Impact of Almond Supplementation on Body Composition in Overweight/Obese Minority Adults
Condition: Obesity; Overweight; Fatty Liver; Metabolic Syndrome X
MeSH terms: Fatty Liver; Microvascular Angina; Overweight; Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether introducing almonds into the diet of
      overweight and obese Blacks and Hispanics improves body composition, decreases liver fat, and
      lowers cardiovascular disease profile.
    

Detailed description: 
      The study is a randomized, controlled study aimed at testing whether almonds, consumed within
      a free-living, self-selected diet, improve body composition and liver fat, relative to a
      low-fat/high-carbohydrate cereal bar (LF-HC) in overweight and obese Blacks and Hispanics. A
      secondary aim is to determine whether almond consumption will lead to an overall lower CVD
      risk profile.

      Participants will be randomized to consume approximately 17.5% of their estimated energy
      requirements from almonds daily (2-3 oz) or a high-carbohydrate cereal bar (2 g of fat or
      less per 100 kcal) providing an equivalent amount of calories. Prescribed energy requirements
      will be determined for each participant individually using the Mifflin St Jeor Equation
      equation with an activity factor of 1.3. Participants will be asked to consume half of their
      food supplement as a mid-afternoon snack and the rest at a meal of their choice.

      At the baseline visit, participants will be given a 2-week supply of their allocated food
      supplement and will obtain additional supplies at bi-weekly visits for the first 8 weeks.
      After the week 8 visit, participants will be given monthly rations of their food supplement,
      either almonds or LF-HC cereal bar, and will be asked to come to research center every 4
      weeks to obtain their next supply. At those visits, body weight and blood pressure will be
      measured and participants will turn in weekly dietary diaries, reporting their supplement
      intake. Participants will also receive one random phone call every 4 weeks to provide a 24-h
      recall. This recall will be used as an index of dietary quality but also as a compliance
      check with dietary supplements. In addition, 3-day food records will be collected prior to
      the start of the study and during the final week to assess any dietary changes due to the
      intervention. A food frequency questionnaire will also be administered at screening and
      endpoint of the study. This food-frequency questionnaire will target nut consumption.

      At the end of the study, intention to continue eating almonds or a low-fat diet will be
      assessed using questions adapted from de Bruijn et al. Participants in the almond group will
      be asked the following questions: (1) "I intend to include almonds in my diet" (+2 = yes,
      definitely; -2 = no, definitely); (2) "How certain are you that you will include almonds in
      your diet?" (+2 = very certain; -2 = very uncertain); (3) "Including almonds in my diet is"
      (instrumental attitude: +3 = healthy; -3 = unhealthy; affective attitude: +3 = pleasant; -3 =
      unpleasant); (4) "I find including almonds in my diet" (perceived behavioral control: +3 =
      easy; -3 = difficult). Corresponding questions for the control group will replace "include
      almonds" with "reduce the amount of fat". Participants will be called 4 weeks later to obtain
      information on their actual almond and fat intakes by questionnaire and 24-h recall.
    

Intervention name(s): Almond; Cereal Bar
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from almonds daily for 24 weeks. Prescribed energy requirements will be determined for each participant individually using the Mifflin St Jeor Equation equation with an activity factor of 1.3. Participants will be asked to consume half of their daily almond supplement as a mid-afternoon snack and the rest at a meal of their choice.; Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from cereal bars daily for 24 weeks. Prescribed energy requirements will be determined for each participant individually using the Mifflin St Jeor Equation equation with an activity factor of 1.3. Participants will be asked to consume half of their daily cereal bar supplement as a mid-afternoon snack and the rest at a meal of their choice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Body Weight; Cardiovascular Diseases; Cholesterol; Almonds; Visceral Adiposity; Quality of Life; Hispanic Americans; African Continental Ancestry Group; Metabolic Syndrome X