Fiber and Cardiovascular Risk Factors
Fiber and Cardiovascular Risk Factors
This study was a parallel randomized controlled feeding trial conducted in overweight and
 obese participants who were attending the Nutrition Clinic in Isfahan, Iran. Inclusion
 criteria were as follows: women aged 18 to 50 years; body mass index (BMI) 25 kg/m2

 ; having noncommunicable diseases such as diabetes, hyperlipidemia, and hypertension; having
 no history of liver and renal disease, hormonal disorders, food allergy, and other special
 diseases; not taking specific medications affecting weight; willingness to introduce a
 dietary change to lose weight; and habitual daily consumption of fruits, vegetables, and
 whole grains. The exclusion criteria were the following: weight loss of more than 10% of body
 weight within the 6 months before registration in the study; attending a competitive sport;
 no consumption of fruits, vegetables, or whole grains habitually; abnormal thyroid hormone
 concentration; intake of drugs or supplementation that could affect energy expenditure or
 weight; and not following recommended diets or returning for following visits. Recruitment
 ran from January 2016 to July 2016. The sample size was calculated based on the standard
 formula (45):

 by considering the Type 1 error (a) of 0.05 and Type 2 error (b) of 0.20 (power D 80%). Based
 on a previous study in Iranian women (46), we used a within-group BMI mean difference (d) of
 2.5 kg/m2 and a standard deviation (SD) of 3.2 kg/m2

 -  Therefore, we needed 25 participants in each group. The study was approved by the
 research council and ethical committee of the School of Nutrition and Food Science,
 Isfahan University of Medical Sciences, Isfahan, Iran (grant number: 194172). All
 participants gave written consent before study enrollment. This trial was registered at
 ClinicalTrial.gov with code NCT03340298. Study design and interventions A randomized
 feeding trial was designed that aimed to compare the effect of different sources of
 fibers with low-calorie conventional diets on weight loss, waist circumference (WC),
 blood pressure, fasting blood glucose (FBS), and lipid profiles in overweight and obese
 women. Eligible participants were randomly assigned to the three groups after baseline
 measures of BMI, using a computer-generated random numbers method of randomization.
 Seventy-five participants who were eligible for the study were randomly divided to one
 of the three groups ("whole grains" high fiber diet, "fruits and vegetables" high fiber
 diet, and diet containing "whole grains, fruits, and vegetables") in a 1:1:1 allocation
 (Figure 2). Participant allocation was stratified by age and BMI. All participants
 consumed 35 g of fiber per day as follows: in the whole grains group (n D 25), 25 g of
 fiber from whole grain products and 10 g fiber from fruits and vegetables was to be
 consumed with the main meals; in the fruits and vegetables group (n D 25), 25 g of fiber
 from fruits and vegetables and 10 g from whole grain sources was to be consumed with the
 main meals; and in the whole grains, fruits, and vegetables group, participants were to
 consume an equal amount of fiber from both sources (17.5 g fiber from whole grains and
 17.5 g fiber from fruits and vegetables) with their main meals daily for 10 weeks. The
 main meals were determined by an expert dietitian, based on the Harris-Benedict formula,
 considering 0.5 kg weekly weight loss for each participant. The distribution of
 macronutrients was similar among groups (carbohydrates, 55%; fat, 30%; and protein, 15%)
 and the number of servings of each food group was estimated and given to participants.
 Participants in each group were given their allowed food that contained a list of
 exchangeable foods, food groups, and subgroups (Table 2). All participants were
 instructed to attend the nutrition clinic to take their intended products. Participants
 were supplied with the fruits, vegetables, and whole grains for their diet and they
 consumed these food items under supervision in the nutrition clinic for 10 weeks. Other
 components of their weight loss diets, such as dairy, meats/alternatives, and fat groups
 were asked to be consumed in a free-living situation. To assess compliance of
 participants' intake of weight loss diets, participants were asked to record their
 24-hour food intakes for 3 d/wk during weeks 2, 5, and 10 of the trial. Duration of all
 physical activities was collected, similar to dietary intakes. To obtain the metabolic
 equivalent for daily physical activity, the recorded physical activities were multiplied
 by the relevant metabolic equivalents task hours per day (MET-h/d) to give the MET-h/d
 values.
Inclusion Criteria:

 overweight or obese

 Exclusion Criteria:

 have any diseases