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Effects of cactus fiber on the excretion of dietary fat in healthy subjects: a double blind, randomized, placebo-controlled, crossover clinical investigation.

Uebelhack R, Busch R, Alt F, Beah ZM, Chong PW - Curr Ther Res Clin Exp (2014)

Bottom Line: As demonstrated by in vitro studies, cactus fiber binds to dietary fat and its use results in reduced absorption, which in turn leads to reduced energy absorption and ultimately the reduction of body weight.No adverse events were reported throughout the study period.The results of our study support the hypothesis that cactus fiber helps in reducing body weight by binding to dietary fat and increasing its excretion, thus reducing dietary fat available for absorption.

View Article: PubMed Central - PubMed

Affiliation: Universitätsmedizin Charité, Berlin, Germany.

ABSTRACT

Background: Cactus (Opuntia ficus-indica) fiber was shown to promote weight loss in a 3-month clinical investigation. As demonstrated by in vitro studies, cactus fiber binds to dietary fat and its use results in reduced absorption, which in turn leads to reduced energy absorption and ultimately the reduction of body weight.

Objective: The objective of our study was to elucidate the dietary fat binding capacity of cactus fiber through determination of fecal fat excretion in healthy volunteers.

Subjects and methods: This clinical investigation was performed as a double-blind, randomized, placebo-controlled, crossover study in healthy subjects for a period of approximately 45 days. Twenty healthy volunteer subjects were randomized to receive cactus fiber or placebo, 2 tablets thrice daily with main meals. All subjects were provided with meals during the study period (except washout) according to a standardized meal plan, with 35% of daily energy need coming from fat. Two 24-hour feces samples were collected during both the baseline and treatment periods for analysis of the fat content.

Results: Cactus fiber showed an increased fecal fat excretion compared with placebo (mean [SD] = 15.79% [5.79%] vs 4.56% [3.09%]; P < 0.001). No adverse events were reported throughout the study period.

Conclusions: Cactus fiber has been shown to significantly promote fecal fat excretion in healthy adults. The results of our study support the hypothesis that cactus fiber helps in reducing body weight by binding to dietary fat and increasing its excretion, thus reducing dietary fat available for absorption. ClinicalTrials.gov identifier: NCT01590667.

No MeSH data available.


Related in: MedlinePlus

Clinical trial study schedule comparing and analyzing the fecal fat extraction effect of cactus fiber. There were 6 clinical visits (V1–V6) throughout the study period. V1 = screening + blood sampling; V2 = Baseline 1 (subjects were given a standardized meal, with placebo); V3 = subjects compliant to the meal plan and investigational product regimen were randomized to receive cactus fiber or placebo and a 7-day washout period followed; V4 = baseline 2 (similar to Baseline 1); V5 = subjects compliant to the meal plan and investigational product regimen were crossed over to the second treatment arm; V6 = blood sampling. Stool was collected on both Day 5 and Day 6, or Day 6 and Day 7 of baseline and intervention period. IP = investigational product.
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f0005: Clinical trial study schedule comparing and analyzing the fecal fat extraction effect of cactus fiber. There were 6 clinical visits (V1–V6) throughout the study period. V1 = screening + blood sampling; V2 = Baseline 1 (subjects were given a standardized meal, with placebo); V3 = subjects compliant to the meal plan and investigational product regimen were randomized to receive cactus fiber or placebo and a 7-day washout period followed; V4 = baseline 2 (similar to Baseline 1); V5 = subjects compliant to the meal plan and investigational product regimen were crossed over to the second treatment arm; V6 = blood sampling. Stool was collected on both Day 5 and Day 6, or Day 6 and Day 7 of baseline and intervention period. IP = investigational product.

Mentions: The study period was approximately 45 days, as described in Figure 1. Subjects fulfilling all inclusion criteria entered a 7-day baseline period (Baseline 1 [B1]), during which they were provided with a standardized diet containing 35% of fat in total energy required. Daily energy needs were estimated for each subject depending on sex, age, and physical activity.26 Subjects were given a diary at B1 and were instructed to record their daily food intake and to adhere strictly to the meal plan based on the food provided. Inspection of food diary was carried out at every subsequent clinic visit to ensure compliance. All subjects were instructed to take placebo tablets during B1. Subjects compliant with the meal plan and investigational product (IP) regimen during B1 entered a 7-day intervention phase (Intervention 1) and were randomized to either receive cactus fiber tablets or matching placebo, 2 tablets TID after each main meal. Each cactus fiber tablet contains 500 mg standardized cactus fiber, as well as common tableting excipients. Identical placebo tablets were manufactured based on the same formulation, but the active ingredient was replaced by a mixture of microcrystalline cellulose (316.5 mg) and calcium hydrogen phosphate dihydrate (183.5 mg).


Effects of cactus fiber on the excretion of dietary fat in healthy subjects: a double blind, randomized, placebo-controlled, crossover clinical investigation.

Uebelhack R, Busch R, Alt F, Beah ZM, Chong PW - Curr Ther Res Clin Exp (2014)

Clinical trial study schedule comparing and analyzing the fecal fat extraction effect of cactus fiber. There were 6 clinical visits (V1–V6) throughout the study period. V1 = screening + blood sampling; V2 = Baseline 1 (subjects were given a standardized meal, with placebo); V3 = subjects compliant to the meal plan and investigational product regimen were randomized to receive cactus fiber or placebo and a 7-day washout period followed; V4 = baseline 2 (similar to Baseline 1); V5 = subjects compliant to the meal plan and investigational product regimen were crossed over to the second treatment arm; V6 = blood sampling. Stool was collected on both Day 5 and Day 6, or Day 6 and Day 7 of baseline and intervention period. IP = investigational product.
© Copyright Policy - CC BY-NC-ND
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4109417&req=5

f0005: Clinical trial study schedule comparing and analyzing the fecal fat extraction effect of cactus fiber. There were 6 clinical visits (V1–V6) throughout the study period. V1 = screening + blood sampling; V2 = Baseline 1 (subjects were given a standardized meal, with placebo); V3 = subjects compliant to the meal plan and investigational product regimen were randomized to receive cactus fiber or placebo and a 7-day washout period followed; V4 = baseline 2 (similar to Baseline 1); V5 = subjects compliant to the meal plan and investigational product regimen were crossed over to the second treatment arm; V6 = blood sampling. Stool was collected on both Day 5 and Day 6, or Day 6 and Day 7 of baseline and intervention period. IP = investigational product.
Mentions: The study period was approximately 45 days, as described in Figure 1. Subjects fulfilling all inclusion criteria entered a 7-day baseline period (Baseline 1 [B1]), during which they were provided with a standardized diet containing 35% of fat in total energy required. Daily energy needs were estimated for each subject depending on sex, age, and physical activity.26 Subjects were given a diary at B1 and were instructed to record their daily food intake and to adhere strictly to the meal plan based on the food provided. Inspection of food diary was carried out at every subsequent clinic visit to ensure compliance. All subjects were instructed to take placebo tablets during B1. Subjects compliant with the meal plan and investigational product (IP) regimen during B1 entered a 7-day intervention phase (Intervention 1) and were randomized to either receive cactus fiber tablets or matching placebo, 2 tablets TID after each main meal. Each cactus fiber tablet contains 500 mg standardized cactus fiber, as well as common tableting excipients. Identical placebo tablets were manufactured based on the same formulation, but the active ingredient was replaced by a mixture of microcrystalline cellulose (316.5 mg) and calcium hydrogen phosphate dihydrate (183.5 mg).

Bottom Line: As demonstrated by in vitro studies, cactus fiber binds to dietary fat and its use results in reduced absorption, which in turn leads to reduced energy absorption and ultimately the reduction of body weight.No adverse events were reported throughout the study period.The results of our study support the hypothesis that cactus fiber helps in reducing body weight by binding to dietary fat and increasing its excretion, thus reducing dietary fat available for absorption.

View Article: PubMed Central - PubMed

Affiliation: Universitätsmedizin Charité, Berlin, Germany.

ABSTRACT

Background: Cactus (Opuntia ficus-indica) fiber was shown to promote weight loss in a 3-month clinical investigation. As demonstrated by in vitro studies, cactus fiber binds to dietary fat and its use results in reduced absorption, which in turn leads to reduced energy absorption and ultimately the reduction of body weight.

Objective: The objective of our study was to elucidate the dietary fat binding capacity of cactus fiber through determination of fecal fat excretion in healthy volunteers.

Subjects and methods: This clinical investigation was performed as a double-blind, randomized, placebo-controlled, crossover study in healthy subjects for a period of approximately 45 days. Twenty healthy volunteer subjects were randomized to receive cactus fiber or placebo, 2 tablets thrice daily with main meals. All subjects were provided with meals during the study period (except washout) according to a standardized meal plan, with 35% of daily energy need coming from fat. Two 24-hour feces samples were collected during both the baseline and treatment periods for analysis of the fat content.

Results: Cactus fiber showed an increased fecal fat excretion compared with placebo (mean [SD] = 15.79% [5.79%] vs 4.56% [3.09%]; P < 0.001). No adverse events were reported throughout the study period.

Conclusions: Cactus fiber has been shown to significantly promote fecal fat excretion in healthy adults. The results of our study support the hypothesis that cactus fiber helps in reducing body weight by binding to dietary fat and increasing its excretion, thus reducing dietary fat available for absorption. ClinicalTrials.gov identifier: NCT01590667.

No MeSH data available.


Related in: MedlinePlus