NCT02366156

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 12, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

October 15, 2014

Last Update Submit

March 11, 2015

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Fasting triglycerides

    Change in fasting plasma TG

    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

    Baseline and the end of each 4 week treatment period for a total of 12 weeks

  • Maximal Concentration (Cmax) and time to Cmax (Tmax)

    Baseline and at the end of each 4 week treatment period for a total to 12 weeks

  • Plasma TG during the OFTT

    Baseline and at the end of each 4 week treatment period for a total of 12 weeks

  • Fasting lipoprotein lipids

    Baseline and at the end of each 4 week treatment period for a total of 12 weeks

  • Body weight

    Baseline and at the end of each 4 week treatment period for a total of 12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Inactive capsules

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).

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)

Dietary Supplement: High Dose Grape Blend

Interventions

PlaceboDIETARY_SUPPLEMENT

Three placebo capsules consumed prior to breakfast each day for 4 weeks

Placebo
Low Dose Grape BlendDIETARY_SUPPLEMENT

Three low dose grape blend capsules consumed prior to breakfast each day for 4 weeks.

Low Dose Grape Blend
High Dose Grape BlendDIETARY_SUPPLEMENT

Three high dose grape blend capsules consumed prior to breakfast each day for 4 weeks.

High Dose Grape Blend

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis

Addison, Illinois, 60101, United States

Location

Related Publications (7)

  • 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.

    PMID: 22911105BACKGROUND

  • Cheng 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.

    PMID: 18768481BACKGROUND

  • Chun 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.

    PMID: 17449588BACKGROUND

  • Denison 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.

    PMID: 22950654BACKGROUND

  • Martin 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.

    PMID: 24240933BACKGROUND

  • Swinburn 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.

    PMID: 21872749BACKGROUND

  • Yen 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.

    PMID: 18757836BACKGROUND

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Andrea Lawson, MD

    Biofortis; 211 East Lake Street; Addison, IL 60101

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2014

First Posted

February 19, 2015

Study Start

July 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 12, 2015

Record last verified: 2015-03

Locations

US(1)