Metabolic Effects of Almond in the Longer-term Study (MEAL)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Almonds 43g/day
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Almonds, Body weight, Snacking
Eligibility Criteria
Inclusion Criteria:
- Not taking any medication known to affect glycemia, lipid metabolism or appetite
- Regular breakfast consumers
- Eat at least 5 meals a day
- Weight stable
- Either one of the 6 conditions
- BMI 27-35
- Family history of diabetes
- Fasting glucose between 6.1-6.9 mmol/L
- 2-hour glucose 7.8-11.1 mmol/L
- blood pressure >130/85 mmHg
- Waist >102cm (men) and >88cm (women)
Exclusion Criteria:
- Nut allergy
- Not willing to eat test foods and almonds
Sites / Locations
- Purdue University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
No Intervention
Arm Label
Breakfast
Morning snack
Lunch
Afternoon snack
Control no nuts
Arm Description
Almonds (43g/day) were consumed with breakfast for four weeks.
Almonds (43g/day) were consumed alone as morning snacks for four weeks.
Almonds (43g/day) were consumed with lunch for four weeks.
Almonds (43g/day) were consumed alone as afternoon snacks for four weeks.
Avoided all nuts and seeds
Outcomes
Primary Outcome Measures
Postprandial glucose, insulin and lipids
Responses of these parameters to a standard breakfast and a standard lunch for all participants, plus almonds at designated times according to group randomization.
Anthropometric measurements
Changes in body weight, BMI, fat mass, waist circumference over 4 weeks
Fasting blood biochemistries
Fasting glucose, insulin and lipids at baseline, week-1, 2, 3 and 4
Dietary intake
Dietary intakes were assessed at baseline, week-2, and week-4 of study
Secondary Outcome Measures
Blood pressure
Blood pressure measurements at baseline and final week of study
Appetite ratings
Postprandial appetite sensations
Full Information
NCT ID
NCT01690936
First Posted
September 12, 2012
Last Updated
May 28, 2013
Sponsor
Purdue University
Collaborators
Almond Board of California
1. Study Identification
Unique Protocol Identification Number
NCT01690936
Brief Title
Metabolic Effects of Almond in the Longer-term Study
Acronym
MEAL
Official Title
Effects of Chronic Almond Consumption at Meals or as Snacks on Appetite, Intake, Body Weight, Glycemia, Insulinemia and Lipids in Healthy Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Almond Board of California
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Identifying snacks that do not contribute to positive energy balance is crucial in weight management. The satiating effects of almonds, coupled with their convenience and palatability make them a promising weight management aid. Therefore, this study aimed to examine the effects of almond consumption with meals versus snacks on outcomes such as appetite, energy intake, body weight, as well as blood glucose, insulin and lipid responses.
Detailed Description
Experiment protocol and measurements
i) Oral glucose tolerance test (OGTT) sessions
At baseline, participants attended a session where a standard OGTT with drinks containing 75 grams dextrose was performed following an overnight fasting. Serum glucose and insulin concentrations were measured at 0 and 120 minutes of the session. During the same session, height, weight (Tanita), body fat (air displacement plethysmography, BOD POD), waist circumference, and blood pressure were measured. Participants also completed a 24-hour dietary recall using a multi-pass interview method and standard questionnaires that assessed personality, eating behavior and habitual physical activity levels during the OGTT session. After the completion of this session, participants were asked to record their hourly appetite sensations, measured as "hunger", "fullness" and "desire to eat" on visual analog scales, during waking hours for a day before attending the next (clinical) visit. Participants repeated this session after four weeks of almond consumption.
ii) Acute feeding sessions
Within a week following the OGTT session, participants returned for an acute-feeding session, after an overnight fasting of at least 10 hours. This session began between 7:00 am and 8:00 am, and lasted for approximately 515 minutes. Upon arrival, an indwelling arm catheter was placed in the upper arm for blood sample collection. Participants rested for 15 minutes after catheter placement, before a baseline blood sample was drawn. Immediately after the first blood sample collection, a standard breakfast was served, and participants were instructed to consume the entire portion within 10 minutes. Subsequent blood samplings were performed at 15, 45, 60, 90, 120, 180, and 240 minutes after the breakfast, before a standard lunch was provided to the participants. Again, participants were given 10 minutes to consume the lunch, before blood samples were taken at similar intervals again (at 265, 295, 310, 340, 370, 430, and 490 minutes of the session). Participants randomized into the BF and LN groups received 43 grams of almonds together with their meals, while the MS and AS groups consumed 43 grams of almonds 120 minutes after breakfast and lunch respectively. Participants also recorded their "hunger", "fullness", and "desire to eat" sensations when blood samples were taken. During the acute-feeding session, activities that may alter appetite sensations (e.g. sleeping and watching movies containing food cues) were prohibited. Postprandial glucose, insulin and triacylglycerol concentrations were measured for all 15 samples collected from each participant. Participants in all almond groups group were also asked to rate their likings for the almonds they ingested using a general label magnitude scale, and their action responses to almonds using the "food action rating scale", a visual analog scale ranging from "I would eat the almonds only if I were forced to" to "I would eat this food every opportunity I had" anchored to the 2 extremes. This session was repeated again after four weeks of almond supplementation.
iii) Weekly follow-ups
Following the baseline acute-feeding session, participants were asked to consume 43 grams of almonds every day at times based on their group randomization. The CL group was instructed to avoid all nuts and seeds in the diet during the study period. All almonds were dry-roasted and lightly salted, and were pre-weighed and per-packaged for convenience. Except for the permission to adjust dietary intake due to almond supplement, participants were asked to maintain their dietary intakes and physical activity levels. A ruse (breath analysis) was introduced in order to enhance the compliance of participants to consuming almonds at the designated times of day. Compliance to almond consumption was assessed through fasting plasma α-tocopherol. Participants attended weekly visit (week-1, 2 and 3) after an overnight fasting, during which body weight was recorded and compliance to study protocol reinforced. During the week-2 visit, participants were also asked to complete a 24-hour dietary intake assessment using the multi-pass interview method and appetite sensation ratings on VAS at every waking hour for a day. On week-4, participants returned for OGTT and acute-feeding sessions as described above. The study protocol was approved by the Purdue University Institutional Review Board.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Almonds, Body weight, Snacking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breakfast
Arm Type
Experimental
Arm Description
Almonds (43g/day) were consumed with breakfast for four weeks.
Arm Title
Morning snack
Arm Type
Experimental
Arm Description
Almonds (43g/day) were consumed alone as morning snacks for four weeks.
Arm Title
Lunch
Arm Type
Experimental
Arm Description
Almonds (43g/day) were consumed with lunch for four weeks.
Arm Title
Afternoon snack
Arm Type
Experimental
Arm Description
Almonds (43g/day) were consumed alone as afternoon snacks for four weeks.
Arm Title
Control no nuts
Arm Type
No Intervention
Arm Description
Avoided all nuts and seeds
Intervention Type
Dietary Supplement
Intervention Name(s)
Almonds 43g/day
Intervention Description
43 grams of almonds were supplemented to the 4 intervention arms but eaten at different times of day (with meals or alone as snacks) for 4 weeks. Control group was asked to avoid all nuts/seeds during the study period
Primary Outcome Measure Information:
Title
Postprandial glucose, insulin and lipids
Description
Responses of these parameters to a standard breakfast and a standard lunch for all participants, plus almonds at designated times according to group randomization.
Time Frame
490 minutes
Title
Anthropometric measurements
Description
Changes in body weight, BMI, fat mass, waist circumference over 4 weeks
Time Frame
4 weeks
Title
Fasting blood biochemistries
Description
Fasting glucose, insulin and lipids at baseline, week-1, 2, 3 and 4
Time Frame
4 weeks
Title
Dietary intake
Description
Dietary intakes were assessed at baseline, week-2, and week-4 of study
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure measurements at baseline and final week of study
Time Frame
Baseline and week-4
Title
Appetite ratings
Time Frame
Baseline, week-2, and week-4
Title
Postprandial appetite sensations
Time Frame
490 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Not taking any medication known to affect glycemia, lipid metabolism or appetite
Regular breakfast consumers
Eat at least 5 meals a day
Weight stable
Either one of the 6 conditions
BMI 27-35
Family history of diabetes
Fasting glucose between 6.1-6.9 mmol/L
2-hour glucose 7.8-11.1 mmol/L
blood pressure >130/85 mmHg
Waist >102cm (men) and >88cm (women)
Exclusion Criteria:
Nut allergy
Not willing to eat test foods and almonds
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Mattes, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
12. IPD Sharing Statement
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Metabolic Effects of Almond in the Longer-term Study
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