Obesity Clinical Trial
Official title:
Nuts in Relation to Markers of Adiposity, Overweight, and Obesity: A Series of Systematic Reviews and Meta-analyses of Randomized Controlled Trials and Prospective Cohort Studies
NCT number | NCT02654535 |
Other study ID # | INC-Nuts 2015 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | September 2021 |
Verified date | October 2021 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Peanuts and tree nuts (almonds, pistachios, walnuts, pecans, pine nuts, Brazil nuts, cashews, hazelnuts, macadamia nuts) (herein referred to as "nuts") are a good source of unsaturated fatty acids, vegetable protein, fibre, and polyphenolics. Nut intake has been associated with reduced cardiovascular disease risk and claims for this association have been permitted by the FDA; however, intake of tree nuts is low in Canada. One of the barriers to increasing the consumption of nuts is the perception that they may contribute to weight gain more than other "healthy foods" owing to their high energy density. The evidence supporting this concern, however, is lacking. In a series of earlier systematic reviews and meta-analyses, we have shown that nuts improve glycemic control and metabolic syndrome criteria, findings which run contrary to any expected weight gain. However, it remains unclear whether nuts have an increasing, neutral, or even decreasing effect on body weight. To address the uncertainties, the investigators propose to conduct a series of systematic reviews and meta-analyses of the totality of the evidence from randomized controlled trials and prospective cohort studies to investigate the effect of nut consumption on body weight and adiposity. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design
Status | Completed |
Enrollment | 1 |
Est. completion date | September 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria for randomized controlled trials: - Trials in adults (>=18 years) - Tree nut and/or peanut intervention - Presence of an adequate comparator (substitution, addition, subtraction, or ad libitum control) - Diet duration >=3 weeks - viable outcome data Inclusion Criteria for prospective cohort studies: - Prospective cohort studies or case-cohort studies - Duration >= 1 year - Assessing adults (>=18 years) - Assessment of the exposure of tree nuts and/or peanuts - Ascertainment of viable data by level of exposure Exclusion Criteria for randomized controlled trials: - non-human trials - assessing individuals <18 years - observational studies - lack of suitable comparator diet (i.e. a comparator arm that contains substantial amounts of tree nuts or peanuts) - Diet duration <3-weeks - No viable outcome data Exclusion Criteria for prospective cohort studies: - Ecological, cross-sectional, and retrospective observational studies, clinical trials, and non-human studies - Duration < 1 year - assessing individuals <18 years - No assessment of exposures of tree nuts and/or peanuts - No ascertainment viable clinical outcome data by level of exposure |
Country | Name | City | State |
---|---|---|---|
Canada | The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
John Sievenpiper | The Physicians' Services Incorporated Foundation |
Canada,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incident overweight or obesity (prospective cohort studies) | Incident overweight or obesity | Up to 40 years | |
Primary | Body weight (randomized controlled trials) | Body weight | Up to 40 years | |
Secondary | Global measures of adiposity with established clinical relevance - body weight (prospective cohort studies) | Body weight | Up to 40 years | |
Secondary | Global measures of adiposity with established clinical relevance - BMI (prospective cohort studies and randomized controlled trials) | Body mass index (BMI) | Up to 40 years | |
Secondary | Global measures of adiposity with established clinical relevance - body fat (prospective cohort studies and randomized controlled trials) | Percentage body fat | Up to 40 years | |
Secondary | Regional measures of adiposity with established clinical relevance - waist circumference (prospective cohort studies and randomized controlled trials) | Waist circumference | Up to 40 years | |
Secondary | Regional measures of adiposity with established clinical relevance - waist-to-hip ratio (prospective cohort studies and randomized controlled trials) | Waist-to-hip ratio | Up to 40 years | |
Secondary | Regional measures of adiposity with established clinical relevance - visceral adipose tissue (prospective cohort studies and randomized controlled trials) | Visceral adipose tissue (VAT) | Up to 40 years |
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