A psyllium-enriched cereal for the treatment of hypercholesterolemia in children: a controlled, double-blind, crossover study.

Psyllium, a water-soluble fiber, has been shown to lower total serum and low-density-lipoprotein (LDL)-cholesterol concentrations in adult hypercholesterolemic subjects and may be effective in the treatment of hypercholesterolemia in children. The effects of a psyllium-enriched cereal were compared with a matched control cereal in a double-blind, crossover fashion in 25 children, 6-18 y old, with hypercholesterolemia. After an 8-wk diet-stabilization period, the subjects were randomly assigned to receive the active or control cereals for 6 wk, followed by a 6-wk washout period and a 6-wk crossover treatment period. Whereas no changes were noted in total and LDL-cholesterol concentrations during consumption of the control cereal, significant changes were seen during the psyllium-cereal periods [0.31 mmol/L (12.1 mg/dL) and 0.28 mmol/L (10.9 mg/dL); P = 0.03 and 0.01, respectively]. The psyllium-enriched cereal was well tolerated throughout the trial. Consumption of the psyllium-enriched cereal resulted in a modest 7% reduction in LDL-cholesterol concentrations compared with the control cereal when used in this pediatric hypercholesterolemic sample. Psyllium offers a potential adjunct to a low-fat diet for the treatment of hypercholesterolemia in the pediatric population because of its ease of incorporation into various foods.

Long-term effects of consuming foods containing psyllium seed husk on serum lipids in subjects with hypercholesterolemia.

The effects of consuming foods containing 0 (control), 3.4, 6.8, or 10.2 g psyllium seed husk (PSH)/d for 24 wk on the serum lipid profile were assessed in this randomized, double-blind controlled study. Men and women (n = 286) with LDL-cholesterol concentrations between 3.36 and 5.68 mmol/L (130 and 220 mg/dL) were randomly assigned to one of four treatment groups after following a low-fat diet for > or = 8 wk. At week 24, LDL cholesterol was 3% above baseline in the control group. In the group consuming 10.2 g PSH/d, LDL cholesterol remained below baseline during treatment, with a value 5.3% below that of the control group at week 24 (P < 0.05 compared with the control group). No significant differences were observed in HDL cholesterol or triacylglycerol. Although modest, the effect of 10.2 g PSH/d on LDL cholesterol (relative to the control) persisted throughout the 24-wk treatment period, indicating potential for long-term benefit.

Olestra dose response on fat-soluble and water-soluble nutrients in humans.

Ninety normal healthy adults were given 0, 8, 20 or 32 g/d olestra for 8 wk as part of a diet that provided 1 +/- 0.2 of the recommended dietary allowance (RDA) of vitamins A, D, E and K, folate zinc, calcium and iron. In addition, a 20 microg/d supplement of vitamin D was supplied. The diet provided 15% of energy from protein, 35% from fat and 55% from carbohydrate. The purpose of the study was to determine the dose response of olestra on vitamins D, E and K, carotenoids, vitamin B12, folate and zinc. Circulating concentrations of retinol, carotenoids, tocopherols, 25-hydroxy- and 1,25-dihydroxyvitamin D metabolites, phylloquinone, des-gamma-carboxyprothrombin, prothrombin, folate and hematological parameters were measured biweekly, as were urine concentrations of zinc and gamma-carboxyglutamic acid (Gla). Clinical chemistry, urinalysis and vitamin B12 absorption were measured at wk 0 and 8. Olestra reduced serum concentrations of carotenoids, alpha-tocopherol, 25-hydroxyergocalciferol and phylloquinone in a dose-responsive manner. Olestra did not affect Gla excretion, plasma des-gamma-carboxyprothrombin or prothrombin concentrations, prothrombin time, vitamin B12 absorption, overall vitamin D status or the status of folate or zinc. Laboratory evaluations showed no health-related effects of olestra. Subjects in all groups reported common gastrointestinal symptoms such as loose stools, fecal urgency and flatulence, which were transient and generally mild to moderate in severity. These symptoms did not affect protocol compliance or the ability to measure the potential for olestra to affect nutrient availability.

The hypocholesterolemic effects of beta-glucan in oatmeal and oat bran. A dose-controlled study.

Oat cereals rich in the water-soluble fiber beta-glucan have been studied as a dietary therapy for hypercholesterolemia. To determine the hypocholesterolemic response of beta-glucan in the diet, 156 adults with low-density lipoprotein cholesterol (LDL-C) levels above 4.14 mmol/L (160 mg/dL) or between 3.37 and 4.14 mmol/L (130 and 160 mg/dL) with multiple risk factors were randomized to one of seven groups. Six groups received either oatmeal or oat bran at doses (dry weight) of 28 g (1 oz), 56 g (2 oz), and 84 g (3 oz). A seventh group received 28 g of farina (beta-glucan control). At week 6 of treatment, significant differences were found for both total cholesterol and LDL-C levels among the farina control and the treatment groups who were receiving 84 g of oatmeal, 56 g of oat bran, and 84 g of oat bran, with decreases in LDL-C levels of 10.1%, 15.9%, and 11.5%, respectively. Fifty-six grams of oat bran resulted in significantly greater reductions in LDL-C levels than 56 g of oatmeal. Nutrient analysis shows no difference in dietary fat content between these treatment groups; therefore, the higher beta-glucan content of oat bran most likely explains the significantly greater LDL-C reductions. A dose-dependent reduction in LDL-C levels with oat cereals supports the independent hypocholesterolemic effects of beta-glucan.

Olestra's effect on vitamins D and E in humans can be offset by increasing dietary levels of these vitamins.

One hundred two normal healthy males and females were given 0, 8, 20 or 32 g/d olestra to which had been added graded amounts of vitamins A, D and E for 8 wk in a parallel, double-blind study. The primary purpose of the study was to determine the amounts of vitamins D and E needed to offset the effect of olestra on the availability of these vitamins. Serum concentrations of retinol, carotenoids, 25-hydroxyvitamin D metabolites, alpha-tocopherol, phylloquinone, lipids, ferritin and total iron, iron-binding capacity and hematology parameters, plasma concentrations of des-gamma-carboxyprothrombin and prothrombin, and urinary gamma-carboxyglutamic acid (Gla) excretion were measured biweekly. Clinical chemistry and urinalysis parameters, vitamin B12 absorption, and serum 1,25-dihydroxyvitamin D concentration were measured at wk 0 and 8. Serum concentrations of alpha-tocopherol and 25-hydroxyergocalciferol were restored to control concentration by adding 2.1 mg d-alpha-tocopheryl acetate and 0.06 microg ergocalciferol per gram of olestra, respectively, to the diet. Olestra reduced serum concentrations of 25-hydroxyergocalciferol, carotenoids and phylloquinone in a dose-responsive manner but did not affect Gla excretion, plasma des-gamma-carboxyprothrombin and prothrombin concentrations, overall vitamin D status, vitamin B12 absorption or iron status. Laboratory evaluations showed no olestra-related effects. Subjects in all groups reported mild to moderately severe transient gastrointestinal symptoms. These symptoms did not affect study compliance or the integrity of the data.

A low-viscosity soluble-fiber fruit juice supplement fails to lower cholesterol in hypercholesterolemic men and women.

This study was designed to determine whether a soluble dietary fiber supplement containing gum arabic and pectin in apple juice would lower serum lipids in 110 hypercholesterolemic men and women. Subjects were stabilized on an American Heart Association Phase I Diet for 8 wk. Those with elevated low density lipoprotein cholesterol levels, despite dietary modification, continued to follow the diet and were randomly assigned to receive 720 mL/d of apple juice containing 0 (control), 5, 9 or 15 g of gum arabic and pectin (4:1 ratio) for 12 wk, followed by a 6-wk apple juice-only washout phase. Serum lipid profiles, body weight and 3-day diet records were collected at 3-wk intervals. No significant differences among groups were observed in serum lipid responses during treatment or washout. During the treatment phase, mean serum total cholesterol and triglyceride concentrations increased by 3.5 and 28.5%, respectively (all groups combined, P < 0.0001). The high density lipoprotein cholesterol level did not change significantly from baseline in any group. During washout, mean total cholesterol concentration rose by an additional 2.4% (P < 0.05) compared with the value at the end of the treatment period, suggesting that the apple juice used to deliver the fiber supplement may have contributed to the adverse changes observed in the serum lipid profile. These findings do not support the hypothesized hypocholesterolemic effect of the gum arabic/pectin (4:1) mixture studied, but do underline the importance of selecting appropriate vehicles for delivery of dietary fiber mixtures.