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About
One out of two adults in Canada is currently overweight and therefore at increased risk for a number of medical conditions including diabetes, high blood pressure, heart attacks and stroke. Obesity is less prevalent in populations consuming large amounts of dietary fibre, suggesting that fibre intake could play an important role in prevention and progression of obesity and diabetes and other conditions. Several studies have suggested that fibre has a positive effect on blood sugar and may help lower body weight.
The purpose of this study is to help better understand the effect of adding fibre supplementation to a low calorie diet on blood sugar control and weight loss. The investigators hypothesize that blood sugar control will improve in participants in the fibre supplementation group.
Men and women, with stable Type 2 Diabetes (e.g. no medication change in the last 3 months), between 18 - 75 years of age, and with a Body Mass Index (BMI) between 27 - 60 kg/m2 can participate in this study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
HbA1c <7.0% or >10.0%
History of any bariatric surgery
>10 Kg weight gain or weight loss in the past 3 months
Known eating disorder
Participant has taken weight loss medication in the last 3 months (eg. Meridia, Xenical)
Participant is taking any of the following medications that can alter body weight or appetite:
Antipsychotics or neuroleptics
Prednisone
Antidepressants
Note: The following antidepressants are NOT exclusion medications:
SSRIs such as citalopram (Celexa), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil)
Wellbutrin
SNRIs such as venlafaxine (Effexor), duloxetine (Cymbalta)
Participant is taking any of the following natural health products that can alter body weight or appetite: ephedra, synephrine, green tea extracts, daily use of bulk fibre laxatives (e.g. psyllium, glucomannan)
Participant not eligible for enrolment in a medically supervised LCD program at the Wharton Medical Clinic (WMC only accepts patients by referral from a family physician. To be eligible patients must have a BMI ≥ 30 or ≥ 27 with at least one obesity related comorbidity.)
Patient with a past history of severe hypoglycaemia (as defined by the Diabetes Control and Complications Trial (DCCT)) whether or not on insulin, sulfonylureas and non-sulfonylurea secretogogues
Patient with documented hypoglycemic unawareness, whether or not on insulin, sulfonylureas and non-sulfonylurea secretogogues
Achalasia (i.e. difficulty swallowing)
Patient is taking medication that targets GLP-1 (glucagon-like peptide-1) including GLP-1 analogues (e.g. Byetta (Exenatide), Victoza (Liraglutide)) and DPP-IV inhibitors (e.g. Januvia(Sitagliptin), Onglyza (Saxagliptin).
Positive urine pregnancy test, pregnancy, breast feeding, or hormonal contraceptives started in the last 6 months prior to the start of the study
Absence of a highly effective method of birth control for female of childbearing potential (premenopausal or not surgically sterile) OR does not plan to use contraception for the duration of study participation AND does not agree to periodic urine pregnancy testing during the study. ICH M3 defines a highly effective method of birth control as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Substance abuse: tobacco (including those who have quit smoking in the last 12 months), Cannabis sativa, or other controlled substances use
Any allergies to study product ingredients including dairy, whey, rice, soy and or coconut.
Labile or uncontrolled hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg)
Current diagnosis or history of gastrointestinal diseases or disorders (with the exception of Irritable Bowel Syndrome and GERD at the discretion of qualified investigator).
Heart failure
Substantial neurological or psychological illness within the last 6 months (at the discretion of qualified investigator)
Contraindications to LCD
Participant cannot fully understand all instructions in English.
Any other medical, social or geographic condition, which, in the opinion of the qualified investigator would not allow safe completion of the protocol.
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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