There were no serious AEs, or withdrawals due to AEs, reported in either study4
Metamucil supplementation before meals was well-tolerated and significantly increased satiety by: 4
- > Increasing fullness
- > Decreasing hunger
- > Reducing the desire to eat between meals
References:
1. Cicero AFG et al. Psyllium improves dyslipidaemia, hyperglycaemia and hypertension, while guar gum reduces body weight more rapidly in patients affected by metabolic syndrome following an AHA Step 2 diet. Meiterr J Nutr Metab. 2010;3:47–57. 4. Metamucil® Preparations product monograph. Procter & Gamble Canada.
2. Anderson JW et al. Long-term cholesterol-lowering effects of psyllium as an adjunct to diet therapy in the treatment of hypercholesterolemia. Am J Clin Nutr 2000;71(6):1433-8.
3. Anderson JW et al. Cholesterol lowering effects of psyllium intake adjunctive to diet therapy in men and women with hypercholesterolemia: meta-analysis of 8 controlled trials. Am J Clin Nutr 2000;71(2):472-9.
4. Brum JM et al. Satiety effects of psyllium in healthy volunteers. Appetite 2016;(105):27–36.
*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.
‡Among recommendations in ProVoice™ surveys 2015 to 2021 (OTC Bulk Fibre category).