Effect of Dried Fruit Intake on Acid-base Balance

NCT04030351 | Terminated

• 1 other identifier: 2980
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Most adults consume acid-producing diets because their high intake of protein and/or cereal grains in relation to their intake of fruits and vegetables. This study is being done to determine whether acid-base balance can be restored by the addition of dried fruits to the diet. In this study adults with low usual fruit intake will be provided with either 100 g per day of a mix of dried fruits or no dried fruit. Participants will be followed for 1 year. Acid-base status will be assessed by measuring the acid content in 24-hour urine collections.

Conditions

Acid-Base Balance Disorder

Outcome Measures

Primary Outcomes (1)

• change in 24-hour urinary NAE

  NAE reflects net acid-base balance

  12 month

Secondary Outcomes (13)

• rate of adherence with dried fruit

  12 months

• change in 24-hour urinary N-telopeptide

  12 months

• change in fat to lean tissue mass ratio

  12 months

• change in bone mineral density at the total body

  12 months

• change in body weight

  12 months

Study Arms (2)

dried fruit

EXPERIMENTAL

100 g per day of dried fruit

Other: food - dried fruit

no dried fruit

NO INTERVENTION

no intervention to be given

Interventions

food - dried fruit OTHER

raisins, apricots, figs, and pineapple

dried fruit

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• usual self-reported fruit intake not greater than 2.5 servings per day
• adequate dentition to chew dried fruit
• willing to avoid potassium supplements during the study
• willing to avoid antacids other than Pepto Bismol during the study

You may not qualify if:

• Conditions
• diabetes or fasting plasma glucose on screening \>125 mg/dl
• untreated thyroid disease
• untreated parathyroid disease
• cirrhosis
• unstable heart disease
• osteoporosis of the spine or hip
• alcohol use \> 2 drinks per day
• chronic diarrheal syndrome
• estimated glomerular filtration rate \< 50 ml/min
• serum potassium \>5.3 meq/L
• abnormal serum calcium
• dysphasia
• malabsorption
• inflammatory bowel disease

Sponsors & Collaborators

• Tufts University: lead
• Tufts Medical Center: collaborator

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Bone Metabolism Laboratory

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 23, 2019
• Study Start: August 27, 2018
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)