underlying mechanism for slowing starch digestion in vivo. However, whether consumption of a high GI food item containing polyphenol-rich freeze-dried fruit and/or fruit extracts improves glucose control, reduces oxidative stress, and promotes satiety in human volunteers is unknown. In this randomized, cross-over, placebo-controlled, dose-response trial, at least 20 civilian and/or military personnel will be asked to consume one of five food items during separate trials: 1) a high glycemic snack bar (control) without any fruit ingredients; 2) a high glycemic snack bar with cranberry extract (0.5% total weight); 3) a high glycemic snack bar with cranberry extract (1% total weight); 4) a high glycemic bar with freeze-dried black raspberries (10% total weight); and, 5) a high glycemic snack bar with freeze-dried black raspberries (20% total weight). Serial blood sampling to measure acute changes in circulating glucose, insulin, gastrointestinal hormones and biomarkers of oxidative stress and satiety will occur at baseline and for three hours after consumption of each food. Appetite will also be assessed at an ad libitum meal after the three hour period. The only known risks, which this study presents to participants, are those associated with venous catheter placement. The fruit concentrates for the present study are either commercially available (black raspberry powders) or used as an ingredient to boost the phenolic content of commercial items (cranberry extract). The results will help determine whether fortifying high glycemic food items with polyphenols may benefit the Warfighter in the ration- or Garrison-feeding environment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Food bar without fruit | Placebo comparator | Other: placebosnack bar without fruit |
| Food bar with cranberry extract (0.5%) | Experimental | Other: Fruit extracts high in polyphenolsSnack bar with cranberry extract (0.5% total weight) |
| Food bar with cranberry extract (1.0%) | Experimental | Other: Fruit extracts high in polyphenolsSnack bar with cranberry extract (1.0% total weight) |
| Food bar w/ dried black raspberry (10%) | Experimental | Other: Fruit extracts high in polyphenolsSnack bar with freeze-dried black raspberry(10% total weight) |
| Food bar w/ dried black raspberry (20%) | Experimental | Other: Fruit extracts high in polyphenolsSnack bar with freeze-dried black raspberry (20% total weight) |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Soldiers who are stationed with USARIEM, NSRDEC or the U.S. Army Natick Soldier Center pool of military participants, or any civilians will be invited to participate in this study.
Key exclusion criteria (1 listed)
- Potential participants will be excluded from participation if they: are under the age of 18 or over the age of 39 (i.e. insulin sensitivity declines with age, hence the upper age limit of 39 years); have a pre-existing liver disease, history of alcoholism or typically consume more than 4 alcoholic beverages daily or 6 on one occasion more than once a month within the past 6 months; have impaired glucose metabolism due to diabetes, pre-diabetes, galactosemia, hereditary fructose intolerance or glycogen storage disease; have thyroid disease; have a bleeding disorder (e.g., von Willebrand Disease, hemophilia) or are being treated with medication that will impair blood clotting; have a history of GI-related conditions that may impact glucose absorption (e.g., Crohn's disease, ulcerative colitis, Celiac's disease or gluten sensitivity, bariatric surgery or gastroparesis); are taking any medications affecting carbohydrate metabolism (e.g., insulin or oral diabetes medications); and/or, have an allergy or aversion to any of the test foods.
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 |
|---|---|---|
| Fruit extracts high in polyphenols | Other | Food bar w/ dried black raspberry (10%), Food bar w/ dried black raspberry (20%), Food bar with cranberry extract (0.5%), Food bar with cranberry extract (1.0%) |
| placebo | Other | Food bar without fruit |
Primary outcome
blood glucose concentrations
Time frame: fasting and post-prandial (every 15 minutes for the first hour and every half hour for the last two hours)
2 secondary outcomes
gut hormones
Time frame: fasting and post-prandial (every 15 minutes for the first hour and every half hour for the last two hours)
blood concentration of phenolic acids
Time frame: fasting, post-prandial 60 minutes, 120 minutes and 180 minutes
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 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Tracey J Smith, PhD principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit extracts high in polyphenols in people with Blood Sugar Response, run by United States Army Research Institute of Environmental Medicine 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 1 inclusion and 1 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 Dec 2017. 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?
blood glucose concentrations (time frame: fasting and post-prandial (every 15 minutes for the first hour and every half hour for the last two hours)). 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 Dec 2017.