A Phase 1/2 interventional study of Almond enriched diet and Low fat caloric diet in Obesity, Metabolic Syndrome X and Hyperlipidemia, sponsored by Temple University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-28.
Sponsored by Temple University · Phase 1/2, Interventional, and Treatment
The purpose of this trial is to study the safety, tolerability and efficacy of an almond enriched hypocaloric diet on weight loss and weight maintenance, as well as on established and emerging cardiovascular risk factors in approximately 112 overweight and obese persons.
A randomized, non-blinded, controlled clinical trial using a parallel design of a hypocaloric, low fat (\<30% energy from fat) diet with or without 2 oz of almonds over 18 months. Interim analyses will be conducted at 3, 6, 9 and 12 months. The study will be divided into 3 phases. Phase 1 (months 0-6) will be an active, intensive weight loss phase. During phase 1, all subjects will meet once a week in the evening for 1.5 hours. Phase 2 (months 6-12) will be a less intensive weight loss phase. During phase 2 groups will meet every other week in the evening for 1.5 hours. The last phase will be the weight maintenance phase or phase 3 (months 12-18).
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 123 is above the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →Temple University is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Almond enriched diet
Behavioral: Almond enriched diet
Low-fat diet
Behavioral: Low fat caloric diet
Subjects will consume 2 oz. of almond per day in addition to a low-fat diet
Also known as: AED
Low fat caloric diet
Also known as: LFD
To evaluate the effects of an almond-enriched (2 oz/day) hypocaloric, low-fat diet on body weight and body composition in overweight and obese persons
Time frame: 6 months
To evaluate the effects of the almond enriched diet on established and emerging surrogate markers of coronoary artery disease (CAD) risk
Time frame: 6 months
The record gives a start of Feb 2005, a primary completion of Oct 2007 and a completion of Oct 2009. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.