Effects of pulse incorporation into the diet on components of the metabolic syndrome, body fatness and food habits in women
| ISRCTN | ISRCTN37849619 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37849619 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/04/2007
- Registration date
- 12/06/2007
- Last edited
- 25/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Sylvie Dodin
Scientific
Scientific
45 rue Leclerc
local D6-721
Québec
G1L 2G1
Canada
Study information
| Study design | Randomised controlled study design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | Effects of pulse incorporation into the diet on components of the metabolic syndrome, body fatness and food habits in women |
| Study hypothesis | We hypothesise that consumption of pulses, which are low in fat and rich in dietary soluble fibres and plant proteins, will lead to beneficial changes in primary components of the metabolic syndrome (waist circumference, blood pressure, fasting plasma triglyceride, High Density Lipoprotein [HDL]-cholesterol, glucose levels and blood pressure), positively modify fatness composition (decrease in body fatness) and will be associated with positive changes in food habits. The general objective of the randomised clinical trial will be to investigate the short- and long-term effects of incorporation of whole pulses (beans, peas, lentils and chickpeas) into the diet of women on components of the metabolic syndrome and percentage of body fat, as well as changes in dietary habits. More specifically, we will investigate: 1. The acute short-term effects (16 weeks) of pulse incorporation into the diet on: 1.1. The primary components of the metabolic syndrome (waist circumference, blood pressure and fasting plasma triglyceride, HDL-cholesterol and glucose levels) 1.2. The secondary components of the metabolic syndrome (insulin sensitivity index and insulinaemia, apolipoprotein A1[apo-A1], apolipoprotein B [apo-B], Lipoprotein a [Lp(a)], Low Density Lipoprotein [LDL] size subfractions, fibrinogen, Plasminogen Activator Inhibitor-1 [PAI-1], C-Reactive Protein [CRP], Interleukin-6 [IL-6], Tumour Necrotising Factor-alpha [TNF-a] and homocysteine), and 1.3. The percentage of body fat evaluated by bioelectrical impedance analysis 2. The long-term effects (eight weeks following the end of the dietary intervention) of participating in a dietary clinical trial and receiving nutritional and health information on: 2.1. Changes in womens dietary habits 2.2. Changes in the foods consumed by their families, and 2.3. Changes in the recommendations they give to their patients |
| Ethics approval(s) | Approval received from the ethical committee of the clinical research of the St-Francois d'Assise Hospital on the 26th October 2006. |
| Condition | Metabolic syndrome, nutrition |
| Intervention | Women will be randomly assigned to either an incorporation of pulse or control meals into their diet, which they will consume for a period of 16 weeks. Women will be seen in the clinical unit for a follow-up check at weeks 8, 16 and 24. During the dietary intervention, both groups will consume five experimental meals per week. Based on the United States Department of Agriculture (USDA) dietary guidelines, pulse meals will be formulated to provide a total of three cups (approximately 600 g) of pulses per week. On a weekly basis, pulse meals will provide the four groups of pulses (beans, peas, lentils and chickpeas) and possibly more than one type of each group. Control meals will be formulated to conform to dietary recommendations of Canadas Food Guide to Healthy Eating with the exception that pulses will be excluded from these meals. All meals (main dishes) will be formulated as ten rotating meals, repeated eight times. Experimental and control meals will be formulated to provide the same content of energy on a weekly basis. |
| Intervention type | Other |
| Primary outcome measure | Primary outcomes will be evaluated at screening, randomisation and weeks 8, 16 and 24. 1. Lipid profile and glycaemia 2. Waist circumference |
| Secondary outcome measures | 1. Plasma levels of apo A-1, apo B and Lp(a) will be measured at randomisation and at week 16 2. LDL particle size will be measured at randomisation and at week 16 3. Plasma haemostatic balance markers: fibrinogen and PAI-1 will be measured at randomisation and at week 16 4. Plasma inflammation mediators: CRP, IL-6 and TNF-a will be measured at randomisation and at week 16 5. Plasma levels of homocysteine will be measured at randomisation and at week 16 6. Insulin sensitivity (Homeostatic Model Assessment version 2 [HOMA2] and Quantitative Insulin Sensitivity Check Index [QUICKI]) will be measured at randomisation and at week 16 7. Blood pressure will be measured at randomisation and each follow-up visit thereafter 8. Anthropometric variables (weight and height) will be measured at randomisation and each follow-up visit thereafter 9. Body composition (fat mass, fat-free mass, percentage of body fat, basal metabolic rate will be assessed by impedance analysis) will be measures at randomisation and each follow-up visit thereafter 10. Dietary habit strength (self-report index of habit strength will be measured at randomisation and at week 24) 11. Eating behaviour (51-item Three-Factor Eating Questionnaire (TFEQ) will be evaluated at baseline and at week 24) 12. Changes in the food consumed by their families (questionnaire related to their food-related activities at home evaluated at week 24) |
| Overall study start date | 27/11/2006 |
| Overall study end date | 01/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 132 |
| Total final enrolment | 134 |
| Participant inclusion criteria | 1. Women between 30 and 65 years of age 2. Have a minimum of two of the following four metabolic risk factors: 2.1. Waist circumference equal to or higher than 88 cm 2.2. Fasting plasma triglycerides equal to or higher than 1.7 mmol/l 2.3. Fasting plasma HDL-cholesterol lower than 1.3 mmol/l 2.4. Fasting blood glucose equal or higher to 5.5 mmol/l |
| Participant exclusion criteria | 1. Personal history of Cardiovascular Disease (CVD) or type two diabetes 2. Uncontrolled hypertension (greater than 140/90 mmHg) 3. Familial hypercholesterolaemia 4. Use of medication that interferes with lipid or glucose metabolism 5. Extreme nutritional habits such vegetarianism 6. Smokers 7. Drink more than two drinks of alcohol per day 8. Have known food allergies |
| Recruitment start date | 27/11/2006 |
| Recruitment end date | 01/03/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
45 rue Leclerc
Québec
G1L 2G1
Canada
G1L 2G1
Canada
Sponsor information
Pulse Canada (Canada)
Industry
Industry
1212 - 220 Portage Avenue
Winnipeg
R3C 0A5
Canada
| Phone | +1 204 925 4455 |
|---|---|
| office@pulsecanada.com | |
| Website | http://www.pulsecanada.com |
Funders
Funder type
Industry
Pulse Canada (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/04/2010 | 25/10/2021 | Yes | No |
Editorial Notes
25/10/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
