Ignite Creation Date:
2024-05-06 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03340298
Status:
COMPLETED
Last Update Posted:
2019-09-20
First Post:
2017-11-05
Brief Title:
Fiber and Cardiovascular Risk Factors
Sponsor:
Isfahan University of Medical Sciences
Organization:
Isfahan University of Medical Sciences
Study Overview
Official Title:
The Effect of a Weight Reducing Diet Containing Different Sources of Fiber on Cardiovascular Risk Factors in Overweight and Obese Women A Randomized Feeding Trial
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 kgm2
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 005 and Type 2 error b of 020 power D 80 Based on a previous study in Iranian women 46 we used a within-group BMI mean difference d of 25 kgm2 and a standard deviation SD of 32 kgm2
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 ClinicalTrialgov 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 111 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 175 g fiber from whole grains and 175 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 05 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 meatsalternatives 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 dwk 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-hd to give the MET-hd values
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 005 and Type 2 error b of 020 power D 80 Based on a previous study in Iranian women 46 we used a within-group BMI mean difference d of 25 kgm2 and a standard deviation SD of 32 kgm2
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 ClinicalTrialgov 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 111 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 175 g fiber from whole grains and 175 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 05 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 meatsalternatives 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 dwk 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-hd to give the MET-hd values
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None