HyperlipidemiaNCT02366156
A 12 Week, 3-Period Study to Evaluate the Effects of a Dietary Supplement on Lipid Metabolism
A study testing Low Dose Grape Blend and High Dose Grape Blend in people with Hyperlipidemia, run by Access Business Group at 1 site in United States.
Trial summary
This study will evaluate the effects of encapsulated botanical extracts, previously shown to inhibit the enzyme diacylglycerol-acyltransferase-1 (DGAT-1) in vitro, on fasting and postprandial lipid metabolism during an oral fat tolerance test (OFTT) in apparently healthy, overweight and obese adult men and women. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Low Dose Grape Blend and High Dose Grape Blend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Mar 2015
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is male or female, 18-70 years of age, inclusive.
- Subject has a fasting TG concentration of ≥150 and <500 mg/dL at visit 1b (week -1). One venous retest allowed for 145-149 and 500-550 mg/dL values.
- Subject has a body mass index (BMI) of 25.00-34.99 kg/m2 at visit 1b (week -1).
- Subject is willing to maintain habitual diet and physical activity patterns during the study period.
- Subject has no plans to change smoking habits during the study period, and if a current smoker, subject is willing to refrain from all tobacco products for 1 h prior to all clinic visits in addition to up to 9 h during the test visits.
- Subject has a score of 7 to 10 on the Vein Access Scale at screening visit (visit 1b, week -1).
- Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Subject has abnormal laboratory test results of clinical significance at visit 1b (week -1), at the discretion of the Investigator. One re-test will be allowed on a separate day prior to visit 2 (week 0), for subjects with abnormal laboratory test results.
- Subject has a history or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric or biliary disorders.
- Subject has a history or current GI disorder that, in the judgment of the Investigator, may have the potential to disrupt normal digestion and absorption of dietary fats, including, but not limited to, Crohn's disease, inflammatory bowel disease, irritable bowel syndrome, significant lactose intolerance and/or egg allergy.
- Subject has a known genetic predisposition to hyperlipidemia - as diagnosed by a health care professional.
- Subject is a heavy smoker, defined as a history of smoking >1 pack-per-day in the 3 months prior to visit 1b (week -1).
- Subject has a history of difficulty swallowing tablets/capsules that could affect ability to consume the study product.Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
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- Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Investigator.
- Subject has had a weight loss or gain >4.5 kg in the 3 months prior to visit 1b (week -1).
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at visit 1b (week -1). One re-test will be allowed on a separate day prior to visit 2 (week 0), for subjects whose blood pressure exceeds either of these cut points, in the judgment of the Investigator.
- Subject has not been on a stable dose of antihypertensive medication (at least 4 weeks prior to visit 1b, week -1 and for the duration of the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, 3-Period Crossover Study to Evaluate the Effects of a Dietary Supplement Containing Botanical Extracts on Fasting and Postprandial Lipid Metabolism in Apparently Healthy, Overweight and Obese Individuals
This study will evaluate the effects of encapsulated botanical extracts, previously shown to inhibit the enzyme diacylglycerol-acyltransferase-1 (DGAT-1) in vitro, on fasting and postprandial lipid metabolism during an oral fat tolerance test (OFTT) in apparently healthy, overweight and obese adult men and women.
Read the detailed description
Medications currently approved for the treatment of obesity act primarily to promote a state of energy balance - by either suppressing appetite or interfering with lipid absorption in the small intestine. Similarly, it may be possible to reduce or inhibit the synthesis of triglycerides (TG) from dietary fat by targeting the activity of diacylglycerol-acyltransferase-1 (DGAT-1) in the enterocytes of the small intestine.
DGAT-1 catalyzes the final step in the biosynthesis of TG and is most abundantly expressed in the small intestine and adipose tissue. DGAT-1 in enterocytes is critical for assembly of TG from fatty acids derived from food intake. Ingested dietary fat is cleaved to monoacylglycerol and free fatty acids by lipases in the gut lumen and these are next taken up by the enterocytes, where they are re-esterified to TG in the postprandial period. TG is eventually released into circulation, primarily transported by chylomicrons. Thus, DGAT-1 plays a critical role in the absorption of dietary fat and inhibition of DGAT-1 has been shown to delay and decrease re-esterification of dietary fats into circulating TG. It is hypothesized that this effect may lead to decreased deposition of excess dietary fat as adipose tissue, perhaps due to increased fatty acid oxidation in the enterocytes.
The potential physiological benefits of DGAT-1 inhibition lead to the development of the potent, selective DGAT-1 inhibitor, AZD7687. Human clinical trials of AZD7687 demonstrated attenuation of postprandial TG excursions, consistent with inhibition of gut DGAT-1. However, this compound has limited, if any, therapeutic potential due to profound gastrointestinal (GI) side effects, particularly diarrhea, nausea, and abdominal cramping which were deemed intolerable. Moreover, no consistent dose-related treatment effects on body weight, glucose or lipid metabolism were found in the small trials which were deemed to be non-representative of the target therapeutic population.
Both cell-free and cellular in vitro models have been used to identify botanical extracts that have potential to inhibit DGAT-1. In a follow-up 7-d parallel arm proof-of-mechanism human clinical trial, each of four lead ingredients (2 g/d) were evaluated for the ability to inhibit the intestinal release of dietary fat into circulation following a high-fat meal challenge using post-prandial TG response as a surrogate marker. Of the four lead botanical ingredients, whole grape extract (WGE) reduced fasting and postprandial TG levels (total area under the curve from 0 to 6 h) by ~ 7% to 8% following a high-fat meal challenge. This demonstration of efficacy, albeit modest, was sufficient to warrant continued exploration. Importantly, only a few subjects reported very mild GI side effects, primarily bloating, in this trial.
Combinations of WGE with other botanical extracts possessing biological activity against supportive secondary mechanisms that might strengthen the overall inhibition of dietary fat release into circulation and fat deposition were then explored. To examine potential synergistic interactions, WGE was combined with other ingredients known to act on complementary biological pathways that converge into a single efficacy outcome; in this case, cellular TG levels. Ingredients that had effects on both glucose and fatty acid metabolism that could ultimately synergize with the DGAT-1 pathway were chosen. The complementary pathway targets chosen for these experiments were Peroxisome-Proliferator-Activated Receptor-gamma Coactivator 1-alpha (PGC1-α) and Sterol Regulatory Element Binding Protein 1c (SREBP1c).
In the cellular DGAT-1 model, grape seed extract (GSE) resulted in a significant inhibition of DGAT-1 activity when combined with WGE. The combination index (CI), a quantitative measure of synergy, indicated a strong synergistic effect (CI = 0.61). Synergy occurred at a 1:1 ratio of WGE to GSE, and at ratios that induced no effect on DGAT-1 activity when either was used alone. The synergy data, together with the proof of mechanism clinical data, forms the basis for conducting the presently proposed clinical trial at a WGE level below that used in the previous study.
- Conditions
- Hyperlipidemia
- Being tested
- Placebo, Low Dose Grape Blend, High Dose Grape Blend
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Three placebo capsules consumed prior to breakfast each day for 4 weeks
Low Dose Grape BlendDietary supplement
Three low dose grape blend capsules consumed prior to breakfast each day for 4 weeks.
High Dose Grape BlendDietary supplement
Three high dose grape blend capsules consumed prior to breakfast each day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Inactive capsules Receives: Dietary Supplement: Placebo |
| Low Dose Grape Blend | Active comparator | Low dose grape blend providing 375 mg whole grape extract + 375 mg grape seed extract/d (750 mg total botanical extracts/d). Receives: Dietary Supplement: Low Dose Grape Blend |
| High Dose Grape Blend | Active comparator | High dose grape blend providing 500 mg whole grape extract + 500 mg grape seed extract/d (1000 mg total botanical extracts/d) Receives: Dietary Supplement: High Dose Grape Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting triglycerides
Change in fasting plasma TG
Measured: Baseline and at the end of each 4 week treatment period for a total of 12 weeks
Secondary outcomes (5)
Area under the curve (AUC) for plasma TG
Change in the total AUC for plasma TG from 0 to 8 hours following a high fat meal challenge.
Measured: Baseline and the end of each 4 week treatment period for a total of 12 weeks
Maximal Concentration (Cmax) and time to Cmax (Tmax)
Change in Cmax and Tmax for plasma TG for up to 8 hours following a high fat meal challenge.
Measured: Baseline and at the end of each 4 week treatment period for a total to 12 weeks
Plasma TG during the OFTT
Change in plasma TG at 2, 4, 6, and 8 hours following a high fat meal challenge.
Measured: Baseline and at the end of each 4 week treatment period for a total of 12 weeks
Fasting lipoprotein lipids
Change in fasting lipoprotein lipids, including high-density lipoprotein cholesterol (HDL-C), non-HDL-C, low-density lipoprotein cholesterol (LDL-C), and total cholesterol (TC).
Measured: Baseline and at the end of each 4 week treatment period for a total of 12 weeks
Body weight
Change in body weight
Measured: Baseline and at the end of each 4 week treatment period for a total of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access Business Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Lawson, MD, Principal investigator, Biofortis; 211 East Lake Street; Addison, IL 60101
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366156
- Sponsor's protocol ID
- BIO-1403
- Status last verified
- Mar 2015
- First submitted
- 15 Oct 2014
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ables GP, Yang KJ, Vogel S, Hernandez-Ono A, Yu S, Yuen JJ, Birtles S, Buckett LK, Turnbull AV, Goldberg IJ, Blaner WS, Huang LS, Ginsberg HN. Intestinal DGAT1 deficiency reduces postprandial triglyceride and retinyl ester excursions by inhibiting chylomicron secretion and delaying gastric emptying. J Lipid Res. 2012 Nov;53(11):2364-79. doi: 10.1194/jlr.M029041. Epub 2012 Aug 21.
PubMed 22911105Cheng D, Iqbal J, Devenny J, Chu CH, Chen L, Dong J, Seethala R, Keim WJ, Azzara AV, Lawrence RM, Pelleymounter MA, Hussain MM. Acylation of acylglycerols by acyl coenzyme A:diacylglycerol acyltransferase 1 (DGAT1). Functional importance of DGAT1 in the intestinal fat absorption. J Biol Chem. 2008 Oct 31;283(44):29802-11. doi: 10.1074/jbc.M800494200. Epub 2008 Sep 3.
PubMed 18768481Chun OK, Chung SJ, Song WO. Estimated dietary flavonoid intake and major food sources of U.S. adults. J Nutr. 2007 May;137(5):1244-52. doi: 10.1093/jn/137.5.1244.
PubMed 17449588Denison H, Nilsson C, Kujacic M, Lofgren L, Karlsson C, Knutsson M, Eriksson JW. Proof of mechanism for the DGAT1 inhibitor AZD7687: results from a first-time-in-human single-dose study. Diabetes Obes Metab. 2013 Feb;15(2):136-43. doi: 10.1111/dom.12002. Epub 2012 Sep 30.
PubMed 22950654Martin SS, Blaha MJ, Elshazly MB, Toth PP, Kwiterovich PO, Blumenthal RS, Jones SR. Comparison of a novel method vs the Friedewald equation for estimating low-density lipoprotein cholesterol levels from the standard lipid profile. JAMA. 2013 Nov 20;310(19):2061-8. doi: 10.1001/jama.2013.280532.
PubMed 24240933Swinburn BA, Sacks G, Hall KD, McPherson K, Finegood DT, Moodie ML, Gortmaker SL. The global obesity pandemic: shaped by global drivers and local environments. Lancet. 2011 Aug 27;378(9793):804-14. doi: 10.1016/S0140-6736(11)60813-1.
PubMed 21872749Yen CL, Stone SJ, Koliwad S, Harris C, Farese RV Jr. Thematic review series: glycerolipids. DGAT enzymes and triacylglycerol biosynthesis. J Lipid Res. 2008 Nov;49(11):2283-301. doi: 10.1194/jlr.R800018-JLR200. Epub 2008 Aug 29.
PubMed 18757836
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, 3-Period Crossover Study to Evaluate the Effects of a Dietary Supplement Containing Botanical Extracts on Fasting and Postprandial Lipid Metabolism in Apparently Healthy, Overweight and Obese Individuals
- ClinicalTrials.gov ID
- NCT02366156
- Acronym / sponsor ID
- BIO-1403
- Conditions
- Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Access Business GroupIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Feb 2015 (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.
This study will evaluate the effects of encapsulated botanical extracts, previously shown to inhibit the enzyme diacylglycerol-acyltransferase-1 (DGAT-1) in vitro, on fasting and postprandial lipid metabolism during an oral fat tolerance test (OFTT) in apparently healthy, overweight and obese adult men and women.
Detailed description
Medications currently approved for the treatment of obesity act primarily to promote a state of energy balance - by either suppressing appetite or interfering with lipid absorption in the small intestine. Similarly, it may be possible to reduce or inhibit the synthesis of triglycerides (TG) from dietary fat by targeting the activity of diacylglycerol-acyltransferase-1 (DGAT-1) in the enterocytes of the small intestine.
DGAT-1 catalyzes the final step in the biosynthesis of TG and is most abundantly expressed in the small intestine and adipose tissue. DGAT-1 in enterocytes is critical for assembly of TG from fatty acids derived from food intake. Ingested dietary fat is cleaved to monoacylglycerol and free fatty acids by lipases in the gut lumen and these are next taken up by the enterocytes, where they are re-esterified to TG in the postprandial period. TG is eventually released into circulation, primarily transported by chylomicrons. Thus, DGAT-1 plays a critical role in the absorption of dietary fat and inhibition of DGAT-1 has been shown to delay and decrease re-esterification of dietary fats into circulating TG. It is hypothesized that this effect may lead to decreased deposition of excess dietary fat as adipose tissue, perhaps due to increased fatty acid oxidation in the enterocytes.
The potential physiological benefits of DGAT-1 inhibition lead to the development of the potent, selective DGAT-1 inhibitor, AZD7687. Human clinical trials of AZD7687 demonstrated attenuation of postprandial TG excursions, consistent with inhibition of gut DGAT-1. However, this compound has limited, if any, therapeutic potential due to profound gastrointestinal (GI) side effects, particularly diarrhea, nausea, and abdominal cramping which were deemed intolerable. Moreover, no consistent dose-related treatment effects on body weight, glucose or lipid metabolism were found in the small trials which were deemed to be non-representative of the target therapeutic population.
Both cell-free and cellular in vitro models have been used to identify botanical extracts that have potential to inhibit DGAT-1. In a follow-up 7-d parallel arm proof-of-mechanism human clinical trial, each of four lead ingredients (2 g/d) were evaluated for the ability to inhibit the intestinal release of dietary fat into circulation following a high-fat meal challenge using post-prandial TG response as a surrogate marker. Of the four lead botanical ingredients, whole grape extract (WGE) reduced fasting and postprandial TG levels (total area under the curve from 0 to 6 h) by ~ 7% to 8% following a high-fat meal challenge. This demonstration of efficacy, albeit modest, was sufficient to warrant continued exploration. Importantly, only a few subjects reported very mild GI side effects, primarily bloating, in this trial.
Combinations of WGE with other botanical extracts possessing biological activity against supportive secondary mechanisms that might strengthen the overall inhibition of dietary fat release into circulation and fat deposition were then explored. To examine potential synergistic interactions, WGE was combined with other ingredients known to act on complementary biological pathways that converge into a single efficacy outcome; in this case, cellular TG levels. Ingredients that had effects on both glucose and fatty acid metabolism that could ultimately synergize with the DGAT-1 pathway were chosen. The complementary pathway targets chosen for these experiments were Peroxisome-Proliferator-Activated Receptor-gamma Coactivator 1-alpha (PGC1-α) and Sterol Regulatory Element Binding Protein 1c (SREBP1c).
In the cellular DGAT-1 model, grape seed extract (GSE) resulted in a significant inhibition of DGAT-1 activity when combined with WGE. The combination index (CI), a quantitative measure of synergy, indicated a strong synergistic effect (CI = 0.61). Synergy occurred at a 1:1 ratio of WGE to GSE, and at ratios that induced no effect on DGAT-1 activity when either was used alone. The synergy data, together with the proof of mechanism clinical data, forms the basis for conducting the presently proposed clinical trial at a WGE level below that used in the previous study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboInactive capsules |
| Low Dose Grape Blend | Active comparator | Dietary Supplement: Low Dose Grape BlendLow dose grape blend providing 375 mg whole grape extract + 375 mg grape seed extract/d (750 mg total botanical extracts/d). |
| High Dose Grape Blend | Active comparator | Dietary Supplement: High Dose Grape BlendHigh dose grape blend providing 500 mg whole grape extract + 500 mg grape seed extract/d (1000 mg total botanical extracts/d) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is male or female, 18-70 years of age, inclusive.
- Subject has a fasting TG concentration of ≥150 and <500 mg/dL at visit 1b (week -1). One venous retest allowed for 145-149 and 500-550 mg/dL values.
- Subject has a body mass index (BMI) of 25.00-34.99 kg/m2 at visit 1b (week -1).
- Subject is willing to maintain habitual diet and physical activity patterns during the study period.
- Subject has no plans to change smoking habits during the study period, and if a current smoker, subject is willing to refrain from all tobacco products for 1 h prior to all clinic visits in addition to up to 9 h during the test visits.
Key exclusion criteria (10 listed)
- Subject has abnormal laboratory test results of clinical significance at visit 1b (week -1), at the discretion of the Investigator. One re-test will be allowed on a separate day prior to visit 2 (week 0), for subjects with abnormal laboratory test results.
- Subject has a history or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric or biliary disorders.
- Subject has a history or current GI disorder that, in the judgment of the Investigator, may have the potential to disrupt normal digestion and absorption of dietary fats, including, but not limited to, Crohn's disease, inflammatory bowel disease, irritable bowel syndrome, significant lactose intolerance and/or egg allergy.
- Subject has a known genetic predisposition to hyperlipidemia - as diagnosed by a health care professional.
- Subject is a heavy smoker, defined as a history of smoking >1 pack-per-day in the 3 months prior to visit 1b (week -1).
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 |
|---|---|---|
| PlaceboThree placebo capsules consumed prior to breakfast each day for 4 weeks | Dietary supplement | Placebo |
| Low Dose Grape BlendThree low dose grape blend capsules consumed prior to breakfast each day for 4 weeks. | Dietary supplement | Low Dose Grape Blend |
| High Dose Grape BlendThree high dose grape blend capsules consumed prior to breakfast each day for 4 weeks. | Dietary supplement | High Dose Grape Blend |
Primary outcome
Fasting triglycerides
Time frame: Baseline and at the end of each 4 week treatment period for a total of 12 weeks
Change in fasting plasma TG
5 secondary outcomes
Area under the curve (AUC) for plasma TG
Time frame: Baseline and the end of each 4 week treatment period for a total of 12 weeks
Maximal Concentration (Cmax) and time to Cmax (Tmax)
Time frame: Baseline and at the end of each 4 week treatment period for a total to 12 weeks
Plasma TG during the OFTT
Time frame: Baseline and at the end of each 4 week treatment period for a total of 12 weeks
Fasting lipoprotein lipids
Time frame: Baseline and at the end of each 4 week treatment period for a total of 12 weeks
Body weight
Time frame: Baseline and at the end of each 4 week treatment period for a total of 12 weeks
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 Mar 2015.
- Background: PubMed 22911105Ables GP, Yang KJ, Vogel S, Hernandez-Ono A, Yu S, Yuen JJ, Birtles S, Buckett LK, Turnbull AV, Goldberg IJ, Blaner WS, Huang LS, Ginsberg HN. Intestinal DGAT1 deficiency reduces postprandial triglyceride and retinyl ester excursions by inhibiting chylomicron secretion and delaying gastric emptying. J Lipid Res. 2012 Nov;53(11):2364-79. doi: 10.1194/jlr.M029041. Epub 2012 Aug 21.
- Background: PubMed 18768481Cheng D, Iqbal J, Devenny J, Chu CH, Chen L, Dong J, Seethala R, Keim WJ, Azzara AV, Lawrence RM, Pelleymounter MA, Hussain MM. Acylation of acylglycerols by acyl coenzyme A:diacylglycerol acyltransferase 1 (DGAT1). Functional importance of DGAT1 in the intestinal fat absorption. J Biol Chem. 2008 Oct 31;283(44):29802-11. doi: 10.1074/jbc.M800494200. Epub 2008 Sep 3.
- Background: PubMed 17449588Chun OK, Chung SJ, Song WO. Estimated dietary flavonoid intake and major food sources of U.S. adults. J Nutr. 2007 May;137(5):1244-52. doi: 10.1093/jn/137.5.1244.
- Background: PubMed 22950654Denison H, Nilsson C, Kujacic M, Lofgren L, Karlsson C, Knutsson M, Eriksson JW. Proof of mechanism for the DGAT1 inhibitor AZD7687: results from a first-time-in-human single-dose study. Diabetes Obes Metab. 2013 Feb;15(2):136-43. doi: 10.1111/dom.12002. Epub 2012 Sep 30.
- Background: PubMed 24240933Martin SS, Blaha MJ, Elshazly MB, Toth PP, Kwiterovich PO, Blumenthal RS, Jones SR. Comparison of a novel method vs the Friedewald equation for estimating low-density lipoprotein cholesterol levels from the standard lipid profile. JAMA. 2013 Nov 20;310(19):2061-8. doi: 10.1001/jama.2013.280532.
- Background: PubMed 21872749Swinburn BA, Sacks G, Hall KD, McPherson K, Finegood DT, Moodie ML, Gortmaker SL. The global obesity pandemic: shaped by global drivers and local environments. Lancet. 2011 Aug 27;378(9793):804-14. doi: 10.1016/S0140-6736(11)60813-1.
- Background: PubMed 18757836Yen CL, Stone SJ, Koliwad S, Harris C, Farese RV Jr. Thematic review series: glycerolipids. DGAT enzymes and triacylglycerol biosynthesis. J Lipid Res. 2008 Nov;49(11):2283-301. doi: 10.1194/jlr.R800018-JLR200. Epub 2008 Aug 29.
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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.
Andrea Lawson, MD principal investigator
Biofortis; 211 East Lake Street; Addison, IL 60101
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose Grape Blend and High Dose Grape Blend in people with Hyperlipidemia, run by Access Business Group 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 8 inclusion and 10 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 Mar 2015. 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?
Fasting triglycerides (time frame: Baseline and at the end of each 4 week treatment period for a total of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02366156, which also lists 7 linked publications.
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 Mar 2015.