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Completed

NCT Number: NCT00604448

The Effect of Eating Pulses for 8 Weeks on Satiety and Metabolic Syndrome Risk Factors in Overweight Individuals

In 2004, almost 60% of adult Canadians were overweight or obese. This is a serious health concern due to the burden of common health risks associated with being overweight and obese, including increased blood sugar, blood lipids and blood pressure. Together these risks are known as metabolic syndrome. Obesity, the most common nutrition problem in Canada, can in many cases be treated through changes in our diet (what we eat and/or how much we eat). Pulses (beans, chickpeas, lentils and peas) when eaten on a regular basis may result in decreased health risks associated with being overweight and obese. The purpose of this study is to find out whether eating pulses (5 cups per week) results in improvements in metabolic syndrome risk factors. We also want to determine whether the consumption of pulses alters the levels of satiety hormones (hormones that make us feel hungry or full) in the blood. This study will have 50 participants.

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Key information

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leadership Sinai Centre for Diabetes, Mt. Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

The primary objective of this study is to compare the effect of consuming 5 cups per week of commercially available pulses on body weight, satiety and metabolic syndrome risk factors in overweight/obese adults over 8 weeks with a conventional energy restriction diet.

The amount of pulses to be included in the study protocol is based on the USDA Dietary Guideline of 3 cups of pulses per week, but is somewhat high at 5 cups/week. Both groups will receive counseling from a registered dietitian. Pulses will be provided free of charge, delivered weekly to each participant and instructions will be given on their preparation. Subjects will be asked to complete a pulse log to record the date and time of day the pulses are consumed, as well as the type of pulse and other foods consumed during the pulse meal. Cooked pulses will be provided in canned or frozen forms. After completing the meal, subjects will be asked to fill out information (ID, date and time) on the sealed sticker attached to each can or inserted into the frozen pulses portion. In order to measure compliance, subjects will be asked to return all stickers at the end of the week, when new foods are provided to them. For those in the energy restriction group, the dietitian will a have a defined amount of time to advise on how to reduce caloric intake by 500 kcal per day at week 1 (the start of the study) and week 4 (halfway through the study). In addition, the dietitian will obtain a food history and ask additional pulse consumption questions at week 1 and week 8. Also, a 24 h food recall will be obtained from subjects by a dietitian at weeks 1, 4 and 8.

For all subjects, body weight, waist girth, blood pressure, fasting blood lipids, glucose, insulin and satiety hormones will be measured at weeks 1, 4 and 8. Each subject will arrive at the same chosen time for each session, between 8:00 and 10:00 a.m. Upon arrival, subjects will fill out a Sleep Habits and Stress Factors Questionnaire and a Food Intake and Activity Questionnaire. For each session, subjects will be asked to arrive after an overnight fast; only water will be allowed until 1 hour before blood collection.

Blood glucose and insulin response to a glucose load (75 g) will be determined at weeks 1 and 8. For this test (an oral glucose tolerance test), an indwelling catheter will be inserted in the antecubital vein by a nurse and blood samples will be taken at prior to (-15 minutes) and at 0, 10, 20, 30, 60, 90 and 120 minutes after the consumption of a 75 g glucose drink. A total of 90 ml of blood will be sampled at weeks 1 and 8. A single fasting blood sample (20 ml of blood) will also be obtained at week 4 for the same analysis. The week 1 and week 8 sessions will last a maximum of 4 hours and the week 4 session will last a maximum of 2 hours.

Blood samples will be analyzed for glucose, insulin, leptin, ghrelin, glucagon-like peptide-1 (GLP-1), low-density lipoprotein (LDL), triglyceride (TG), C-reactive protein, C-peptide, adiponectin and glycosylated hemoglobin (HbA1c).

Pulses will be obtained from Can Grow Foods, Heinz or purchased from the supermarket.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • overweight/obese adults
  • body mass index: 27-35 kg/m2
  • individuals not prescribed medications over the past 6 months that could interfere with the study outcomes (i.e. statins or metformin)

Exclusion criteria

  • smokers
  • those on an energy restricted diet
  • breakfast skippers
  • pregnant/lactating women

Treatment and study plan

Dietary Advise

Other

Subjects in energy-restricted group will follow dietician advise to keep a conventional energy restriction diet.

Other names: Energy-restricted group

Diet enriched with a meal containing pulses

Other

Subjects in pulse group will consume the commercially available pulses for 8 weeks

Other names: Pulse group

Primary outcomes

  1. blood glucose, lipids and satiety hormones

    Time frame: 4 months

Secondary outcomes

  1. body weight, waist circumference and blood pressure

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Mount Sinai Hospital, Canada

Registry information

Official study title

The Effect of Frequent Consumption of Pulses for Eight Weeks on Blood Lipids and on Glycemic and Satiety Hormones Response in Overweight and Obese Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jan 30, 2008
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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