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FORZE GPS CLINICAL STUDIES

Obesity Research

A NOVEL NUTRIENT FORMULATION, DELAYS GASTRIC EMPTYING TO A GREATER EXTENT THAN AN EQUICALORIC GLUCOSE MEAL. TANYA J. LITTLE, DAVID THOMPSON, Salford, UK; Manchester, UK Obesity Vol. 15 Suppl, A57, 2007

Background: It is well established that nutrients, present in the gastrointestinal tract, slow the rate of gastric emptying and thereby influence fullness and suppress subsequent energy intake. The extent to which this occurs is dependent on the nutrient composition of the ingested meal. Forze GPS is a novel low-calorie (50 kcal/236 ml) nutritional formulation that has been shown to reduce caloric intake and extend the feeling of satiety following a fixed calorie meal. Whether the mechanism by which Forze GPS, ingested as a preload, suppresses appetite is mediated by the slowing of gastric emptying is unknown.

Aims: To determine whether Forze GPS would delay gastric emptying, suppress appetite and reduce the maximum tolerated volume of water, when compared with equicaloric glucose, and a non-nutrient control meal.

Methods: 8 healthy subjects (5 male, 3 female) of normal body weight were studied on three occasions following a 12-hour overnight fast, in a double-blind, randomized fashion. The effects of chocolate-flavored test meals consisting of (i) Forze GPS (50 kcal), (ii) equicaloric glucose and (iii) low-nutrient control (5.3 kcal) on gastric emptying (13C acetate breath test) and appetite perceptions were assessed over 45 min.

Results: Gastric emptying was delayed to a greater extent, with cumulative 13CO2:12CO2 values being ~30 % lower following Forze GPS ingestion, when compared with glucose and control (* P < 0.05, Figure 1), with no difference between glucose and control.

Conclusions: Forze GPS delays gastric emptying more potently than an equicaloric glucose meal. This effect would make Forze GPS a valuable dietary aid when used prior to meal ingestion, in conjunction with reduced caloric intake.

Trial 1

Effect of a Premeal Beverage Containing a Nutritional Composition Designed to Stimulate Cholecystokinen (CCK) on Post Meal Satiety. R. Portman, PacificHealth Laboratories, Inc., Woodbridge, NJ, A. Bakal, ABIC International Consultants, Fairfield, NJ, S.R. Peiken, Robert Wood Johnson Medical School, Camden, NJ

Objective: Measure the effect of the on the Forze GPS Formulation on satiety in human subjects
# Subjects: 10 Age: 20-57 BMI: 19-25

Format: Double blind, placebo controlled

Design: Subjects participated in two satiety tests. They were given the Forze GPS Formulation or a placebo and then consumed a 340-calorie meal. Following consumption of the meal they recorded their ratings of hunger and how much food they could consume on a visual analog scale every 15 minutes for 3½ hours.

Results: Subjects receiving the Forze GPS Formulation experienced a 30% decrease in hunger versus those who received the placebo and showed a 44% decrease in prospective food consumption. The differences were significant at p < .05.

Conclusions: This study demonstrated that the Forze GPS Formulation was more effective than the placebo in reducing hunger 3½ hours after consumption of a meal.

Trial 2

Effect of a Premeal Beverage Designed to Stimulate Cholecystokinin (CCK) on Post Meal Satiety and Subsequent Caloric Intake. R. Portman, PacificHealth Laboratories, Inc., Woodbridge, NJ, A. Bakal, ABIC International Consultants, Fairfield, NJ, S.R. Peikin, Robert Wood Johnson Medical School, Camden, NJ

Objective: Measure the effect of the Forze GPS RTD Formulation on caloric intake of a second meal consumed 3½ hours after an initial one.

Number of Subjects: 20
Age: 32-55
BMI: 25-30

Format: Double blind, placebo controlled

Design: Subjects participated in two satiety tests. They were given the Forze GPS RTD Formulation or a placebo and then consumed a 340-calorie meal. Following consumption of the meal they recorded their ratings of hunger and satiety every 15 minutes using a visual analog scale. Three and a half hours later subjects consumed an open-ended meal consisting of macaroni and cheese. The amount of food consumed was weighed and recorded.

Results: Compared to a placebo beverage, the Forze GPS RTD Formulation decreased hunger from 75 minutes through 210 minutes. At 210 minutes hunger was 45.9% less in the Forze GPS RTD Formulation trial. Similar results were seen for satiety. After 3½ hours, subjects receiving the Forze GPS RTD Formulation consumed 154 calories versus 297 calories for the placebo trial. All results were significant at p < .05.

Conclusions: This study demonstrated that the Forze GPS RTD Formulation significantly extended the feeling of fullness and decreased feelings of hunger over 3½ hours. The Forze GPS RTD Formulation also reduced caloric intake by 14% in a second meal consumed 3½ hours later.

Trial 3

The Effect of a Nutritional Composition Added to Low-Fat Yogurt on Post-Meal Satiety. R. Portman, PacificHealth Laboratories, Inc., Woodbridge, NJ, A. Bakal, ABIC International Consultants, Fairfield, NJ, S.R. Peikin, Robert Wood Johnson Medical School, Camden, NJ

Objective: To measure the effect of the Forze GPS technology on hunger and satiety when applied to different product formats/formulations.

Number of Subjects: 10
Age: 20-57
BMI: 19-24

Format: Double blind, placebo controlled

Design: Subjects were administered two separate satiety tests, with a minimum 48-hour washout period. Subjects were required to eat the same breakfast at the same time 3 hours before the test. In each of the satiety tests, subjects consumed 8 oz of low-fat yogurt containing the Forze GPS technology on one occasion and a placebo mixture on the other occasion. Following consumption of the yogurt, subjects rated hunger and fullness using a computer every 15 minutes for 3.5 hours after the meal.

Results: Hunger ratings for the yogurts containing the Forze GPS technology were significantly decreased relative to the control, reaching a peak of 45% at 75 minutes. At 135 minutes, hunger ratings for the Forze GPS formulated yogurt were 34% lower than the control/placebo. Fullness followed a similar trend. The differences were significant at p<0.05.

Conclusions: This study demonstrated that the Forze GPS technology can be effectively transferred to other foods/product formats, thereby imparting an incremental level of satiety/hunger reduction.

Trial 4

Effect of a Meal Replacement Drink Designed to Stimulate Cholecystokinin (CCK) on Post-Meal Satiety Compared to a Commercial Meal Replacement Drink and Placebo. R. Portman, PacificHealth Laboratories, Inc., Woodbridge, NJ, A. Bakal, ABIC International Consultants, Fairfield, NJ, S.R. Peikin, Robert Wood Johnson Medical School, Camden, NJ

Objective: To measure the effect of the Forze GPS Formulation on caloric intake.

Number of Subjects: 20
Age: 21-45
BMI: 25-30

Format: Double blind, placebo controlled, crossover

Design: Three treatments were tested. Subjects were given a beverage containing the Forze GPS technology, SlimFast chocolate meal replacement shake or a calorically-controlled placebo. They were then provided with a pasta lunch and instructed to consume as much food as they wished within 25 minutes. The amount of food consumed was measured and recorded. Following lunch, subjects were asked to complete visual analog scale assessments for hunger, fullness and how much food they wanted to eat. VAS assessments were recorded immediately after lunch and 30, 60, 90, 120, 150 and 180 minutes after lunch.

Results: Subjects receiving the Forze GPS technology showed a 21.1% reduction in caloric intake compared to subjects consuming the SlimFast beverage. Subjects receiving the ForzeGPS technology also demonstrated a 27% reduction in caloric intake compared to subjects receiving the placebo (p < 0.5). There was also an extension of satiety at three hours as measured by the VAS ratings.

Conclusions: This study demonstrated that the Forze GPS Formulation decreased caloric intake. Additionally, subjects consuming the Forze GPS Formulation demonstrated an increase in feelings of satiety when compared to the placebo despite consuming significantly fewer calories.

SUPPORTING (CLAIMS) SCIENCE

Claim: CCK is a natural appetite control mechanism

  • The satiety effect of cholecystokinin: a progress report. Smith GP; Gibbs J; Jerome C; Pi Sunyer FX; Kissileff HR; Thornton J Peptides, 1981, 2 Suppl 2:, 57-9
  • Cholecystokinin and satiety in rats and rhesus monkeys. Gibbs J; Smith GP Am J Clin Nutr, 1977 May, 30:5, 758-61
  • Cholecystokinin elicits the complete behavioral sequence of satiety in rats. Antin J; Gibbs J; Holt J; Young RC; Smith GP J Comp Physiol Psychol, 1975 Sep, 89:7, 784-90
  • Cholecystokinin-decreased food intake in rhesus monkeys. Gibbs J; Falasco JD; McHugh R Am J Physiol, 1976 Jan, 230:1, 15-18
  • Role of CCK in satiety and appetite control. Smith GP; Gibbs Clin Neuropharmacol, 1992, 15 Suppl 1 Pt A:, 476A
  • Are gut peptides a new class of anorectic agents? Smith GP; Gibbs J Am J Clin Nutr, 1992 Jan, 55:1 Suppl, 283S-285S
  • Satiating effect of cholecystokinin. Smith GP; Gibbs J Ann N Y Acad Sci, 1994 Mar, 713:, 236-41

Claim: After you eat CCK is released

  • The regulation of food intake by peptides. Woods SC; Gibbs J Ann N Y Acad Sci, 1989, 575:, 236-43

Claim: CCK release reduces food consumption

  • C-terminal octapeptide of cholecystokinin decreases food intake in man. Kissileff HR; Pi Sunyer FX; Thornton J; Smith GP Am J Clin Nutr, 1981 Feb, 34:2, 154-60
  • Effect of a soup preload on reduction of food intake by cholecystokinin in humans. Muurahainen NE; Kissileff HR; Lachaussée J; Pi Sunyer FX Am J Physiol, 1991 Apr, 260:4 Pt 2, R672-80
  • C-terminal octapeptide of cholecystokinin decreases food intake in obese men. Pi Sunyer X; Kissileff HR; Thornton J; Smith GP Physiol Behav, 1982 Oct, 29:4, 627-30
  • Effects of cholecystokinin-octapeptide (CCK-8) on food intake and gastric emptying in man. Muurahainen N; Kissileff HR; Derogatis AJ; Pi Sunyer FX Physiol Behav, 1988, 44:4-5, 645-9
  • Cholecystokinin octapeptide decreases intake of solid food in man. Stacher G; Steinringer H; Schmierer G; Schneider C; Winklehner S Peptides, 1982 Mar, 3:2, 133-6
  • Metabolic and hormonal controls of food intake: highlights of the last 25 years--1972-1997. Campfield LA Appetite, 1997 Oct, 29:2, 135-52
  • Satiety effects of cholecystokinin and ceruletide in lean and obese man. Stacher G Ann N Y Acad Sci, 1985, 448:, 431-6

Claim: FORZE GPS is designed to stimulate CCK release because it contains proteins, glycomacropeptide, oleic acid and calcium.

  • Regulation of cholecystokinin secretion by intraluminal releasing factors. Liddle RA Am J Physiol, 1995 Sep, 269:3 Pt 1, G319-27
  • Release of cholecystokinin in humans after ingestion of glycomacropeptide. Corring T, Beaufrere B, Maubois JL
  • Effects of caseinomacropeptide (CMP) on digestion regulation. Yvon M; Beucher S; Guilloteau P; Le Huerou Luron I; Corring T Reprod Nutr Dev, 1994, 34:6, 527-37
  • Intraduodenal free fatty acids rather than triglycerides are responsible for the release of CCK in humans. Guimbaud R; Moreau JA; Bouisson M; Durand S; Escourrou J; Vaysse N; Frexinos J Pancreas, 1997 Jan, 14:1, 76-82
  • Concentrations of secretin and CCK in plasma and pancreatico-biliary secretion in response to intraduodenal acid and fat. Schaffalitzky de Muckadell OB; Olsen O; Cantor P; Magid E Pancreas, 1986, 1:6, 536-43
  • Release of cholecystokinin and secretin by sodium oleate in dogs: molecular form and bioactivity. Sun G; Chang TM; Xue WJ; Wey JF; Lee KY; Chey WY Am J Physiol, 1992 Jan, 262:1 Pt 1, G35-43
  • Effects of oleic acid and oleyl alcohol on cholecystokinin and secretin in plasma and pancreatobiliary secretion. Olsen O; Ainsworth M; Schaffalitzky de Muckadell OB; Cantor P Scand J Gastroenterol, 1989 Jun, 24:5, 529-32
  • Proteins but not amino acids, carbohydrates, or fats stimulate cholecystokinin secretion in the rat. Liddle RA; Green GM; Conrad CK; Williams JA Am J Physiol, 1986 Aug, 251:2 Pt 1, G243-8
  • Pancreatic, gallbladder, and gastric responses to intraduodenal calcium perfusion in man. Holtermuller KH; Mallagelada JR; McCall JT; Go VL Gastroenterology, 1976 May, 70:5 PT.1, 693-6