References:

*As part of a diet

†A randomized, controlled, parallel 6 month trial with metabolic syndrome patients. Patients were randomized to three treatment groups: American Heart Association Step 2 Diet n=45, American Heart Association Step 2 Diet + Psyllium 3.5g BID n=46, American Heart Association Step 2 Diet + Partially Hydrolysed Guar Gum 3.5 g BID n=46.

‡A double-blind, placebo-controlled, parallel, multicenter study evaluated the long-term effectiveness of Metamucil (5.1 grams twice daily, n= 197) and cellulose placebo (5.1 grams twice daily n= 51), as an adjunct to diet in the treatment of patients with primary hypercholesterolemia. Eligible patients completed an 8-week dietary adaptation phase with dietician counselling on AHA step 1 diet (weeks -8 to -1) followed by a 26-week treatment phase (weeks 0–26) and continued AHA step 1 diet with counselling.

§A meta-analysis of 8 pivotal efficacy trials was conducted to evaluate the hypercholesterolemic effects of Metamucil (10.2 grams daily, n=384) and placebo (10.2 grams daily n=272) adjunctive to a low-fat diet for ≥ 8 weeks in individuals with mild-to-moderate hypercholesterolemia after a low-fat diet lead-in phase lasting ≥ 8 weeks.

** Study 1: A single center, randomized, double-blind, placebo-controlled, 4-way cross-over study enrolled 30 healthy patients (19 men/11 women), 28 patients completed the study. Patients were randomized to 4 different groups: placebo and 3 different doses of psyllium fibre (3.4 g, 6.8 g, and 10.2 g) were taken before a controlled, regular breakfast and lunch. Patients spent 3 consecutive days in each group with a 4- to 5-day washout period between treatments. All patients received a single daily dose on their first day. The doses of 3.4 g and 6.8 g were given twice a day on the second and the third day. The dose of 10.2 g was given only once a day. All patients started the study receiving only 1 dose of psyllium fibre on the first day before breakfast to assess the potential impact of 3 single different doses on satiety responses. Three Satiety endpoints were self-assessed every half hour for a total of 19 per day: hunger and desire to eat on independent Visual Analog Scales (VAS) and hunger/fullness on the Satiety Labeled Intensity Magnitude (SLIM) scale.

††Scores averaged across all post-prandial measurement times and days were lower significantly or directionally (p ≤ 0.025 and p ≤ 0.052, respectively) for all psyllium doses vs. placebo.

‡‡ Study 2: A randomized, double-blind, placebo-controlled, 2-treatment, 3-period cross-over with a new group of patients. Forty-four healthy patients (25 men/19 women) were enrolled and 40 completed the study. Patients took 6.8 g of psyllium or placebo before receiving an energy-restricted breakfast. 6.8 g psyllium or placebo was given before lunch on days 1 & 2 but no dose before lunch on day 3. On each dosing day, patients consumed a breakfast providing an energy equivalent to 15%-20% of their estimated individual resting energy expenditure, but with the same proportions of carbohydrates, protein, and fibre as study 1 (50% carbohydrate, 34% fat, 16% protein). Satiety endpoints were assessed every 30 minutes by self-ratings of hunger and desire to eat on independent Visual Analog Scales (VAS) and hunger/fullness on the Satiety Labeled Intensity Magnitude (SLIM) scale.