NCT02333461

Study to Evaluate Botanicals for Mechanisms Related to Appetite and Fat Metabolism in Healthy, Overweight and Obese Individuals

Completed NA Last updated 6 January 2015

What this trial tests

NA trial testing Placebo in Overweight in 90 participants. Completed in 1 August 2012.

Timeline

1 May 2012

Primary endpoint
1 August 2012

1 August 2012

Quick facts

Lead sponsor	Access Business Group
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	90
Start date	1 May 2012
Primary completion	1 August 2012
Estimated completion	1 August 2012

Drugs / interventions tested

• Placebo
• Apple
• Grape
• Raspberry
• Apricot/Nectarine

Conditions studied

• Overweight — all drugs for Overweight →
• Obesity — all drugs for Obesity →

Sponsor

Access Business Group — full company profile →

Who can join

Adults 18 to 70, any sex, with Overweight or Obesity. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Serum triglyceride response (area under the curve = AUC) following consumption of a standardized high fat meal challenge.
  Time frame: Six hours
• Plasma acylated ghrelin response (AUC) following consumption of a standardized high fat meal challenge
  Time frame: Three hours

Sponsor's own description

Excess caloric consumption, particularly from inexpensive, energy dense foods that are high in fat and refined carbohydrates, is a major driver of the global obesity epidemic. Dietary supplements that promote reduced intake of energy dense foods and/or impact the absorption and metabolism of fat and carbohydrates in the body can be used to help consumers control their weight. We identified two separate mechanistic approaches to target these effects.

Diacylglycerol acyltransferase-1 (DGAT-1) is an enzyme involved in the formation of dietary fat into circulating triglycerides within the body. Once dietary fat is digested and absorbed, the resulting fatty acids are re-esterified into triglycerides. Inhibition of DGAT-1 results in delayed and decreased re-esterification of dietary fats into circulating triglycerides. It is hypothesized that this effect may lead to decreased deposition of excess dietary fat as adipose tissue, possibly due to increased fatty acid oxidation in the enterocytes.

Ghrelin is a hormone that is known to stimulate appetite in humans. When calorie dense fatty foods are sensed in the stomach, ghrelin is acylated and activated via ghrelin O-acyltransferase (GOAT). The activation step attaches a medium chain fatty acid to the ghrelin molecule that enables it to transmit a signal in the brain that triggers eating and fat storage in adipose tissue. Interfering with the GOAT pathway will inhibit ghrelin activation and possibly diminish food intake and lipid storage. This concept is supported by animal studies in which weight gain in a high fat diet model is prevented when GOAT is inhibited.

Our objective was to determine whether botanicals demonstrating in vitro DGAT-1 and GOAT inhibition have similar mechanistic effects in the human body. Based on the results of this study, prototype formulas may be developed and clinically- tested for outcomes related to weight management.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proanthocyanidins and hydrolysable tannins: occurrence, dietary intake and pharmacological effects.
   Smeriglio A, Barreca D, Bellocco E, Trombetta D. · · 2017 · cited 323× · PMID 27646690 · DOI 10.1111/bph.13630
2. Identification of a botanical inhibitor of intestinal diacylglyceride acyltransferase 1 activity via in vitro screening and a parallel, randomized, blinded, placebo-controlled clinical trial.
   Velliquette RA, Grann K, Missler SR, Patterson J, et al · · 2015 · cited 6× · PMID 26246845 · DOI 10.1186/s12986-015-0025-2