Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/04/2007
Date assigned
12/06/2007
Last edited
12/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sylvie Dodin

ORCID ID

Contact details

45 rue Leclerc
local D6-721
Québec
G1L 2G1
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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 women’s 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

Approval received from the ethical committee of the clinical research of the St-Francois d'Assise Hospital on the 26th October 2006.

Study design

Randomised controlled study design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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 Canada’s 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

27/11/2006

Overall trial end date

01/03/2008

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

132

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

Trial participating centre

45 rue Leclerc
Québec
G1L 2G1
Canada

Sponsor information

Organisation

Pulse Canada (Canada)

Sponsor details

1212 - 220 Portage Avenue
Winnipeg
R3C 0A5
Canada
+1 204 925 4455
office@pulsecanada.com

Sponsor type

Industry

Website

http://www.pulsecanada.com

Funders

Funder type

Industry

Funder name

Pulse Canada (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes